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Global regulations and guidance

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Continuing the Global regulations and guidance list, 1000 records per page.

  1. European Medicines Agency publishes first review of orphan designation
  2. March 29 2016 GSR 357(E)
  3. Committee for medicinal products for veterinary use: Meeting of 12-14 February 2008
  4. Organisation Management System (OMS) Trouble Shooting Session for CTIS users - November…
  5. ema-prepandrixPrepandrix
  6. Becoming a member of one of EMA’s scientific advisory groups
  7. 21 CFR 864.8175: Calibrator for platelet counting.
  8. PSUSA/00000986/202109 - periodic safety update report single assessment
  9. TEAM-NB-Contact-Transfer-NB
  10. cdsco-deucravacitinibDeucravacitinib
  11. Committee for Medicinal Products for Human Use (CHMP): 17-20 September 2012
  12. PIC/S Recommendation How to Evaluate and Demonstrate the Effectiveness of the…
  13. Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 July 2022
  14. Drug Safety Update: monthly PDF newsletter: September 2020 Drug Safety Update
  15. 21 CFR 74.2322: D&C Red No. 22.
  16. EU/3/24/2905 - orphan designation for treatment of multiple myeloma
  17. cdsco-ly3841136LY3841136
  18. EU/3/20/2344 - orphan designation for treatment of acute lymphoblastic leukaemia
  19. ema-jevtanaJevtana
  20. ICH Quality Implementation Working Group: points to consider for ICH Q8/Q9/Q10 guidelines…
  21. Lumateperone Tosylate 42mg capsule
  22. 21 CFR 866.5360: Cohn fraction IV immunological test system.
  23. EU/3/05/326 - orphan designation for treatment of systemic sclerosis
  24. Novosis Goserelin - referral
  25. PSUSA/00002673/201512 - periodic safety update report single assessment
  26. ema-pumarixPumarix
  27. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  28. PSUSA/00001308/201603 - periodic safety update report single assessment
  29. Pertuzumab concentrate for solution for Infusion (rDNA origin) (420mg/14mL)
  30. cdsco-biapenem-300-mg-injBiapenem 300 mg inj
  31. Risk of Eye and Skin Injuries from Hand-held Laser Pointers: FDA Safety Communication
  32. Clean Before Sterile! Discussing a New Medical Device Standard, ANSI/AAMI ST98
  33. PSUSA/00001158/201911 - periodic safety update report single assessment
  34. Microbiological Pharmaceutical Quality Control Labs (7/93)
  35. European Medicines Agency launches call for expression of interest from healthcare…
  36. PSUSA/00003086/202112 - periodic safety update report single assessment
  37. Committee for Advanced Therapies (CAT): 12-14 July 2017
  38. Flukicides for which no maximum residue limit has been established in milk and which are…
  39. Committee for Advanced Therapies (CAT): 8-9 March 2012
  40. 21 CFR 10.25: Initiation of administrative proceedings.
  41. PSUSA/00000958/201709 - periodic safety update report single assessment
  42. PSUSA/00001212/201707 - periodic safety update report single assessment
  43. 2026.01.28 G.S.R. 66(E)_Draft Notification for consideration of Navi Mumbai International…
  44. Good Human Organ, Tissue and Cell Practice, Good Human Organ ,Tissue and Cell Practice
  45. Paediatric Committee (PDCO): 20-23 July 2021
  46. Guidance for the use of medicinal cannabis in Australia: Patient information
  47. Magnetic resonance imaging equipment in clinical use: safety guidelines: Safety guidelines…
  48. Intraversial SN-38 Lipid Suspension
  49. 21 CFR 822.35: Can you inspect my manufacturing site or other sites involved in my…
  50. GN-02-R7 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2025 Oct)…
  51. EU/3/16/1664 - orphan designation for treatment of homocystinuria
  52. European Medicines Agency and Massachusetts Institute of Technology launch joint project…
  53. Clinical investigations in Northern Ireland
  54. EU/3/13/1115 - orphan designation for treatment of mantle cell lymphoma
  55. EU/3/05/296 - orphan designation for treatment of congenital adrenal hyperplasia
  56. EU/3/11/859 - orphan designation for treatment of chondrosarcoma
  57. News update from veterinary unit 14 April 1997: centralised procedure for authorisation of…
  58. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7–9 November 2017
  59. Committee for Medicinal Products for Veterinary Use (CVMP): 21-23 March 2023
  60. EMEA-001501-PIP07-20 - paediatric investigation plan
  61. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 July 2026
  62. Kirsty (previously Kixelle)
  63. ema-enspryngEnspryng
  64. Dienogest / ethinylestradiol (as betadex clathrate) / L-5-methyltetrahydrofolic acid…
  65. 21 CFR 878.4100: Organ bag.
  66. PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to…
  67. EMEA-001131-PIP01-11 - paediatric investigation plan
  68. cdsco-sibeprenlimabSibeprenlimab
  69. cdsco-exenatideExenatide
  70. EMEA-000347-PIP05-20 - paediatric investigation plan
  71. Committee for Advanced Therapies (CAT): 11-13 August 2021
  72. European Medicines Agency closed 17-21 April 2014
  73. ema-finance-proceduresFinance procedures
  74. GN-06-R3 Guidance on Distribution Records(2022 Nov)_PUB [PDF, 246 KB]
  75. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - January 2015
  76. Liquiritiae radix - herbal medicinal product
  77. EMEA-001006-PIP05-18-M01 - paediatric investigation plan
  78. Annex1 Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in…
  79. Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
  80. cdsco-naptumomab-estafenatoxNAPTUMOMAB ESTAFENATOX
  81. Mounjaro - opinion on variation to marketing authorisation
  82. EMEA-000458-PIP01-08 - paediatric investigation plan
  83. English Translations of Guidelines for Bioequivalence Studies of Generic Products
  84. EU/3/15/1469 - orphan designation for treatment of ovarian cancer
  85. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 6…
  86. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - March 2017
  87. ema-trixeo-aerosphereTrixeo Aerosphere
  88. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 October…
  89. cdsco-desidustat-tabDesidustat tab
  90. 21 CFR 820.70: Production and process controls.
  91. Enfortumab vedotin 30 mg
  92. Compounding of Offences under the Drugs and Cosmetics Act, 1940 in accordance with the…
  93. EU/3/02/126 - orphan designation for treatment of angioedema
  94. Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020 (SI…
  95. Confirmation, etc. of the status of pre-approval GMP compliance inspection for new drugs
  96. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare…
  97. 21 CFR 874.5840: Antistammering device.
  98. Pharmaceutical Good Manufacturing Practice Regulations
  99. Aspartame and phenylalanine
  100. February 1st 2018 GSR 104(E)
  101. 21 CFR 874.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  102. ICH Q4B Annex 3 Test for particulate contamination: sub-visible particles - Scientific…
  103. PSUSA/00002834/202308 - periodic safety update report single assessment
  104. EU/3/04/229 - orphan designation for treatment of hepatocellular carcinoma
  105. EMEA-001006-PIP02-15 - paediatric investigation plan
  106. EU/3/16/1611 - orphan designation for treatment of epidermolysis bullosa
  107. EMEA-001776-PIP02-17-M01 - paediatric investigation plan
  108. EU/3/03/174 - orphan designation for treatment of glioma
  109. 21 CFR 872.3980: Endosseous dental implant accessories.
  110. PSUSA/00000471/201602 - periodic safety update report single assessment
  111. Aloes folii succus siccatus - herbal medicinal product
  112. Documentation for implementation of data requirements under the new Post-Market…
  113. Guidance: How to demonstrate foreign building compliance with drug good manufacturing…
  114. EU/3/01/058 - orphan designation for prevention of delayed graft function in organ…
  115. FDA Partners with Health Canada in Launching Joint “eSTAR” Pilot
  116. Povidone Iodine Nasal Solution 0.5% w/vCT/SND/21/2023
  117. EU/3/07/499 - orphan designation for treatment of pulmonary arterial hypertension and…
  118. ema-sprycelSprycel
  119. Extended EudraVigilance medicinal product dictionary (XEVMPD) training
  120. 21 CFR 862.1370: Human growth hormone test system.
  121. Clarification reg NOC to import of diagnostics kit or reagent dated 27.12.2012
  122. 21 CFR 20.101: Administrative enforcement records.
  123. ema-edarbiEdarbi
  124. Paediatric addendum to the guideline on clinical investigation on medicinal products in…
  125. cdsco-20102010
  126. Guidance document for Veterinary Biologicals
  127. Vildagliptin + Metformin Hydrochloride IP Film coated bilayered sustained release tablets…
  128. Committee for Medicinal Products for Human Use (CHMP): 14-17 August 2023
  129. European Medicines Agency and EUnetHTA review progress of their cooperation
  130. Management Board: Meetings 2017
  131. EU/3/13/1201 - orphan designation for prevention of graft-versus-host disease
  132. EMEA-001266-PIP02-14 - paediatric investigation plan
  133. EU/3/15/1602 - orphan designation for treatment of anal cancer
  134. Checklist/ Performa to be provided for verification of information on allergen IVD by…
  135. 21 CFR 882.1890: Evoked response photic stimulator.
  136. EU/3/21/2525 - orphan designation for treatment of invasive candidiasis
  137. EMEA-001811-PIP02-15-M04 - paediatric investigation plan
  138. EU/3/15/1541 - orphan designation for treatment of marginal zone lymphoma
  139. 21 CFR 20.34: Search for records.
  140. cdsco-dec22-2009-g-s-r-917-eDec22,2009(G.S.R_917(E)
  141. cdsco-romosozumabRomosozumab
  142. Joint European Medicines Agency (EMA) / European Organisation for Research and Treatment…
  143. Involving young people in EMA activities
  144. First treatment for rare liver disease
  145. Clinical evidence guidelines
  146. P/87/2010 - paediatric investigation plan
  147. 21 CFR 888.3220: Finger joint metal/polymer constrained cemented prosthesis.
  148. EU/3/14/1286 - orphan designation for treatment of chronic lymphocytic leukaemia / small…
  149. Pregabalin (as sustained release) IP + Methylcobalamin IP + Nortriptyline Hydrochloride IP…
  150. FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for…
  151. Joint Meeting of the Drug Safety and Risk Management Advisory Committee and…
  152. EMEA/H/N/PSR/S/0009 - periodic safety update report single assessment
  153. ema-coliprotec-f4Coliprotec F4
  154. NOTICE - Stickering of Pharmaceuticals as per Act and Rules relating to Goods & Service…
  155. 21 CFR 864.3800: Automated slide stainer.
  156. EMEA-001004-PIP01-10 - paediatric investigation plan
  157. EU/3/13/1194 - orphan designation for treatment of Duchenne muscular dystrophy
  158. 21 CFR 73.615: Turmeric oleoresin.
  159. cdsco-kshn001126KSHN001126
  160. EMEA-002153-PIP01-17-M01 - paediatric investigation plan
  161. Silodosin + Tdalafil IP hard gelatin capsule (Phase III)
  162. EudraVigilance training on electronic reporting of individual case safety reports in the…
  163. Repeal of wholesale dealer licence exemption for pharmacists: Guidance on repeal of…
  164. Medical Devices alert 07.04.2017
  165. PSUSA/00003086/201512 - periodic safety update report single assessment
  166. Fukushima S. Regulatory Trends of Antibody Therapeutics in Japan. Global Bio Conference…
  167. EMEA-000560-PIP03-15-M01 - paediatric investigation plan
  168. Urosdexycholic Acid Tablet 150/mg/300 mg
  169. 21 CFR 864.6550: Occult blood test.
  170. First meeting of the EMEA Scientific Committees' Working Party with with Patients' and…
  171. Azelnidipine Olmesartan Medoxomil IP tablets
  172. PSUSA/00010502/202207 - periodic safety update report single assessment
  173. 2025.03.12_S.O. 1159(E)_Reconstitution of Drugs Technical Advisory Board (DTAB)
  174. 21 CFR 868.5100: Nasopharyngeal airway.
  175. 21 CFR 814.122: Confidentiality of data and information.
  176. ema-valtropinValtropin
  177. Handling on the Scope of Situations where “Documents related to Clinical Study Results” is…
  178. William Hyman: The Promise and Challenge of UDI
  179. 21 CFR 1.240: What other registration requirements apply?
  180. ema-otulfiOtulfi
  181. Revlimid - Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of…
  182. Paediatric Committee (PDCO): 18-20 March 2015
  183. 21 CFR 1.79: Tobacco products.
  184. cdsco-golimumabGolimumab
  185. EU/3/22/2680 - orphan designation for treatment of nontuberculous mycobacterial lung…
  186. Conflicts of interest and confidentiality obligations
  187. Clinical investigation of plasma-derived antithrombin products - Scientific guideline
  188. Docetaxel Zentiva (previously Docetaxel Winthrop)
  189. IBERDOMIDE, DARATUMUMAB AND DEXAMETHASONE (IBERDD)
  190. ema-cepeloronCepeloron
  191. Lacosamide Pain UCB Pharma
  192. EU/3/16/1800 - orphan designation for treatment of Wolfram syndrome
  193. ema-neparvisNeparvis
  194. AS F0010.7.001: AO Critical Location Information Form
  195. cdsco-ca-170CA-170
  196. 21 CFR 886.1360: Visual field laser instrument.
  197. 2026.06.23 G.S.R. 509(E)_ Draft notification regarding simplification of the process for…
  198. EU/3/16/1618 - orphan designation for treatment of glioma
  199. Efonidipine Hydrochloride Ethanolate + Telmisartan IP uncoated bilayered tablets (Phase…
  200. ema-zercepacZercepac
  201. ema-ecazide-referralEcazide - referral
  202. ema-alunbrigAlunbrig
  203. Regulations for Reporting Serious Adverse Events of Medical Devices, Food and Drug…
  204. 21 CFR 868.1640: Helium gas analyzer.
  205. Byannli (previously Paliperidone Janssen-Cilag International)
  206. 21 CFR 880.5580: Acupuncture needle.
  207. Clinical efficacy and safety guidelines
  208. Rolling review for marketing authorisation applications
  209. Montelukast Sodium IP 10mg + Fexofenadine hydrochloride IP 180mg Uncoated bilayered tablet…
  210. EMEA-000835-PIP01-10 - paediatric investigation plan
  211. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17…
  212. Paediatric Committee (PDCO): 28-31 May 2024
  213. 23-valent Pneumococcal Polysaccharide Vaccine I.P.
  214. EU/3/08/589 - orphan designation for treatment of gastro-entero-pancreatic neuroendocrine…
  215. Pharm Research Associates (UK) Ltd withdraws marketing authorisation application for…
  216. 21 CFR 888.1500: Goniometer.
  217. Information for hospital blood banks during the coronavirus (COVID-19) outbreak
  218. 21 CFR 17.13: Notice of hearing.
  219. Committee for Medicinal Products for Human Use (CHMP): 6-9 November 2023
  220. IT systems unavailable from 15 to 18 June 2018
  221. Chapter 6 - Ingredient Guidance Northern Ireland
  222. Aranesp - withdrawal of application for variation to marketing authorisation
  223. PSUSA/00003143/202109 - periodic safety update report single assessment
  224. 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous…
  225. Annex A3 Guidance on Process Validation Scheme for Terminally Sterilised Products
  226. cdsco-vicadrostat-bi-690517Vicadrostat (BI 690517)
  227. China's Medical Device Standards Reach 1978 in Total
  228. 21 CFR 82.1327: D&C Red No. 27.
  229. PSUSA/00000608/202310 - periodic safety update report single assessment
  230. How to Pay Your Establishment Licence Fees
  231. PSUSA/00009084/202112 - periodic safety update report single assessment
  232. CEFEPIME-ZIDEBACTAM (FEP-ZID) WCK5222
  233. Quality of medicines questions and answers: Part 2
  234. International regulators pledge collective support to combat COVID-19 pandemic
  235. Evaluation of advanced therapy medicines
  236. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26…
  237. 21 CFR 876.5895: Ostomy irrigator.
  238. European Medicines Agency selects first two medicines to be included in its adaptive…
  239. cdsco-iptacopan-lnp023iptacopan (LNP023)
  240. Guide to In-Vitro Diagnostic Medical Devices Legislation
  241. PSUSA/00001506/202004 - periodic safety update report single assessment
  242. Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes: FDA…
  243. EMEA-001662-PIP03-17 - paediatric investigation plan
  244. 21 CFR 882.1880: Evoked response mechanical stimulator.
  245. European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 July 2006
  246. AAMI Recognizes Authors in Cloud Computing, Cybersecurity, and Smart Pumps
  247. Public notice on draft Recruitment rules for the post of LDC Central Drugs Laboratory…
  248. Principles for the Evaluation of Vaccines Against the Novel Coronavirus…
  249. Committee for veterinary medicinal products: 51st meeting
  250. Efficacy: multidisciplinary
  251. ema-avandametAvandamet
  252. Paediatric Committee (PDCO): 6-8 October 2010
  253. Repotrectinib ( BMS-986472,TPX-0005)
  254. EU/3/21/2422 - orphan designation for treatment of Dravet syndrome
  255. Refusal of orphan designation for treatment of poisoning by local anaesthetics
  256. Menarini International Operations Luxembourg withdraws its marketing authorisation…
  257. 2009 (H1N1) influenza pandemic
  258. 21 CFR 16.60: Hearing procedure.
  259. EMEA-001269-PIP01-12 - paediatric investigation plan
  260. EU/3/15/1470 - orphan designation for treatment of biliary tract cancer
  261. Committee for Orphan Medicinal Products (COMP): 5-7 December 2017
  262. Guideline on clinical investigation of medicinal products for the treatment of multiple…
  263. EMEA statement on the safety of Ketek
  264. EMEA-003032-PIP01-21-M01 - paediatric investigation plan
  265. Notice regarding PRO Veterinary Division 31 jan 2020
  266. EU/3/20/2329 - orphan designation for treatment of cholangiocarcinoma
  267. European Agency for the Evaluation of Medicinal Products: EudraLink Launch meeting 28-29…
  268. Suvorexant 20 mg Tablets
  269. 21 CFR 866.5060: Prealbumin immunological test system.
  270. European Union International Organization for Standardization (ISO) for the identification…
  271. ema-xareltoXarelto
  272. Increased fees coming into effect on 1 April 2014
  273. ema-ixinityIXinity
  274. EU/3/20/2306 - orphan designation for prevention of bronchopulmonary dysplasia
  275. Saphris (asenapine maleate) - Serious allergic reactions reported with the use of Saphris…
  276. Guide to Refusals and Appeals
  277. EU/3/22/2672 - orphan designation for treatment of osteosarcoma
  278. PSUSA/00002316/201908 - periodic safety update report single assessment
  279. ema-zioxtenzoZioxtenzo
  280. Circular: NOC for export of biological products (Vaccine & r-DNA products) under form 29…
  281. PSUSA/00002215/202204 - periodic safety update report single assessment
  282. 2022.01.13_Final GSR 14(E)_To amend rule 2 to substitute cell or stem cell derived product…
  283. Whole Virion, Inactivated Corona Virus Vaccine, Whole Virion, Inactivated Corona Virus…
  284. Repeal of wholesale dealer licence exemption for pharmacists
  285. 21 CFR 862.1250: Desoxycorticosterone test system.
  286. ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies
  287. Workshop on measuring the impact of pharmacovigilance activities
  288. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 November 2019
  289. Electromagnetic Compatibility Aspects of Medical Device Quality Systems
  290. Advanced therapy medicines: towards increased development and patient access
  291. Plasma Master File (PMF) submissions
  292. 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture.
  293. 21 CFR 880.6740: Vacuum-powered body fluid suction apparatus.
  294. Public notice on draft Recruitment rules for the post of Stenographer Grade-II in CDL…
  295. GN-12-2-R2 Guidance on Grouping-Specific (2022 Jan) PUB
  296. 21 CFR 872.2050: Dental sonography device.
  297. List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard…
  298. ema-sapropterin-dipharmaSapropterin Dipharma
  299. PSUSA/00002661/201907 - periodic safety update report single assessment
  300. Voices of HTM: Priyanka Upendra
  301. BA-BE Study Centre Approval Under New Drugs and CT Rules 2019
  302. cdsco-natalizumabNatalizumab
  303. EU/3/16/1790 - orphan designation for treatment of Huntington’s disease
  304. List of banned or restricted herbal ingredients for medicinal use
  305. cdsco-pf-07899801-rimegepantPF-07899801 (Rimegepant)
  306. 21 CFR 74.1706: FD&C Yellow No. 6.
  307. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21…
  308. Remogliflozin Etabonate + Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin Film…
  309. PSUSA/00001392/201908 - periodic safety update report single assessment
  310. EMEA-002967-PIP01-21 - paediatric investigation plan
  311. European Commission invites feedback on experience with the Paediatric Regulation
  312. EU/3/12/969 - orphan designation for treatment of acute myeloid leukaemia
  313. 21 CFR 882.1855: Electroencephalogram (EEG) telemetry system.
  314. cdsco-relugolix-tabletsRelugolix Tablets
  315. European Medicines Agency and US Food and Drug Administration set up biosimilar 'cluster'…
  316. Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)…
  317. ema-xeravaXerava
  318. Category lists following implementation of the Windsor Framework
  319. EMEA-001280-PIP01-12-M06 - paediatric investigation plan
  320. Ravulizumab 10mg/mL (300mg/ 30mL) or Placebo
  321. mhra-devices-made-by-silimedDevices made by Silimed
  322. European Medicines Agency adopts first positive opinion for a medicinal product derived…
  323. Don Armstrong: Be Like Mike
  324. How tests and testing kits for coronavirus (COVID-19) work: Target Product Profile: Point…
  325. Orphans: Regulatory and procedural guidance and forms
  326. European Medicines Agency/CHMP Working Group with Healthcare Professionals' Organisations…
  327. PSUSA/00001504/202304 - periodic safety update report single assessment
  328. EU/3/16/1759 - orphan designation for treatment of Duchenne muscular dystrophy
  329. Bed rails: management and safe use
  330. 21 CFR 870.3730: Pacemaker service tools.
  331. NMPA Issued the Notice on Enabling the New Version of the Drug Production License and…
  332. 21 CFR 864.7340: Fibrinogen determination system.
  333. Committee for Herbal Medicinal Products (HMPC): 20-22 September 2021
  334. Tredaptive, Pelzont and Trevaclyn - referral
  335. ema-dimethyl-fumarate-accordDimethyl fumarate Accord
  336. The evaluation of medicines, step-by-step
  337. EU/3/10/736 - orphan designation for treatment of argininosuccinic aciduria
  338. 21 CFR 878.5070: Air-handling apparatus for a surgical operating room.
  339. Eudravigilance stakeholders
  340. EMEA-002969-PIP01-21 - paediatric investigation plan
  341. EMEA-001220-PIP07-20-M01 - paediatric investigation plan
  342. UPDATE -- Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Software Update for…
  343. 21 CFR 866.2160: Coagulase plasma.
  344. Nuvolo Sponsors New AAMI BMET Apprenticeship Program
  345. 21 CFR 26.68: Withdrawal of listed conformity assessment bodies.
  346. Meeting highlights from the Committee for Medicinal Products for Human Use,16-19 February…
  347. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin…
  348. PSUSA/00010853/202111 - periodic safety update report single assessment
  349. Falsified Medicines Directive: Imported active substances need written confirmation to…
  350. PSUSA/00000210/202308 - periodic safety update report single assessment
  351. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June…
  352. 21 CFR 73.200: Synthetic iron oxide.
  353. European Communities (Medical Devices) (Amendment) (No 2) Regulations 2020 (SI 301/2020)…
  354. EU/3/14/1262 - orphan designation for prevention of bronchopulmonary dysplasia
  355. Corrigendum to the letter dated 11.04.2025 on manufacturing and marketing of unapproved…
  356. 21 CFR 892.1770: Diagnostic x-ray tube mount.
  357. Accelerating Clinical Trials in the EU (ACT EU): for better clinical trials that address…
  358. European Medicines Agency announces start of process improvement of core business…
  359. PSUSA/00010245/201803 - periodic safety update report single assessment
  360. cdsco-baricitinibBaricitinib
  361. EMEA-000087-PIP01-07-M05 - paediatric investigation plan
  362. Management Board meeting: 2 October 2014
  363. PSUSA/00002181/201801 - periodic safety update report single assessment
  364. EU/3/18/2016 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  365. PSUSA/00002910/201501 - periodic safety update report single assessment
  366. Live-Attenuated Respiratory Syncytial Virus (RSV) ∆NS2/∆1313/I1314L vaccine (RSVt…
  367. Notice Order regarding address the grievances appeals dated 22.06.2017
  368. Committee for Orphan Medicinal Products (COMP): 7-9 September 2021
  369. PSUSA/00010377/201904 - periodic safety update report single assessment
  370. EU/3/22/2713 - orphan designation for treatment of familial cerebral cavernous…
  371. AAMI 2024 Voting: Board Officers, Director, Nominating Committee Member, and Bylaws…
  372. PSUSA/00009084/201812 - periodic safety update report single assessment
  373. 21 CFR 872.3140: Resin applicator.
  374. EU/3/20/2319 - orphan designation for treatment of long-chain 3-hydroxyacyl-coenzyme A…
  375. Announcement of the National Medical Products Administration on Issuing Measures to…
  376. PSUSA/00001786/201910 - periodic safety update report single assessment
  377. PSUSA/00002656/201602 - periodic safety update report single assessment
  378. Voices of Cybersecurity: Michael C. McNeil
  379. PSUSA/00010288/201811 - periodic safety update report single assessment
  380. PSUSA/00000415/202208 - periodic safety update report single assessment
  381. CVS Consumer/Provider Surveys Show Continuing Role for Virtual and Digital Healthcare
  382. European Medicines Agency closed 5 June 2017
  383. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual live hands-on training…
  384. Third China domestic ECMO products approved for marketing
  385. EMEA-002233-PIP01-17-M02 - paediatric investigation plan
  386. PSUSA/00000462/201608 - periodic safety update report single assessment
  387. From Virtual Care to Virtual Reality: Mayo Clinic Manages Evolving Technologies
  388. EU/3/07/448 - orphan designation for treatment of renal-cell carcinoma
  389. Meeting of the EMEA working party on herbal medicinal products 31 May - 1 June 1999
  390. Prontax 5 mg/ml pour-on solution for cattle - referral
  391. Committee for Orphan Medicinal Products: November 2003 meeting
  392. How tests and testing kits for coronavirus (COVID-19) work: Target Product Profile: enzyme…
  393. C-TB, Tubercullin PPD RT23 SSI
  394. Mary Ann Drosnock: An Exciting Overhaul for ANSI/AAMI ST91
  395. EMEA-001053-PIP01-10-M03 - paediatric investigation plan
  396. 21 CFR 876.3: Effective dates of requirement for premarket approval.
  397. Janssen-Cilag International NV withdraws its marketing authorisation application for…
  398. Measles, Mumps and Rubella Vaccine (Live) I.P. (Freeze Dried)
  399. EU/3/20/2336 - orphan designation for treatment of primary IgA nephropathy
  400. 21 CFR 888.3027: Polymethylmethacrylate (PMMA) bone cement.
  401. Workshop: towards new treatments for tuberculosis
  402. PSUSA/00002460/201507 - periodic safety update report single assessment
  403. EMEA-001860-PIP03-16-M08 - paediatric investigation plan
  404. Policy on inspector orders for health products (POL-0139)
  405. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-22 May 2019
  406. ema-clopidogrel-ratiopharmClopidogrel ratiopharm
  407. Gazyvaro - withdrawal of application for variation to marketing authorisation
  408. PSUSA/00009084/201512 - periodic safety update report single assessment
  409. EU/3/18/2108 - orphan designation for treatment of congenital adrenal hyperplasia
  410. ema-symbioflor-2-referralSymbioflor 2 - referral
  411. EMEA-001653-PIP01-14-M02 - paediatric investigation plan
  412. Classification of Medical Device Pertaining to Dermatological and Plastic Surgery under…
  413. EMEA-001754-PIP01-15 - paediatric investigation plan
  414. Notice regarding Examination for safety and Efficacy of FDCs licensed for manufacture for…
  415. Metformin hydrochloride IP (as an extended-release form) + Sitagliptin Phosphate IP eq. to…
  416. AAMI Adopts ISO Radiation Sterilization Guidance
  417. ema-epidyolexEpidyolex
  418. Salim Kai: Be a Partner in Patient Safety
  419. 21 CFR 892.1910: Radiographic grid.
  420. EU/3/01/065 - orphan designation for treatment of multiple myeloma
  421. 21 CFR 890.5575: Powered external limb overload warning device.
  422. European Medicines Agency's Committee on Herbal Medicinal Products elects new chair and…
  423. ema-myclausenMyclausen
  424. EU/3/21/2517 - orphan designation for treatment of follicular lymphoma
  425. 21 CFR 866.3955: Human immunodeficiency virus (HIV) drug resistance genotyping assay using…
  426. 21 CFR 868.1920: Esophageal stethoscope with electrical conductors.
  427. New Source of Lead and Other Contamination
  428. 'Send a question' form working again
  429. EU/3/11/858 - orphan designation for treatment of fragile X syndrome
  430. Medicinal Products (Control of Manufacture) (Amendment) Regulations 2022 (SI 43/2022)…
  431. EU flags are up in EMA’s new building in Amsterdam
  432. EMEA-000673-PIP01-09-M09 - paediatric investigation plan
  433. ema-copalia-hctCopalia HCT
  434. Data requirements for changes to the strain composition of authorised equine influenza…
  435. EU/3/23/2800 - orphan designation for treatment of Leigh syndrome
  436. Ticagrelor product-specific bioequivalence guidance
  437. Guideline on clinical investigation of medicinal products in the treatment of lipid…
  438. 21 CFR 872.5571: Auto titration device for oral appliances.
  439. Investigation of drug interactions - Scientific guideline
  440. EMEA-002215-PIP01-17-M03 - paediatric investigation plan
  441. PSUSA/00010243/201510 - periodic safety update report single assessment
  442. Lixisenatid Subcutaneous
  443. EMEA-002151-PIP01-17 - paediatric investigation plan
  444. Collagen Scaffold for Cartilage Repair approved for marketing
  445. cdsco-tiotropiumTiotropium
  446. cdsco-tildrakizumabTildrakizumab
  447. cdsco-ct-p16CT-P16
  448. EU/3/09/642 - orphan designation for treatment of multiple myeloma
  449. Pegfilgrastim Injection 6mg (PFS)
  450. World Hypertension Day: 17 May 2013
  451. Medical devices: Standardised format for the post market surveillance report
  452. Paclitaxel-Carboplatin-Oregovomab)
  453. Nirsevimab solution for injection in prefilled syringe 50mg/ 100 mg (r-DNA origin)
  454. FDA Issues Draft Guidance on Considering Patient Perspectives on Medical Devices
  455. Ch. 3 - Commissioning and Information Sharing
  456. Management Board meeting: 15-16 December 2021
  457. Zolpidem-containing medicines - referral
  458. PSUSA/00001040/202207 - periodic safety update report single assessment
  459. ema-suprelorinSuprelorin
  460. EU/3/15/1595 - orphan designation for treatment of osteosarcoma
  461. Notice for inviting comment to ensure a level playing field in new drug approval in India
  462. EU/3/10/846 - orphan designation for treatment of oesophagus carcinoma
  463. Committee for Medicinal Products for Veterinary Use (CVMP): 2-4 June 2015
  464. EU/3/16/1626 - orphan designation for treatment of lymphoplasmacytic lymphoma
  465. EU/3/14/1331 - orphan designation for treatment of myelodysplastic syndromes
  466. 21 CFR 74.1340: FD&C Red No. 40.
  467. Cancer Medicines Forum: June 2023
  468. EU/3/21/2490 - orphan designation for treatment of lecithin-cholesterol acyltransferase…
  469. 21 CFR 74.2328: D&C Red No. 28.
  470. Regulations for Administration on Human Organ Bank, Regulations for Administration on…
  471. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - September 2016
  472. ema-lixianaLixiana
  473. Template for the qualified person's (QP) declaration concerning good manufacturing…
  474. EMEA-002875-PIP01-20 - paediatric investigation plan
  475. Goserelin Cell Pharm - referral
  476. cdsco-mino-lok-therapy-mltMino-Lok Therapy (MLT)
  477. ema-sildenafil-tevaSildenafil Teva
  478. cdsco-februric-febuxostatFebruric (Febuxostat)
  479. 21 CFR 803.56: If I am a manufacturer, in what circumstances must I submit a supplemental…
  480. PSUSA/00002661/202207 - periodic safety update report single assessment
  481. PSUSA/00003005/202003 - periodic safety update report single assessment
  482. Guideline on clinical investigation of medicinal products for treatment of rheumatoid…
  483. 21 CFR 864.7040: Adenosine triphosphate release assay.
  484. Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation…
  485. Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man…
  486. Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications
  487. April 18th 2018 GSR 381(E)
  488. PSUSA/00002944/201807 - periodic safety update report single assessment
  489. cdsco-iview-1201IVIEW-1201
  490. 21 CFR 862.1710: Total triiodothyronine test system.
  491. EU/3/22/2596 - orphan designation for treatment of Hypertrophic cardiomyopathy due to…
  492. EU/3/21/2436 - orphan designation for treatment of amyotrophic lateral sclerosis
  493. Letter to Associations Regarding Transfilling of Medical Gases
  494. 21 CFR 862.1373: Hemoglobin A1c test system.
  495. ema-xeljanzXeljanz
  496. EU/3/10/797 - orphan designation for treatment of amyotrophic lateral sclerosis
  497. Steam Sterilization Standard ST79 Receives Community-Driven Update
  498. PSUSA/00000426/202112 - periodic safety update report single assessment
  499. Committee for Advanced Therapies (CAT): 12-13 November 2015
  500. Adventitious agent safety of urine-derived medicinal products - Scientific guideline
  501. Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 February 2019
  502. ema-cevac-salmune-eti-kCevac Salmune ETI K
  503. Virtual live hands-on training course for clinical trials sponsors using EudraVigilance…
  504. EMEA-002360-PIP02-22-M01 - paediatric investigation plan
  505. EU/3/13/1120 - orphan designation for treatment of glioma
  506. EU/3/01/074 - orphan designation for treatment of systemic sclerosis
  507. Minnesota Living with Heart Failure Questionnaire (MLHFQ)
  508. MDR_G.S.R. 450(E) dt_15.06.2022_To amend Fourth Schedule wrt TSE or BSE certificate under…
  509. PSUSA/00002235/202008 - periodic safety update report single assessment
  510. Guide to Produce Farm Investigations (11/05)
  511. 21 CFR 876.1620: Urodynamics measurement system.
  512. Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 November 2014
  513. Clinical investigation of medicinal products for the treatment of sepsis - Scientific…
  514. EMEA-000145-PIP02-12-M05 - paediatric investigation plan
  515. ema-hbvaxproHBVaxPro
  516. PSUSA/00001693/202104 - periodic safety update report single assessment
  517. Committee for Orphan Medicinal Products (COMP): 11-13 July 2023
  518. Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
  519. PSUSA/00001844/201707 - periodic safety update report single assessment
  520. 2018.06.29_GSR 602(E)_Extention of implementation date for GSR 411(E) dated 27.04.2018
  521. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13…
  522. 21 CFR 812.43: Selecting investigators and monitors.
  523. EU/3/22/2643 - orphan designation for treatment of autoimmune haemolytic anaemia
  524. EMEA-002600-PIP03-21 - paediatric investigation plan
  525. Committee for medicinal products for veterinary use: Meeting of 11-13 September 2007
  526. 21 CFR 874.3820: Endolymphatic shunt.
  527. PSUSA/00000597/201601 - periodic safety update report single assessment
  528. 21 CFR 876.3630: Penile rigidity implant.
  529. Risk-mitigation measures related to the environmental risk assessment of veterinary…
  530. ACE scheme waiver guidance
  531. GN-32-R5 Guidance for Importation of Unregistered MD for Exhibition (2022 Sep) PUB
  532. EMEA-000007-PIP04-12 - paediatric investigation plan
  533. New Study Explores Borescope Inspections of Surgical Instrument Lumens
  534. SAMR Promulgates the Provisions for Drug Registration and Provisions for the Supervision…
  535. Lifecycle Cybersecurity and Working with Vendors
  536. European Medicines Agency seeking participants for website user-testing research
  537. ema-quality-guidelinesQuality guidelines
  538. Core summary of product characteristics for human varicella immunoglobulin for…
  539. EMEA-002106-PIP01-16-M02 - paediatric investigation plan
  540. cdsco-faricimab-6-mg-0-05-mlFaricimab, 6 mg/0.05 mL
  541. EMEA-002311-PIP01-17-M02 - paediatric investigation plan
  542. （In Japanese）Partial revision of the “Guidance for “Ministerial Ordinance on Good Clinical…
  543. EU/3/18/2125 - orphan designation for the treatment of sickle cell disease
  544. Chapter 5 - Presentation Guidance - Great Britain
  545. EMEA-001476-PIP01-13-M01 - paediatric investigation plan
  546. ICH S3B Pharmacokinetics: repeated dose tissue distribution studies - Scientific guideline
  547. cdsco-lnp1892LNP1892
  548. Preclinical pharmacological and toxicological testing of vaccines - Scientific guideline
  549. ema-cubicinCubicin
  550. EU/3/17/1969 - orphan designation for treatment of GM2 gangliosidosis
  551. Lidocaine Hydrochloride IP + Diltiazem Hydrochloride IP Gel (Phase III)
  552. ema-novaquinNovaquin
  553. ema-xiidraXiidra
  554. SPOR and xEVMPD Stakeholder Engagement Webinars : SPOR Data Governance
  555. Veterinary medicinal products for fluid therapy in case of diarrhoea - Scientific…
  556. Chemistry of active substances
  557. Surface coatings: general issues for consideration regarding parenteral administration of…
  558. Medroxyprogesterone Acetate SR tablet30 mg 30 mg Tablet
  559. EMEA-002455-PIP01-18 - paediatric investigation plan
  560. European Medicines Agency Human Scientific Committees' Working Party with Patients' and…
  561. ema-victozaVictoza
  562. Preliminary data indicate COVID-19 vaccines remain effective against severe disease and…
  563. Annex 17, Parametric Release (PIC/S) - Guide to Good Manufacturing Practice for Medicinal…
  564. cdsco-asciminibasciminib
  565. EMEA-000902-PIP01-10-M01 - paediatric investigation plan
  566. 21 CFR 12.20: Initiation of a hearing involving the issuance, amendment, or revocation of…
  567. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 July…
  568. 21 CFR 880.6150: Ultrasonic cleaner for medical instruments.
  569. ST91: Extensive Updates for Endoscope Cleaning, Patient Safety
  570. Committee for Advanced Therapies (CAT): 17-18 March 2021
  571. ema-flutiform-referralFlutiform - referral
  572. Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed), I.P. (15 valent
  573. Typhoid Vi conjugate Vaccine30sep
  574. 10 years of the Patients' and Consumers' Working Party
  575. Meeting of the EMEA working party on herbal medicinal products 29 and October 2001
  576. Expedited safety reporting requirements for clinical trials
  577. EU/3/11/916 - orphan designation for treatment of glioma
  578. cdsco-mifepristoneMifepristone
  579. AAMI Adopts ISO Guidance on Sterilization, Cardiovascular Devices, and More
  580. Problem with Quality of Mammograms at Coastal Diagnostic Center in Pismo Beach…
  581. Question and Answer Guide Regarding "Basic Principles on Electronic Submission of Study…
  582. ema-mipet-easectoMiPet Easecto
  583. cfr-21-cfr-808-1-scope21 CFR 808.1: Scope.
  584. EMEA-001109-PIP01-10 - paediatric investigation plan
  585. 21 CFR 874.3400: Tinnitus masker.
  586. insulin glargine 100 units/m
  587. AS P0017.004 Technical Review and Recognition Decision Procedure
  588. 21 CFR 73.1200: Synthetic iron oxide.
  589. 21 CFR 20.28: Food and Drug Administration determinations of confidentiality.
  590. Committee for Medicinal Products for Human Use (CHMP): 18-21 July 2011
  591. Committee for Herbal Medicinal Products (HMPC): 23-25 September 2019
  592. 21 CFR 862.1060: Delta-aminolevulinic acid test system.
  593. EU/3/15/1588 - orphan designation for treatment of gastro-entero-pancreatic neuroendocrine…
  594. Bill Saltzstein: 'Sweyntooth' Demystified
  595. FDA Drug Safety Communication: Update: Follow up to the Public Health Alert about Changes…
  596. Teva Pharma B.V. withdraws its marketing authorisation application for Clopidogrel Teva…
  597. 21 CFR 1.615: What records procedures must an accreditation body have to qualify for…
  598. EU/3/16/1641 - orphan designation for treatment of Leber's congenital amaurosis
  599. Antifibrinolytic medicines - referral
  600. EU/3/14/1429 - orphan designation for treatment of ovarian cancer
  601. EU/3/12/1028 - orphan designation for treatment of progressive familial intrahepatic…
  602. EU/3/22/2738 - orphan designation for treatment of carcinoid syndrome
  603. Denosumab (120 mg/1.7 mL)
  604. cdsco-sotagliflozinSotagliflozin
  605. EMEA-000506-PIP01-08-M02 - paediatric investigation plan
  606. Clinical investigation of medicinal products, including depot preparations in the…
  607. Dyax s.a. withdraws its marketing authorisation application for Kalbitor (ecallantide)
  608. 21 CFR 862.1395: 17-Hydroxyprogesterone test system.
  609. EU/3/24/2924 - orphan designation for treatment of DiGeorge syndrome
  610. 21 CFR 864.2800: Animal and human sera.
  611. Oxygen cylinders and their regulators: tips on how to handle them: Tips on care and…
  612. Suspect a serious adverse drug reaction or medical device incident (poster)
  613. Recommendation on the Qualification and Training of Inspectors in the Field of Human Blood…
  614. cdsco-bi-690517BI 690517
  615. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 February 2026
  616. QMS F0001.1.002 QMS Policy and Objectives
  617. PSUSA/00000996/202308 - periodic safety update report single assessment
  618. Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (r-DNA) and Haemophilus influenza…
  619. subcutaneous Secukinumab
  620. Dapagliflozin + Pioglitazone Hydrochloride IP eq. to Pioglitazone film coated tablets…
  621. ema-european-expertsEuropean experts
  622. cfr-21-cfr-25-1-purpose21 CFR 25.1: Purpose.
  623. PSUSA/00010239/201808 - periodic safety update report single assessment
  624. EMEA-003084-PIP03-22 - paediatric investigation plan
  625. 21 CFR 1.1103: Who is subject to this subpart?
  626. EU/3/14/1297 - orphan designation for treatment of haemophilia A
  627. ema-krystexxaKrystexxa
  628. ema-liprologLiprolog
  629. Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2026
  630. EMEA-000069-PIP05-16 - paediatric investigation plan
  631. EU/3/18/2077 - orphan designation for treatment of acute radiation syndrome
  632. 2019.10.16_S.O.3721 (E) Notification for Ultrasound equipment under 3b(iv) of D&C Act
  633. Sterility Assurance Levels and Aseptic Processing: An Introduction to Alternative SALs and…
  634. EU/3/06/401 - orphan designation for treatment of familial amyloid polyneuropathy
  635. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - May 2019
  636. Paediatric investigation plans
  637. EMEA-001845-PIP01-15 - paediatric investigation plan
  638. OTC Drug Monograph Implementation (PDF - 51KB)
  639. EMEA-000380-PIP06-19-M01 - paediatric investigation plan
  640. Committee for Advanced Therapies (CAT): 15-16 April 2014
  641. Committee for Advanced Therapies adopts five-year work programme to foster development of…
  642. PSUSA/00000394/202101 - periodic safety update report single assessment
  643. PSUSA/00002311/201705 - periodic safety update report single assessment
  644. DR_G.S.R. 169(E) dt_12.03.2001_26A_reg FDC of Diazepam and Diphenhydramine HCL
  645. cdsco-pantoprazolePANTOPRAZOLE
  646. Training on electronic submission of information on medicines - new pharmacovigilance…
  647. EMEA-002960-PIP02-21 - paediatric investigation plan
  648. Union Product Database: follow up webinar for marketing authorisation holders
  649. What’s in Store for the AAMI Board? A Conversation with Diane Wurzburger
  650. ema-omblastysOmblastys
  651. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  652. ema-ibandronic-acid-tevaIbandronic Acid Teva
  653. PSUSA/00002190/202306 - periodic safety update report single assessment
  654. Checklist for Device Risk Classification
  655. List of medical devices testing laboratory for carry out test or evaluation of medical…
  656. EU/3/04/238 - orphan designation for treatment of leprechaunism
  657. Notice regarding application were called for engagement of Research Scientist medical…
  658. Veterinary focus group meeting with stakeholders: revision of the reflection paper on…
  659. PSUSA/00010239/201508 - periodic safety update report single assessment
  660. 21 CFR 876.5310: Nonimplanted, peripheral electrical continence device.
  661. 2026.01.20 G.S.R. 45(E)_ Draft Notification for exemption of Animal Toxicity Studies…
  662. Medicines studied at Cetero Research facility - referral
  663. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August…
  664. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 June 2015
  665. Alcaftadine Nasal Spray ALDP001
  666. Pharmacovigilance procedures for human medicines
  667. EU/3/14/1298 - orphan designation for treatment of haemophilia B
  668. March 15-16, 2016: Circulatory System Devices Panel of the Medical Devices Advisory…
  669. Advice to sponsors on managing the impact of the war in Ukraine on clinical trials
  670. EU/3/19/2159 - orphan designation for treatment of acute myeloid leukaemia
  671. EU/3/18/1978 - orphan designation for treatment of glioma
  672. Committee for Advanced Therapies (CAT): 9-11 October 2019
  673. EU/3/15/1606 - orphan designation for treatment of soft tissue sarcoma
  674. FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns
  675. Notice regarding Implementation of e-Governance has launched an online protal SUGAM dated…
  676. Clinical investigation of the pharmacokinetics of therapeutic proteins - Scientific…
  677. cdsco-heptralHeptral
  678. ema-nobivac-myxo-rhdNobivac Myxo-RHD
  679. Haematology Working Party
  680. PSUSA/00010722/202207 - periodic safety update report single assessment
  681. EMEA-001741-PIP06-18 - paediatric investigation plan
  682. EU/3/18/2075 - orphan designation for treatment of Fanconi anaemia type A
  683. EMA welcomes EU Commissioner for Health and Food Safety
  684. Lifitegrast Opthalamic Solution 5%
  685. PSUSA/00002503/201804 - periodic safety update report single assessment
  686. AS P0034.002: Guidance for Regulatory Authority Assessors on the Method of Assessment for…
  687. 21 CFR 822.4: Does this part apply to me?
  688. Recommendation-NB-MED-2_5_4-2_rev3 Verification of Manufactured Products for the IVD…
  689. cdsco-noticeNotice
  690. Atorvastatin calcium - paediatric investigation plan
  691. ema-rasitrioRasitrio
  692. PSUSA/00000494/201806 - periodic safety update report single assessment
  693. ema-mvasiMvasi
  694. EMEA-000444-PIP01-08 - paediatric investigation plan
  695. EU/3/23/2882 - orphan designation for treatment of eosinophilic granulomatosis with…
  696. ema-idhifaIdhifa
  697. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  698. PSUSA/00010602/201803 - periodic safety update report single assessment
  699. Recommendations from the independent Expert Advisory Group on the use of Paclitaxel…
  700. Clinical investigation of hepatitis B immunoglobulins - Scientific guideline
  701. PSUSA/00000034/202309 - periodic safety update report single assessment
  702. NMPA Issued the Announcement on the Guidance for Medical Device Registrants to Conduct…
  703. Common issues identified during clinical trial applications: Useful Resources
  704. cdsco-sng001SNG001
  705. Use of tumorigenic cells of human origin for the production of biological and…
  706. 21 CFR 862.1675: Blood specimen collection device.
  707. ema-iI
  708. In Vivo Bioavailability-Bioequivalence Studies - Clinical
  709. European Medicines Agency Human Scientific Committee's Working Party with Healthcare…
  710. Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory…
  711. Register medical devices to place on the market
  712. Juice HACCP Inspection Program
  713. 21 CFR 26.37: Confidence building activities.
  714. European Medicines Agency: Committee for Medicinal Products for Human Use17-20 January…
  715. Notice Order regarding e-Governance project of CDSCO
  716. Inactivated poliomyelitis vaccine
  717. Regulatory information – A new operating model for procedure management to improve support…
  718. Big News Announced by The Joint Commission at AAMI eXchange
  719. UPDATED INFORMATION: April 12, 2023: Meeting of the Nonprescription Drugs Advisory…
  720. 21 CFR 20.88: Communications with State and local government officials.
  721. Taxotere - withdrawal of application for variation to marketing authorisation
  722. EMEA-002477-PIP01-18 - paediatric investigation plan
  723. 21 CFR 876.5025: Vibrator for climax control of premature ejaculation.
  724. PSUSA/00002208/201704 - periodic safety update report single assessment
  725. Update on the withdrawal of Thelin
  726. Pembrolizumab Injection 100 mg/4 mL (25 mg/mL) in a single vial (r-DNA origin)
  727. European medicines network designated as WHO listed authority
  728. Regulation 251 of the Human Medicines Regulations 2020: Notice concerning regulation 251
  729. EMEA-002312-PIP01-17-M01 - paediatric investigation plan
  730. 21 CFR 882.1471: Computerized cognitive assessment aid for concussion.
  731. Focus group with invited stakeholders on field efficacy trials in the context of an EU…
  732. MHRA guidance on the health institution exemption (HIE) - IVDR and MDR (Northern Ireland)
  733. Plecanatide Tablets 3 mg
  734. EMEA-002164-PIP01-17-M02 - paediatric investigation plan
  735. ema-isotretinoin-referralIsotretinoin - referral
  736. Notice Dated 17.09.2015 Format for MOU
  737. Template for notified body confirmation letter of the status of a formal application…
  738. EU/3/09/714 - orphan designation for treatment of congenital lymphatic malformations
  739. Gen Z in HTM: In Their Words
  740. PSUSA/00010078/202203 - periodic safety update report single assessment
  741. AAMI News, December 2019, Vol. 54, No. 12
  742. Suifertil 4-mg/ml oral solution for pigs and associated names - referral
  743. cfr-21-cfr-10-200-scope21 CFR 10.200: Scope.
  744. PSUSA/00001896/201411 - periodic safety update report single assessment
  745. PSUSA/00009236/201806 - periodic safety update report single assessment
  746. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course
  747. EMEA-000562-PIP01-09-M01 - paediatric investigation plan
  748. EU/3/16/1642 - orphan designation for treatment of epidermolysis bullosa
  749. 21 CFR 884.1175: Endometrial suction curette and accessories.
  750. EU/3/13/1229 - orphan designation for treatment of malignant mesothelioma
  751. PSUSA/00002192/202303 - periodic safety update report single assessment
  752. OTC medicine monograph: Dextromethorphan hydrobromide
  753. Paediatric Committee (PDCO): 24-27 March 2026
  754. December 3, 2025: Circulatory System Devices Panel Advisory Committee Meeting Announcement…
  755. Chapter 5 - Presentation Guidance Northern Ireland
  756. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15…
  757. 21 CFR 26.65: Designating authorities.
  758. Imnovid (previously Pomalidomide Celgene)
  759. EU/3/21/2435 - orphan designation for treatment of hyperphenylalaninemia
  760. Digital Dashboard Spurs Repair Time Renaissance for Health First HTM
  761. Notification of Mundra and Kamarajar Ports under Rule 43A, Draft GSR 1051(E)
  762. Safer Medicines in Pregnancy and Breastfeeding Consortium
  763. Rilvegostomig (AZD2936) Concentrate for solution for infusion 50 mg/mL (750 mg/vial)
  764. EMEA-002464-PIP01-18 - paediatric investigation plan
  765. ema-prevexxion-rn-hvtPrevexxion RN+HVT
  766. ema-dzuveoDzuveo
  767. Focus on Service and Repairs: Potential International HTM Standard Emerges
  768. Coagulation Factor VIII (Recombinant) rFVIII
  769. 21 CFR 820.120: Device labeling.
  770. UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of…
  771. Management Board: Meetings 2016
  772. Azilsartan Medoxomil + Amlodipine tablets (Phase III)
  773. AAMI Publications on Pediatric Telemetry, AI, Future of HTM Win Awards
  774. cdsco-ticagelorTicagelor
  775. Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety…
  776. cdsco-molnupiravir-moderate2Molnupiravir Moderate2
  777. Eucalypti aetheroleum - herbal medicinal product
  778. PSUSA/00001534/202206 - periodic safety update report single assessment
  779. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 June 2023
  780. PSUSA/000010330/202301 - periodic safety update report single assessment
  781. Second joint Drug Information Association/European Medicines Agency European Network of…
  782. 21 CFR 15.21: Notice of participation; schedule for hearing.
  783. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 December 2015
  784. Module for online processing of applications for registration of BA BE study centres…
  785. EMEA-000859-PIP01-10 - paediatric investigation plan
  786. BryKor LLC President Recognized With 2022 AAMI Award
  787. ema-nuceivaNuceiva
  788. PSUSA/00010145/201802 - periodic safety update report single assessment
  789. Bepotastine Besilate + Ketorolac Tromethamine IP + Benzalkonium Chloride IP (as…
  790. Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement…
  791. Blue Guide: advertising and promoting medicines: Appendix 2 - Blue Guide
  792. PSUSA/00000548/201910 - periodic safety update report single assessment
  793. Considering the Potential Impact of Data Bias on AI/ML and the Medical Device Ecosystem
  794. Restrictions on use of codeine for pain relief in children – CMDh endorses PRAC…
  795. cdsco-mdac-of-orthopedicMDAC of Orthopedic
  796. Biologicals: finished product
  797. ema-diovan-referralDiovan - referral
  798. Octreotide acetate product-specific bioequivalence guidance
  799. Virtual MRI Safety Evaluations of Medical Devices
  800. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 October 2011
  801. Ch. 9 - Import Operations and Actions
  802. SGLT2 inhibitors: information on potential risk of toe amputation to be included in…
  803. Clinical investigation of corticosteroids intended for use on the skin - Scientific…
  804. Stability testing for prescription medicines
  805. PSUSA/00010667/201806 - periodic safety update report single assessment
  806. DR_G.S.R. 144(E) dt_17.02.2017_Regulation of Oseltamivir Phosphate and Zanamivir
  807. 21 CFR 864.7400: Hemoglobin A2 assay.
  808. Post-authorisation measures: questions and answers
  809. EMEA-003227-PIP01-22 - paediatric investigation plan
  810. Oral Solutions and Suspensions (8/94)
  811. Human medicines: highlights of 2019
  812. Procedures for UK Paediatric Investigation Plan (PIPs)
  813. PSUSA/00010242/201708 - periodic safety update report single assessment
  814. 2025.03.27_S.O. 203(E)_Notification of Government Analysts at National Institute of…
  815. ema-neofordexNeofordex
  816. National AI Commission: Ask Me Anything
  817. cdsco-abelacimababeLacimab
  818. ema-versican-plus-piVersican Plus Pi
  819. ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on…
  820. Addressing Today’s HTM Talent Shortage, AAMI Members Reach the Next Generation
  821. Protherics withdraws its marketing authorisation application for Voraxaze
  822. PSUSA/00000430/202109 - periodic safety update report single assessment
  823. European Medicines Agency's Management Board supports plan to publish agendas and minutes…
  824. Naltrexone Hydrochloride + Zonisamide sustained release capsules (Phase II)
  825. European Medicines Agency (EMA) Joint Patients' and Consumers' (PCWP) and Healthcare…
  826. MEETING POSTPONED: March 22, 2018: Pediatric Advisory Committee and Endocrinologic and…
  827. EU/3/23/2779 - orphan designation for treatment of neurofibromatosis type 1
  828. ema-bylvayBylvay
  829. 2018-10-05_Draft GSR 999(E)_Upgradation of Sch M GMP
  830. Research Supports AEMs: AAMI Foundation Grant Recipient Shares Insights
  831. Similar biological medicinal products containing recombinant follicle-stimulating hormone…
  832. ema-xofigoXofigo
  833. Thirtieth meeting of the Management Board
  834. EMEA-000251-PIP01-08 - paediatric investigation plan
  835. HTM Team’s Tiered Huddles Drive Better Accountability at Medical Center
  836. EU/3/17/1896 - orphan designation for treatment of pachyonychia congenita
  837. PSUSA/00001388/202203 - periodic safety update report single assessment
  838. PSUSA/00002911/201510 - periodic safety update report single assessment
  839. HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS
  840. EMEA-001497-PIP01-13 - paediatric investigation plan
  841. PSUSA/00001562/201605 - periodic safety update report single assessment
  842. 21 CFR 866.5735: Prothrombin immunological test system.
  843. cdsco-linaclotideLinaclotide
  844. ema-lyxumiaLyxumia
  845. EU/3/16/1727 - orphan designation for treatment of acute radiation syndrome
  846. European Medicines Agency and European Healthcare Distribution Association (GIRP)…
  847. Takhzyro - opinion on variation to marketing authorisation
  848. Conduct of pharmacokinetic studies in target animal species - Scientific guideline
  849. Girolan and its associated name Apralan - referral
  850. ema-humiraHumira
  851. EU/3/14/1316 - orphan designation for treatment of haemophilia A
  852. Donna Marie Dyer: Women, See Yourself in HTM
  853. New Fee Regulation (from 1 January 2025)
  854. Rising to Cybersecurity’s Challenges with New Standard, AAMI SW96
  855. Committee for medicinal products for veterinary use: Meeting of 15-17 April 2008
  856. QMS P0004.003: Risk Management Procedure
  857. 21 CFR 866.3470: Reovirus serological reagents.
  858. Drug Alert list for month of April 2021
  859. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - March 2015
  860. Clinical investigation of medicinal products for the treatment of venous thromboembolic…
  861. Emtricitabine / rilpivirine / tenofovir disoproxil product-specific bioequivalence…
  862. 21 CFR 872.6030: Oral cavity abrasive polishing agent.
  863. Sugammadex Fresenius Kabi
  864. ema-librelaLibrela
  865. Quality: availability (limited markets)
  866. Additional manufacturing capacity for Moderna’s COVID-19 vaccine
  867. FDA approves Boxed Warning about increased risk of blood clots and death with higher dose…
  868. ema-zerbaxaZerbaxa
  869. PSUSA/00002921/201706 - periodic safety update report single assessment
  870. Etavopivat 200mg/ PlaceboM/s Novo Nordisk
  871. cdsco-osivelotorOsivelotor
  872. Public Notice regarding Promotion of Innovation Startup business in India in…
  873. ema-elmisolElmisol
  874. EU/3/23/2797 - orphan designation for treatment of osteosarcoma
  875. EMEA-000479-PIP01-08-M03 - paediatric investigation plan
  876. Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic…
  877. 21 CFR 870.2340: Electrocardiograph.
  878. Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
  879. Committee for Orphan Medicinal Products (COMP): 19-21 March 2019
  880. 21 CFR 868.2320: Uncompensated thorpe tube flowmeter.
  881. ICH M4E Common technical document for the registration of pharmaceuticals for human use…
  882. The European Union and the Food and Drug Administration working together to create common…
  883. ema-atacand-plus-referralAtacand Plus - referral
  884. Terpenic derivatives - referral
  885. cdsco-bococizumabBococizumab
  886. 21 CFR 886.1220: Corneal electrode.
  887. 2025.10.10_ G.S.R. 748(E)_Inclusion of Qualifications of Inspector Medical Devices and…
  888. EU/3/09/673 - orphan designation for treatment of Hodgkin's lymphoma
  889. Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
  890. Advice for producers of e-cigarette and vape products
  891. Seeking Harmony in Microbiological Quality Definitions
  892. Variations to prescription medicines - excluding variations requiring evaluation of…
  893. ema-etoricoxib-referralEtoricoxib - referral
  894. Refusal of orphan designation for treatment of autosomal dominant polycystic kidney…
  895. European Medicines Agency holds first meeting of expert group on the replacement…
  896. EMEA-001301-PIP01-12 - paediatric investigation plan
  897. Meeting highlights from the Paediatric Committee: 27-29 May 2009
  898. EMEA-002576-PIP01-19 - paediatric investigation plan
  899. Chapter 8 - Labelling Guidance Northern Ireland
  900. Regulation on the Permission, Notification, Review, Etc. of Medical Devices
  901. Testing a Medical Device Against 5G? FDA Will be ‘Flexible’ in Review
  902. 21 CFR 882.1560: Skin potential measurement device.
  903. 21 CFR 866.3355: Listeria spp. serological reagents.
  904. EMEA-002927-PIP02-21 - paediatric investigation plan
  905. Flucytosine - direct healthcare professional communication (DHPC)
  906. E-Submission Guide R2 for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC…
  907. Multidisciplinary: artificial intelligence (AI)
  908. Fixed combination products - Scientific guideline
  909. EU/3/13/1177 - orphan designation for treatment of pancreatic cancer
  910. 21 CFR 884.4050: Gynecologic laparoscopic power morcellation containment system.
  911. Regulations Governing Border Inspection and Examination of Imported Medical Devices
  912. ema-neuraceqNeuraceq
  913. cdsco-may-5-2014-g-s-r-310-eMay 5.2014 G.S.R. 310(E)
  914. PSUSA/00002151/202308 - periodic safety update report single assessment
  915. Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 (SI…
  916. 21 CFR 882.5300: Methyl methacrylate for cranioplasty.
  917. 21 CFR 882.4545: Shunt system implantation instrument.
  918. PSUSA/00000986/202009 - periodic safety update report single assessment
  919. Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety…
  920. 21 CFR 870.4290: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
  921. Amlodipine Besylate IP eq. to Amlodipine + Azilsartan Kamedoxomil eq. to Azilsartan…
  922. EU/3/18/2088 - orphan designation for treatment of Duchenne muscular dystrophy
  923. PSUSA/00001121/201710 - periodic safety update report single assessment
  924. 21 CFR 868.2300: Bourdon gauge flowmeter.
  925. Opening procedures at EMA to non-EU authorities (OPEN) initiative
  926. ema-brilenceBrilence
  927. European Medicines Agency recommends use of fibrates as second-line treatment
  928. EU/3/15/1585 - orphan designation for treatment of beta thalassaemia intermedia and major
  929. cdsco-nnc0487-0111-bNNC0487-0111 B
  930. GSK4057190A/Dostarlimab
  931. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 April 2022
  932. Why Japan for drug development Vol.2 (presentation for ENDPOINTS Events)
  933. 21 CFR 866.3330: Influenza virus serological reagents.
  934. Assessment and procurement of coronavirus (COVID-19) tests: COVID-19 test approval - step…
  935. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.9) Regulations…
  936. Azilsartan Medoxomil + Chlorthalidone (40mg+25mg,40mg+12.5mg 40mg+6.25mg) Tablets…
  937. Ethylene Oxide Sterilization 1. Calculation of Initial Gas Concentration
  938. PSUSA/00010929/202210 - periodic safety update report single assessment
  939. Classification of Medical Device Pertaining to Physical Support under the Provisions of…
  940. EMEA-001318-PIP01-12-M04 - paediatric investigation plan
  941. FDA Clears First New CT Technology in Nearly a Decade
  942. EU/3/19/2135 - orphan designation for treatment of DiGeorge syndrome
  943. cdsco-hrf-4467HRF-4467
  944. ema-secrefloSecreFlo
  945. Budesonide Sandoz - referral
  946. PSUSA/00010815/202007 - periodic safety update report single assessment
  947. Vortioxetine hydrobromide / vortioxetine lactate product-specific bioequivalence guidance
  948. Doxycycline related CNS Side Effects (Restlessness, Anxiety, Irritability, Nervousness…
  949. Cytopoint - opinion on variation to marketing authorisation
  950. ema-amaryl-referralAmaryl - referral
  951. EU/3/19/2140 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's…
  952. Credit card payment authorisation
  953. Screening Electronic Components
  954. EMA Management Board: highlights of October 2018 meeting
  955. ema-sivextroSivextro
  956. DR_G.S.R. 249(E) dt_04.04.2002_Amendment to Rule 3A_addition of NIB
  957. ema-suramox-referralSuramox - referral
  958. Medicines marketing authorisation: change of ownership
  959. Updated Status of Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication
  960. 21 CFR 862.1390: 5-Hydroxyindole acetic acid/serotonin test system.
  961. EMEA-002081-PIP01-16 - paediatric investigation plan
  962. CMDh endorses recommendations to restrict the use of diacerein-containing medicines
  963. Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 July 2022
  964. 21 CFR 888.3070: Thoracolumbosacral pedicle screw system.
  965. ema-levetiracetam-sunLevetiracetam Sun
  966. EU/3/22/2593 - orphan designation for treatment of phenylalanine hydroxylase deficiency
  967. Signal Management Review Technical (SMART) Working Group
  968. EMEA-000309-PIP09-21 - paediatric investigation plan
  969. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 June 2019
  970. Permission for conducting a clinical study entitled "A Phase-l/ll open label, single arm…
  971. European Medicines Agency publishes first weekly pandemic pharmacovigilance update
  972. European Medicines Agency recommends restricted use and strengthened warnings for Ketek
  973. PSUSA/00000039/202202 - periodic safety update report single assessment
  974. EU/3/22/2619 - orphan designation for treatment of idiopathic pulmonary fibrosis
  975. Telithromycin product-specific bioequivalence guidance
  976. EU/3/19/2174 - orphan designation for treatment of Duchenne muscular dystrophy
  977. EMEA-000824-PIP01-09 - paediatric investigation plan
  978. EU/3/22/2614 - orphan designation for treatment of myopathic mitochondrial DNA depletion…
  979. ema-leflunomide-medacLeflunomide medac
  980. European Medicines Agency publishes interim fee advice for bluetongue-vaccine…
  981. Focus on Service and Repairs: HTM Educators, Students Adapt to Displacement in a COVID-19…
  982. ema-ema-relocation-updatesEMA relocation updates
  983. EU/3/23/2847 - orphan designation for treatment of CSF1R-related leukoencephalopathy
  984. Sampling for Foodborne Biological Hazards, and Filth - Domestic and Import
  985. EU/3/19/2175 - orphan designation for treatment of glycogen storage disease type II…
  986. EMEA-002111-PIP02-17 - paediatric investigation plan
  987. P/0343/2014 - paediatric investigation plan
  988. European Medicines Agency Management Board re-elects Sir Kent Woods as chair
  989. Synapse Labs Pvt. Ltd: EMA recommends suspension of medicines over flawed studies
  990. Millefolii herba - herbal medicinal product
  991. PSUSA/00000789/201906 - periodic safety update report single assessment
  992. PSUSA/00002160/201908 - periodic safety update report single assessment
  993. HRF-10071 and Dolutegravir
  994. PSUSA/00000082/202109 - periodic safety update report single assessment
  995. AAMI Seeks 2023 Nominations for Awards Programs
  996. EU/3/04/236 - orphan designation for treatment of type A extreme insulin resistance…
  997. Basic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global…

About this dataset

Regulations, guidance and official notices from medical device and medicines regulators worldwide, collected by Orca1 from each issuer's website. Only the title, issuer, date and link are shown here; the full text is searchable in Orca1.

Source: Medical device and medicines regulators and agencies as named on each record (EMA, MHRA, TGA, CDSCO, PMDA, NMPA, Health Canada, HSA, the FDA and others), collected by Orca1 from each issuer's website