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Global regulations and guidance

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

  1. ICH M4E Common technical document for the registration of pharmaceuticals for human use…
  2. Public hearing on 13 June 2018
  3. Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T…
  4. Application for Partial Changes Based on Evaluation of Applicability to Drug-agnostic…
  5. Narrowed Indications for Use for the Stryker Wingspan Stent System: FDA Safety…
  6. Xalkori - direct healthcare professional communication (DHPC)
  7. cdsco-spi-2012SPI-2012
  8. cdsco-parenteral-tk-112690Parenteral TK-112690
  9. Clinical Trials Information System (CTIS): Walk-in clinic - August 2022
  10. 21 CFR 862.1645: Urinary protein or albumin (nonquantitative) test system.
  11. 21 CFR 74.2203: FD&C Green No. 3.
  12. EU/3/21/2473 - orphan designation for treatment of SLC13A5-epileptic encephalopathy…
  13. Voices of HTM: Karen Waninger
  14. 21 CFR 82.1307: D&C Red No. 7.
  15. ema-kanumaKanuma
  16. PSUSA/00002781/202401 - periodic safety update report single assessment
  17. ema-vepesid-referralVepesid - referral
  18. EMEA-002195-PIP01-17 - paediatric investigation plan
  19. EU/3/12/972 - orphan designation for treatment of GNE myopathy
  20. 21 CFR 866.3050: Beta-glucan serological assays.
  21. Committee for Medicinal Products for Human Use (CHMP): 19-22 May 2025
  22. 21 CFR 878.4680: Nonpowered, single patient, portable suction apparatus.
  23. cdsco-ataciceptAtacicept
  24. EMEA-001523-PIP04-19-M02 - paediatric investigation plan
  25. PSUSA/00001629/202105 - periodic safety update report single assessment
  26. 21 CFR 868.5530: Flexible laryngoscope.
  27. Pharmacovigilance Risk Assessment Committee (PRAC): 31 July - 3 August 2023
  28. Draft guideline on biosimilar medicines containing monoclonal antibodies released for…
  29. How to make better use of patient registries to collect high-quality data on medicines
  30. cdsco-doxazosin-tablet-2-mgDoxazosin Tablet 2 mg
  31. ema-eurican-herpes-205Eurican Herpes 205
  32. cdsco-20172017
  33. ema-ioaIoa
  34. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-19 June…
  35. VICH GL58 stability testing of new veterinary drug substances and medicinal products in…
  36. European Medicines Agency reviews its operations and prepares for reorganisation in 2013
  37. 11th stakeholder forum on the pharmacovigilance legislation
  38. Ursodiol Injection 625 mg/25ml (25mg/ml
  39. Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors…
  40. Management Board meeting: 16-17 March 2022
  41. PSUSA/00000928/202012 - periodic safety update report single assessment
  42. 21 CFR 868.5180: Rocking bed.
  43. Committee for Medicinal Products for Human Use (CHMP): 16-19 August 2022
  44. Chapter 2 - Product Type Guidance Northern Ireland: Chapter 2 - Product Type Guidance - NI
  45. Evenamide(NW-3509/008/II/2019)
  46. 21 CFR 862.1040: Aldolase test system.
  47. AAMI eXchange 2023: Your Guide to Prepare
  48. 21 CFR 7.59: General industry guidance.
  49. EU/3/07/509 - orphan designation for treatment of acute myeloid leukaemia
  50. EMEA-003168-PIP01-21 - paediatric investigation plan
  51. EU/3/18/1983 - orphan designation for treatment of pyridoxamine 5'-phosphate oxidase…
  52. Committee on herbal medicinal products: Elects new chair and vice-chair
  53. Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices)…
  54. New Boots on the Ground Revolutionize Hospital Equipment Management
  55. EMA launches new corporate website
  56. PSUSA/00000051/201810 - periodic safety update report single assessment
  57. EU/3/17/1930 - orphan designation for treatment of primary biliary cholangitis
  58. Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be…
  59. PSUSA/00001266/202108 - periodic safety update report single assessment
  60. PSUSA/00000073/202007 - periodic safety update report single assessment
  61. Therapeutic goods advertising and ASX announcements
  62. Variations not requiring assessment (veterinary medicines)
  63. cdsco-zetomipzomib-kzr-616Zetomipzomib (KZR-616)
  64. Quarterly system demo - Q2 2023
  65. 21 CFR 1.382: What labeling or marking requirements apply to a detained article of food?
  66. Draft Health Canada IMDRF table of contents for medical device applications guidance
  67. Measures to help protect patients from falsified medicines
  68. European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic…
  69. ema-scenesseScenesse
  70. ema-opzeluraOpzelura
  71. ema-rebifRebif
  72. EU/3/13/1205 - orphan designation for treatment of eosinophilic oesophagitis
  73. EU/3/22/2625 - orphan designation for treatment of hereditary angioedema
  74. Althaeae radix - herbal medicinal product
  75. New legislation for veterinary medicines
  76. European Immunization Week 2018: Statement of Guido Rasi, Executive Director, European…
  77. 21 CFR 890.5350: Exercise component.
  78. cdsco-enterogerminaEnterogermina
  79. EU/3/06/351 - orphan designation for treatment of Niemann-Pick's disease, type C
  80. Regulatory information - adjusted fees for applications to European Medicines Agency from…
  81. Public webinar on pack size submissions: from XEVMPD to product management service (PMS)
  82. Evaluation of 16 Fixed Dose Combinations (FDCs) by DTAB Sub-Committee which were earlier…
  83. EMEA-000770-PIP02-11 - paediatric investigation plan
  84. Basic Principles on Japanese Clinical Trial Data for Drugs for Rare Diseases, etc., for…
  85. PSUSA/00002643/202108 - periodic safety update report single assessment
  86. With HTM, "I Can Make a Difference”
  87. Committee for Medicinal Products for Human Use (CHMP): 25-28 April 2016
  88. PSUSA/00009004/201707 - periodic safety update report single assessment
  89. EU/3/03/160 - orphan designation for treatment of retinopathy of prematurity
  90. World Cancer Day: 4 February 2011
  91. 21 CFR 884.2990: Breast lesion documentation system.
  92. cdsco-bay-94-8862-finerenoneBAY 94-8862 / Finerenone
  93. 21 CFR 888.3025: Passive tendon prosthesis.
  94. Environmental risk assessment for parasiticide veterinary medicinal products used in…
  95. PSUSA/00000430/201609 - periodic safety update report single assessment
  96. Increase in manufacturing capacity for Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
  97. EU/3/12/1023 - orphan designation for treatment of Barraquer-Simons syndrome
  98. Iodocasein- and thiamine-containing medicinal products - referral
  99. Halfway Across the World, an Engineer Finds His HTM Calling
  100. EMEA-001623-PIP03-20-M01 - paediatric investigation plan
  101. 21 CFR 13.45: Examination of administrative record.
  102. ema-zeritZerit
  103. 21 CFR 10.20: Submission of documents to Division of Dockets Management; computation of…
  104. Handling of clinical study data on medical devices which was carried out in foreign…
  105. PSUSA/00002433/201510 - periodic safety update report single assessment
  106. Transatlantic Taskforce on Antimicrobial Resistance reports progress and outcomes of 17…
  107. Clinical investigation of medicinal products for the treatment of acute heart failure…
  108. EU/3/22/2711 - orphan designation for treatment of Menkes disease
  109. 2021.10.12_Draft GSR 729(E)_Amendment in rules 19B, 19C,19D &19E of MDR 2017
  110. ema-oncasparOncaspar
  111. 21 CFR 12.37: Effective date of a regulation.
  112. cdsco-ldk378LDK378
  113. Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability of…
  114. EMEA-001758-PIP01-15-M02 - paediatric investigation plan
  115. Regulatory update - EMA encourages companies to submit type-I variations for 2014 by end…
  116. Register of authorised online sellers of medicines in Northern Ireland
  117. SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day…
  118. Guide to Fees for Human Products
  119. Spikevax (previously COVID-19 Vaccine Moderna) - direct healthcare professional…
  120. PSUSA/00009319/201708 - periodic safety update report single assessment
  121. cfr-21-cfr-73-1329-guanine21 CFR 73.1329: Guanine.
  122. 21 CFR 890.5730: Moist heat pack.
  123. G.S.R 46(E) dated 22.01.2009 Drugs and Cosmetics First Amendment Rules 2009
  124. GN-20-R2 Guidance on Clinical Evaluation(2022 Nov)_PUB [PDF, 444 KB]
  125. PSUSA/00010532/202009 - periodic safety update report single assessment
  126. World Heart Day: 29 September 2011
  127. ema-mayzentMayzent
  128. EMEA-001407-PIP03-20 - paediatric investigation plan
  129. National competent authorities (human)
  130. 21 CFR 888.3520: Knee joint femorotibial metal/polymer non-constrained cemented…
  131. Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting…
  132. Conference on: Environmental Risk Assessment for Human and Veterinary Medicinal Products
  133. DR_G.S.R. 422(E) GSR 423(E) dt_11.06.2002_Rule 168& First Scedule
  134. Core summary of product characteristics for human normal immunoglobulin for intravenous…
  135. Bristol-Myers Squibb Pharma EEIG withdraws its marketing authorisation application for…
  136. DOC version - 136 KB
  137. 21 CFR 868.1840: Diagnostic spirometer.
  138. EMEA-002514-PIP01-18 - paediatric investigation plan
  139. P/0451/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver…
  140. EU/3/14/1334 - orphan designation for treatment of fragile X syndrome
  141. Clinical investigation of medicinal products in the treatment of Parkinson's disease…
  142. Inclusion of appendices to clinical study reports in marketing authorisation applications…
  143. EMEA-003309-PIP01-22 - paediatric investigation plan
  144. Committee for veterinary medicinal products: 37th meeting
  145. 21 CFR 1.632: What is the duration of recognition?
  146. European Antibiotic Awareness Day: Fighting the silent pandemic
  147. Clinical Trials Information System (CTIS): Walk-in clinic - July 2024
  148. Fibrinogen-containing solutions for sealant authorised for administration by spray…
  149. Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in…
  150. Dose review and adjustment of established veterinary antibiotics in the context summary of…
  151. Sitagliptin Phosphate IP eq. to Sitagliptin + Pioglitazone Hydrochloride IP eq. to…
  152. EU/3/09/676 - orphan designation for treatment of haemophilia B
  153. EMEA announces new CPMP chairman and vice-chairman
  154. 21 CFR 862.1655: Pyruvic acid test system.
  155. New validation criteria for electronic submissions from 1 September 2011
  156. Western Pharmaceuticals Good Distribution Practice Regulations
  157. PSUSA/00010346/201611 - periodic safety update report single assessment
  158. Checklist for Form MD-14 IVD (Application for issue of import licence to import medical…
  159. Introducing AAMI neXus, the Evolved International Standards Conference
  160. 21 CFR 862.1670: Sorbitol dehydrogenase test system.
  161. BP05 Versus EU-Approved Lucentis®
  162. Chantix - Chantix (varenicline) may increase the risk of certain cardiovascular adverse…
  163. 21 CFR 868.5320: Reservoir bag.
  164. PSUSA/00002269/201805 - periodic safety update report single assessment
  165. EU/3/13/1221 - orphan designation for treatment of haemophilia A
  166. Voices of Cybersecurity: Cory Brennan
  167. DR_G.S.R. 289(E) dt_15.04.2015_Amendment Rule 74,74A,74B, 78,78A_No Advertisement for Sch…
  168. Clinical development of medicinal products for the treatment of cystic fibrosis…
  169. United Airlines Introduces Telehealth-Observed COVID Self Testing
  170. Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs
  171. PSUSA/00010266/201612 - periodic safety update report single assessment
  172. PSUSA/00001350/201709 - periodic safety update report single assessment
  173. NMPA Issues the Writing Specification for Periodic Risk Evaluation Reports of Medical…
  174. ema-unituxinUnituxin
  175. EMA supports pilot for joint African continental assessment procedures
  176. Scientific guidance on post-authorisation efficacy studies - Scientific guideline
  177. EU/3/06/380 - orphan designation for treatment of alopecia universalis
  178. Industry annual bilateral meetings
  179. Clinical Trials Information System (CTIS) sponsor end user training programme - April 2024
  180. EU/3/18/2101 - orphan designation for treatment of leptin receptor deficiency
  181. Third industry stakeholder platform on the operation of the centralised procedure for…
  182. Adempas not for use in patients with pulmonary hypertension caused by idiopathic…
  183. Secure Your Legacy Devices—Or Else!
  184. AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual…
  185. 21 CFR 866.3660: Shigella spp. serological reagents.
  186. Committee for Medicinal Products for Human Use (CHMP): 19-22 May 2014
  187. ema-tyverbTyverb
  188. Generic and hybrid medicines
  189. The Gains and Pains of Digital Health
  190. cdsco-tapentadol-hyTapentadol Hy
  191. PSUSA/00010092/202104 - periodic safety update report single assessment
  192. Carol Herman: Get Ready for Standards Week
  193. Asthma long-acting ß2 agonists: use and safety
  194. PSUSA/00001990/202202 - periodic safety update report single assessment
  195. European network of paediatric research at the European Medicines Agency (Enpr-EMA)…
  196. Septanest and associated names - referral
  197. EU/3/13/1151 - orphan designation for treatment of malignant thymoma
  198. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  199. 21 CFR 73.1025: Ferric ammonium citrate.
  200. Cefpodoxime Proxetil 200/400 mgTablet
  201. cdsco-phesgoPHESGO
  202. EMA workshop on thrombosis with thrombocytopenia syndrome
  203. 21 CFR 870.2900: Patient transducer and electrode cable (including connector).
  204. Eviplera - withdrawal of application for variation to marketing authorisation
  205. Towards improving the availability of medicines in the EU
  206. Cellular, Tissue, and Gene Therapies Advisory Committee July 29, 2026 Meeting Announcement…
  207. EU/3/14/1282 - orphan designation for treatment of Usher syndrome
  208. Intracranial Aneurysm Embolization Assist Stent Approved for Marketing
  209. Lynparza - opinion on variation to marketing authorisation
  210. FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol…
  211. Coronary Function Measurement System Approved for Marketing
  212. cdsco-dapagliflozinDapagliflozin
  213. 21 CFR 892.1300: Nuclear rectilinear scanner.
  214. STATE NSQ ALERT FOR THE MONTH OF July-2024
  215. European Antibiotic Awareness Day: 18 November 2010
  216. EMEA-000060-PIP02-08-M06 - paediatric investigation plan
  217. cdsco-azd4604AZD4604
  218. PSUSA/00001151/201803 - periodic safety update report single assessment
  219. Drospirenone / ethinylestradiol bethadex clathrate - paediatric investigation plan
  220. nbcg-survey-2020Survey-2020
  221. EMEA-000301-PIP01-08-M03 - paediatric investigation plan
  222. PIC/S GMP Guide (PE 009-17) Annexes
  223. Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multistakeholder…
  224. EMEA-002612-PIP02-22 - paediatric investigation plan
  225. Notification Concerning Partial Amendment of the Ministerial Ordinance on Standards for…
  226. tga-guidance-for-tgo-101Guidance for TGO 101
  227. 2026.04.21 G.S.R. 299(E)_ Draft Notification for amendment under Rule 89 of Drugs Rules…
  228. Ritonavir Viatris (previously Ritonavir Mylan)
  229. EU/3/17/1865 - orphan designation for treatment of neonatal encephalopathy
  230. cdsco-asciminibAsciminib
  231. PSUSA/00010223/201702 - periodic safety update report single assessment
  232. DOC version - 134 KB
  233. cdsco-vpm1002-rbcg-vaccineVPM1002 (rBCG) Vaccine
  234. New treatment for young children with parasitic disease schistosomiasis
  235. November 17, 2023: Meeting of the Pulmonary-Allergy Drugs Advisory Committee - 11/17/2023
  236. Medicines: register as a broker
  237. EMEA-002665-PIP02-20 - paediatric investigation plan
  238. Ralph Basile Appointed to Philanthropic Activities for the AAMI Foundation
  239. EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary…
  240. EU/3/18/2070 - orphan designation for treatment of dermatomyositis
  241. Codeine not to be used in children below 12 years for cough and cold
  242. cdsco-prolectin-mProlectin M
  243. Paediatric Committee (PDCO): 21-23 May 2014
  244. Regulatory harmonisation of clinical trials in the EU: Clinical Trials Regulation to enter…
  245. SPOR and xEVMPD Stakeholder Engagement Webinars : EMA Account Management
  246. ema-sohonosSohonos
  247. It’s Not Your Father's HTM... Unless Your Mentor is Your Father ​
  248. Committee for Advanced Therapies (CAT): 15-17 July 2020
  249. PSUSA/00000109/202203 - periodic safety update report single assessment
  250. ema-baycox-ironBaycox Iron
  251. Q&A on the Master File (MF) System, Part III
  252. EMEA-000428-PIP01-08-M03 - paediatric investigation plan
  253. PSUSA/00001796/201508 - periodic safety update report single assessment
  254. ema-benefixBeneFIX
  255. EU/3/12/1071 - orphan designation for treatment of…
  256. 21 CFR 870.4360: Nonroller-type blood pump.
  257. EU/3/18/2029 - orphan designation for treatment of tuberculosis
  258. Vaccines and Related Biological Products Advisory Committee October 10, 2024 Meeting…
  259. PSUSA/00000883/201702 - periodic safety update report single assessment
  260. Guidance for completing an application for consent to import, supply, or export a medical…
  261. European Medicines Agency to accept biosimilar reference medicines sourced outside…
  262. MHRA fees: MHRA fees definitions
  263. 21 CFR 74.1330: D&C Red No. 30.
  264. ema-zemfirzaZemfirza
  265. Committee for Medicinal Products for Human Use (CHMP): 22-25 January 2024
  266. ema-alpivabAlpivab
  267. cdsco-basimglurantBasimglurant
  268. Faldaprevir Boehringer Ingelheim
  269. ema-ibuprofen-gen-orphIbuprofen Gen.Orph
  270. 3Rs Working Party (3RsWP) plenary meeting – Public session on the 2024 work plan
  271. Provisions for Supervision of Drug Distribution
  272. 21 CFR 882.1610: Alpha monitor.
  273. PSUSA/00001596/202401 - periodic safety update report single assessment
  274. May 18, 2023: Tobacco Products Scientific Advisory Committee Meeting - 05/18/2023
  275. PSUSA/00010209/201602 - periodic safety update report single assessment
  276. Investigational product repackaging on site
  277. Triafarotene 50 µg/g Cream
  278. PSUSA/00002131/202203 - periodic safety update report single assessment
  279. cdsco-molnupiravir-mildrMolnupiravir Mildr
  280. cdsco-etrasimodEtrasimod
  281. cdsco-abrocitinibAbrocitinib
  282. FDA Issues Final Guidance on UDI Form and Content
  283. 2022.03.04_Final GSR 174(E)_Amendment of rule 36(3) MDR to include United Kingdom under…
  284. EU/3/17/1863 - orphan designation for treatment of multiple myeloma
  285. EU/3/15/1472 - orphan designation for diagnosis of glioma
  286. EU/3/03/173 - orphan designation for treatment of pulmonary arterial hypertension and…
  287. EMEA-002428-PIP02-18 - paediatric investigation plan
  288. SARS-CoV-2 (Covid-19) Vaccine
  289. EU/3/08/608 - orphan designation for treatment of pancreatic cancer
  290. EU/3/21/2471 - orphan designation for treatment of multiple myeloma
  291. Weather Related Power Outages Are Increasing, Posing Risk to Patients Using Electronic…
  292. ema-vectibixVectibix
  293. Committee for Advanced Therapies (CAT): 19-20 February 2015
  294. Compliance Monitor (CM) Overview and Application Process
  295. ema-yuflymaYuflyma
  296. Committee for Herbal Medicinal Products (HMPC): 24-26 January 2022
  297. EMEA-002876-PIP01-20 - paediatric investigation plan
  298. EMEA-002047-PIP01-16 - paediatric investigation plan
  299. Committee for Orphan Medicinal Products (COMP): 6-8 September 2022
  300. EU/3/13/1124 - orphan designation for treatment of Niemann-Pick's disease, type C
  301. European Medicines Agency welcomes adoption of new pharmacovigilance legislation by…
  302. Certification of medicinal products
  303. ema-ordsponoOrdspono
  304. Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA…
  305. Procedural guidance to help pharma companies prepare for Brexit
  306. EU/3/12/993 - orphan designation for treatment of neurofibromatosis type 2
  307. Electronic product information for human medicines in the European Union – key principles
  308. 21 CFR 878.3550: Chin prosthesis.
  309. EMEA-001529-PIP02-14-M03 - paediatric investigation plan
  310. cfr-21-cfr-17-5-complaint21 CFR 17.5: Complaint.
  311. EMEA-002263-PIP01-17 - paediatric investigation plan
  312. Webinar on the draft Data Quality Framework for EU medicines regulation
  313. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6…
  314. EMEA-002058-PIP01-16-M01 - paediatric investigation plan
  315. 2022.11.17_Final GSR 823(E)_Amendment in rule 96 for mandating Bar or QR code on the label…
  316. 21 CFR 872.1905: Dental x-ray film holder.
  317. PSUSA/00000171/201802 - periodic safety update report single assessment
  318. 13th meeting of the committee for veterinary medicinal products
  319. EMEA-000139-PIP01-07-M03 - paediatric investigation plan
  320. System or procedure packs
  321. Dapagliflozin IP +Metformin Hydrochloride IP (as sustained release) + Sitagliptin…
  322. ema-osigraftOsigraft
  323. First information day on the use of the Medical Dictionary for Regulatory Activities…
  324. ema-hetliozHetlioz
  325. ‘Daddy’s Machine’: HTM Professional Services Son’s Radiation Therapy Device
  326. Former EMA policy on minor use / minor species (MUMS) / limited markets
  327. 21 CFR 20.23: Request for existing records.
  328. EU/3/18/2022 - orphan designation for treatment of congenital hyperinsulinism
  329. PSUSA/00010484/201705 - periodic safety update report single assessment
  330. 21 CFR 864.7925: Partial thromboplastin time tests.
  331. Order M/s united Distributors Incoporation
  332. Pitch Your Innovative Digital Health Solutions at AAMI Xcelerator 2020
  333. ema-rinvoqRinvoq
  334. EMEA-002664-PIP01-19 - paediatric investigation plan
  335. EU/3/21/2468 - orphan designation for treatment of non-traumatic spontaneous intracerebral…
  336. 21 CFR 866.1620: Antimicrobial susceptibility test disc.
  337. PSUSA/00002849/201711 - periodic safety update report single assessment
  338. 2021.12.31_Final GSR 918(E)_Amendment of rnule 46 of MDR for Unique Device Identification
  339. Remogliflozin Etabonate Vildagliptin film coated tablet
  340. Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of…
  341. ICH S1A Need for carcinogenicity studies of pharmaceuticals - Scientific guideline
  342. ema-megestrol-alkermesMegestrol Alkermes
  343. 21 CFR 70.40: Safety factors to be considered.
  344. ema-compassionate-useCompassionate use
  345. First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic…
  346. 21 CFR 868.5273: Positive airway pressure delivery system.
  347. EMEA-001397-PIP03-14-M06 - paediatric investigation plan
  348. 21 CFR 866.3305: Herpes simplex virus serological assays.
  349. Suvorexant Tablets 10 mg, 15mg and 20mg
  350. EU/3/10/799 - orphan designation for treatment of cowpox infection
  351. Committee for Advanced Therapies (CAT): 16-17 September 2010
  352. ema-possiaPossia
  353. FDA Seeks 510(k) Overhaul with Three New Guidance Documents
  354. Core summary of product characteristics for human plasma-derived hepatitis B…
  355. Considerations for the inclusion of adolescent patients in adult oncology clinical trials…
  356. PSUSA/00001854/201510 - periodic safety update report single assessment
  357. 21 CFR 74.2706: FD&C Yellow No. 6.
  358. EU/3/16/1752 - orphan designation for treatment of haemophilia A
  359. 2025.08.18_G.S.R. 554(E)_Inclusion of details of excipient on every strip of medicines…
  360. ema-palonosetron-accordPalonosetron Accord
  361. 21 CFR 1.405: When does FDA have to issue a decision on an appeal?
  362. Standardised units of measurement for veterinary antimicrobials
  363. Fentanyl citrate - paediatric investigation plan
  364. Paediatric Committee (PDCO): 13-15 August 2014
  365. PSUSA/00002046/201806 - periodic safety update report single assessment
  366. EU/3/01/084 - orphan designation for treatment of myelodysplastic syndromes
  367. ema-sevsurySevsury
  368. ema-big-dataBig data
  369. ema-egranliEgranli
  370. Risk classification guide for medical device establishment inspections (GUI-0079)
  371. cdsco-oxaceprol-tablet-600mgOxaceprol tablet 600mg
  372. Gastric Bypass Stent System Approved for Marketing
  373. National assessment procedure for medicines
  374. EMEA-002344-PIP01-18 - paediatric investigation plan
  375. Etrolizumab PhaseII/III
  376. ema-scientific-guidelinesScientific guidelines
  377. 21 CFR 862.1358: Insulin therapy adjustment device.
  378. 21 CFR 11.30: Controls for open systems.
  379. Points to Consider for the Efficacy Evaluation of Drugs for IgA Nephropathy (Early…
  380. Trastuzumab powder for concentrate for solution for intravenous infusion
  381. ema-glyxambiGlyxambi
  382. EU/3/21/2428 - orphan designation for treatment of functional single ventricle congenital…
  383. PSUSA/00010224/201508 - periodic safety update report single assessment
  384. ema-prevora-referralPrevora - referral
  385. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 - 8 June…
  386. PSUSA/00000101/201706 - periodic safety update report single assessment
  387. European Medicines Agency introduces new, faster scientific advice procedure
  388. ema-balaxurBalaxur
  389. EMA adopts first list of critical medicines for COVID-19
  390. Regulators’ advice can make a difference for faster patient access to highly innovative…
  391. EMEA-000149-PIP01-07-M02 - paediatric investigation plan
  392. Committee for Advanced Therapies (CAT): 14-16 June 2017
  393. Reporting adverse incidents involving Software as a Medical Device under the vigilance…
  394. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 18-21…
  395. Ramantamig (JNJ-79635322)
  396. Safety and residues: Biological substances other than immunologicals
  397. ICH E2A Clinical safety data management: definitions and standards for expedited reporting…
  398. ema-tivicayTivicay
  399. NMPA Announcement on the Application of ICH Guideline E9 (R1): Estimands and Sensitivity…
  400. cdsco-inebilizumabinebilizumab
  401. Dapagliflozin + Teneligliptin Hydrobromide Hydrate IP Phase III)
  402. 21 CFR 73.165: Ferrous lactate.
  403. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26…
  404. EU/3/09/621 - orphan designation for treatment of sickle cell disease
  405. European Medicines Agency closed 26 August 2013
  406. 21 CFR 878.3720: Tracheal prosthesis.
  407. PSUSA/00001418/202201 - periodic safety update report single assessment
  408. cdsco-sar236553SAR236553
  409. European Medicines Agency website unavailable Saturday 13 August
  410. EMEA-002016-PIP02-16 - paediatric investigation plan
  411. EMEA-001788-PIP01-15 - paediatric investigation plan
  412. Paediatric medicines: Research and development
  413. Committee for Medicinal Products for Human Use (CHMP): 16-19 September 2024
  414. Duration of protection achieved by veterinary vaccines - Scientific guideline
  415. EMEA-001202-PIP02-13-M04 - paediatric investigation plan
  416. Committee for Orphan Medicinal Products (COMP): 4-6 October 2016
  417. Hamamelidis folium et cortex aut ramunculus destillatum - herbal medicinal product
  418. 21 CFR 73.3112: C.I. Vat Orange 1.
  419. Ergot derivatives - referral
  420. 2022.05.23_Draft GSR 382(E)_Parallel submission in Form 28-D
  421. EU/3/07/449 - orphan designation for treatment of renal-cell carcinoma
  422. Post-market responsibilities (biologicals)
  423. EMEA-002152-PIP02-17-M01 - paediatric investigation plan
  424. 21 CFR 870.4430: Cardiopulmonary bypass intracardiac suction control.
  425. Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 May 2024
  426. Insulin Aspart Injection 100 U/mL
  427. PSUSA/00010815/202107 - periodic safety update report single assessment
  428. CTD Module 1: Administrative information for registered complementary medicines - Guidance…
  429. Will the End of Chevron Impact How We Use Standards?
  430. FDA grants 510(k) Clearance for New Parkinson’s Treatment Mobile App, Parky
  431. Rejection and Debarment of application for submission of fabricated documents by firm M/s…
  432. 21 CFR 801.422: Prescription hearing aid labeling.
  433. EMEA-000205-PIP02-11-M05 - paediatric investigation plan
  434. Revision of “Principle of Residual Replication-Incompetent Genetically Modified Viruses…
  435. PSUSA/00002598/201611 - periodic safety update report single assessment
  436. ema-profenderProfender
  437. PSUSA/00009316/202012 - periodic safety update report single assessment
  438. Anisi aetheroleum - herbal medicinal product
  439. COVID-19 (Adapt Out COVID)
  440. Committee for Medicinal Products for Human Use (CHMP): 16-19 January 2012
  441. EMEA-003051-PIP04-22 - paediatric investigation plan
  442. European Medicines Agency announces plan to publish committee agendas and minutes
  443. European Medicines Agency: Committee for Medicinal Products for Human Use14 - 17 March…
  444. Human medicines Modular Manufacture and Point of Care regulations 2025: Overview
  445. DR_G.S.R. 654(E) dt_24.08.2022_Parallel submission in Form 28-D
  446. NOC Updated list of Medical Devices 2012
  447. 21 CFR 868.6820: Patient position support.
  448. ema-focetriaFocetria
  449. Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2021
  450. Delhi High Court order dated 4.4.2016 for information of all concerned
  451. 21 CFR 868.5650: Esophageal obturator.
  452. Second European Medicines Agency & MedTech Europe bilateral meeting
  453. NMPA Issues the Announcement on Upgrading Related Systems for Drug Registration
  454. European Medicines Agency starts review of ibuprofen medicines
  455. NMPA Announcement on Issuing the Provisions for the Supervision and Administration of…
  456. New “Standard Forms for Requesting Clinical Trials, etc.”
  457. cdsco-pf-06480605PF-06480605
  458. AAMI TIR42 Revamped to Provide Risk-Based Guidance on Controlling Particulate Generation
  459. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June…
  460. EU/3/17/1937 - orphan designation for treatment of pancreatic cancer
  461. Mirabegron (in extended release) Solifenacin Succinate Film coated bilayered tablets…
  462. Implementation of increase in application fees for grant of various import licences…
  463. Quality documentation for medicinal products when used with a medical device - Scientific…
  464. Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation…
  465. Fourth European Medicines Agency - Medicines for Europe bilateral meeting
  466. European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic…
  467. Mitigating risks due to the use of antibiotics in animals
  468. IT systems unavailable from 30 November to 3 December 2018
  469. EudraVigilance information day
  470. EMA starts first rolling review of a COVID-19 vaccine in the EU
  471. Pharmacovigilance Risk Assessment Committee (PRAC): 3-5 September 2012
  472. ema-comfydeComfyde
  473. Guidance for global access of OCTAMS
  474. Angela Ferguson-Bennett: Lighting My HTM Fire
  475. Clarification reg NOC to import of diagnostics kit or reagent for ROU dated 13.07.2012
  476. World Veterinary Day: 28 April 2012
  477. 21 CFR 25.22: Actions requiring the preparation of an environmental impact statement.
  478. EU/3/16/1770 - orphan designation for treatment of adrenoleukodystrophy
  479. Improper Use of Thermal Imaging Devices: FDA Safety Communication
  480. Cyberinsights: Oh, What a Tangled Web We Weave
  481. cdsco-cbt124CBT124
  482. ema-hopguard-goldHopGuard Gold
  483. PSUSA/00001909/202001 - periodic safety update report single assessment
  484. ema-yentreveYentreve
  485. PSUSA/00001621/201510 - periodic safety update report single assessment
  486. Drug Safety Update: monthly PDF newsletter: Drug Safety Update April 2023
  487. EU/3/13/1206 - orphan designation for treatment of spinal cord injury
  488. ema-nityrNityr
  489. European Medicines Agency statement on celecoxib
  490. AAMI's Thomas Kim Named Emerging Professional by SES
  491. Notes on the Principles on Bioequivalence Studies of Oral Solid Dosage Forms with…
  492. In vitro diagnostic point-of-care test devices: Management and use of IVD point of care…
  493. Novartis Vaccines and Diagnostics S.r.l. withdraws its marketing authorisation application…
  494. Committee for veterinary medicinal products: 70th meeting
  495. PSUSA/00001568/202102 - periodic safety update report single assessment
  496. ema-imoxatImoxat
  497. Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal…
  498. Frequently asked questions about parallel distribution
  499. Committee for Advanced Therapies (CAT): 11-12 February 2010
  500. EMEA-001441-PIP03-17-M02 - paediatric investigation plan
  501. Public consultation opens on standard paediatric investigation plans for two types of…
  502. Formulations of choice for the paediatric population - Scientific guideline
  503. Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc)…
  504. EU/3/11/861 - orphan designation for treatment of Leber's congenital amaurosis
  505. EMEA-000533-PIP01-08-M11 - paediatric investigation plan
  506. NSQ ALERT FOR THE MONTH OF MAY-2025
  507. European Medicines Agency holds first scientific workshop on nanomedicines
  508. Fraudulent Drugs
  509. HSCC’s Model Contract Language Template Represents a Win-Win Cybersecurity Solution for…
  510. Gabapentin IP + Nortriptyline HCl IP eq. to Nortriptyline film coated tablets (Phase IV)
  511. Typhoid Conjugate Vaccine (Bivalent)
  512. PSUSA/00010288/201511 - periodic safety update report single assessment
  513. Lint Fiber–Associated Medical Complications Following Invasive Procedures
  514. Import Foods - General
  515. Renewals: Regulatory and procedural guidance
  516. European Medicines Agency's Management Board emphasises the importance of the European…
  517. PSUSA/00001979/201803 - periodic safety update report single assessment
  518. PSUSA/00010339/202107 - periodic safety update report single assessment
  519. Quality: Multidisciplinary
  520. PSUSA/00009251/201510 - periodic safety update report single assessment
  521. ema-raplixaRaplixa
  522. Sue Schade: Eight Signs of a Strong Security Culture
  523. ema-phesgoPhesgo
  524. cdsco-leuprolide-acetateaLeuprolide Acetatea
  525. European Medicines Agency publishes final advice from clinical-trial advisory groups
  526. Committee for Proprietary Medicinal Products (CPMP) 13th plenary meeting
  527. cdsco-desidustatDesidustat
  528. 21 CFR 888.3080: Intervertebral body fusion device.
  529. PSUSA/00002019/201706 - periodic safety update report single assessment
  530. Committee for Herbal Medicinal Products (HMPC): 16-17 September 2013
  531. EU/3/18/2091 - orphan designation for treatment of noninsulinoma pancreatogenous…
  532. PSUSA/00002065/201708 - periodic safety update report single assessment
  533. EU/3/06/352 - orphan designation for treatment of pancreatic cancer
  534. Two new paediatric-use marketing authorisations recommended by CHMP
  535. 21 CFR 890.5740: Powered heating pad.
  536. 21 CFR 882.5900: Preformed craniosynostosis strip.
  537. ema-symkeviSymkevi
  538. 21 CFR 870.4410: Cardiopulmonary bypass in-line blood gas sensor.
  539. Public consultation opens on European Medicines Agency's draft guide on monitoring of…
  540. ema-zurampicZurampic
  541. ema-praxbindPraxbind
  542. Eighth Meeting of the Management Board
  543. PSUSA/00010432/201910 - periodic safety update report single assessment
  544. Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal…
  545. PIC/S Audit Checklist
  546. EMA recommends availability of ellaOne emergency contraceptive without prescription
  547. ema-lyfnuaLyfnua
  548. Paediatric Committee (PDCO): 20-23 June 2017
  549. EU/3/21/2489 - orphan designation for treatment of primary IgA nephropathy
  550. 21 CFR 864.5300: Red cell indices device.
  551. 21 CFR 25.34: Devices and electronic products.
  552. Approval process for Application received in Hard copy with respect to Medical Devices.
  553. ema-lamzedeLamzede
  554. Evaluation for shedding associated with gene therapy products using viruses/vectors
  555. When Life Gives You Sticky Notes... HTM Week 2024
  556. cfr-21-cfr-50-1-scope21 CFR 50.1: Scope.
  557. PSUSA/00010178/202308 - periodic safety update report single assessment
  558. Code-of-Conduct-Team-NB-V5-0-20240916
  559. Considerations for the Clinical Evaluation of Drugs in Pediatric Patients (10 or 12 Years…
  560. 21 CFR 878.5910: Pneumatic tourniquet.
  561. Four Areas HDOs Should Consider When Evaluating the Security of Medical Devices
  562. cdsco-efruxiferminEfruxifermin
  563. ema-parallel-distributionParallel distribution
  564. 21 CFR 874.3880: Tympanostomy tube.
  565. 21 CFR 872.6570: Impression tube.
  566. ema-zyntegloZynteglo
  567. Brexpiprazole Tablets 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg
  568. PSUSA/00000187/202203 - periodic safety update report single assessment
  569. NOC's for manufacture of Unapproved/Banned/New Drugs Solely for Export Purpose
  570. Insulin glargine - paediatric investigation plan
  571. Mirabegron + Solifenacin Succinate tablets (Phase III)
  572. 21 CFR 886.3340: Extraocular orbital implant.
  573. Vildagliptin + Pioglitazone Hydrochloride IP eq. to Pioglitazone film coated tablets…
  574. EU/3/20/2345 - orphan designation for treatment of primary IgA nephropathy
  575. 21 CFR 884.5150: Nonpowered breast pump.
  576. ema-dynastatDynastat
  577. Ninth Industry Standing Group (ISG) meeting
  578. ema-provengeProvenge
  579. EU/3/03/153 - orphan designation for treatment of glioma
  580. FDA Notification about Bioprosthetic Aortic Valve Reduced Leaflet Motion
  581. EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations…
  582. European Medicines Agency website unavailable Saturday 6 September 2014
  583. EMEA-002499-PIP02-19 - paediatric investigation plan
  584. 2026.06.22 G.S.R. 505(E)_Draft notification regarding rationalization of shelf life under…
  585. ema-nimvastidNimvastid
  586. European Medicines Agency recommends restricting use of Multaq
  587. 21 CFR 872.4880: Intraosseous fixation screw or wire.
  588. EMEA-002976-PIP01-21 - paediatric investigation plan
  589. Avanafil tablets 100 mg & 200 mg
  590. European Medicines Agency welcomes new Head of Veterinary Medicines
  591. European Medicines Agency publishes guideline on use of pharmacogenetics in evaluating…
  592. March 6, 2018: Risk Communication Advisory Committee Meeting Announcement - 03/05/2018
  593. MHRA Innovation Office: guidance and support
  594. NBCG-MED 2024-1: Application of hybrid audits to quality management system assessments…
  595. Development, production, characterisation and specifications for monoclonal antibodies and…
  596. 21 CFR 1.1430: What information submitted in a petition requesting a waiver for a type of…
  597. EMEA-000235-PIP02-10-M02 - paediatric investigation plan
  598. Exploring Combination Products' Collaborations and Complications
  599. cdsco-pnb028PNB028
  600. Restrictions in use of cyproterone due to meningioma risk
  601. Concept paper on development of product-specific guidance on demonstration of…
  602. ema-nimesulide-referralNimesulide - referral
  603. Refinements to the Personalised Medical Device Framework
  604. Clinical Trials Information System (CTIS): Walk-in clinic - May 2022
  605. Transforming Healthcare with Lean Six Sigma
  606. ema-onsiorOnsior
  607. Management board meeting: 11 June 2009
  608. AAMI Honors Standards Developers and Committees with 2023 Awards
  609. EMEA/H/N/PSR/J/0031 - periodic safety update report single assessment
  610. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.4) Regulations…
  611. EMEA-000499-PIP03-17 - paediatric investigation plan
  612. PSUSA/00010288/201605 - periodic safety update report single assessment
  613. ema-evalonEvalon
  614. DR_G.S.R. 443(E) dt_30.04.1992_33 (EED))reg prohibition of all Ayuvedic drugs licensed as…
  615. Clinical investigation of medicinal products for the management of Crohn's disease…
  616. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  617. Part IV: Clinical Document
  618. Committee for Orphan Medicinal Products (COMP): 8-9 January 2013
  619. PSUSA/00001503/201504 - periodic safety update report single assessment
  620. 21 CFR 1.621: How must a recognized accreditation body monitor the performance of…
  621. Suzanne Steidl: Hello Challenge! Meet Solution
  622. Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including…
  623. June 26, 2017: Science Board to the Food and Drug Administration Meeting Announcement…
  624. Good laboratory practice (GLP) for safety tests on chemicals
  625. Paediatric Committee (PDCO): 11-13 April 2012
  626. Online presentation: Work-sharing, reliance, and other novel approaches to accelerating…
  627. FDA Drug Safety Communication: Ongoing safety review of Benicar(olmesartan) and…
  628. Meeting highlights from the Paediatric Committee: 10 - 12 December 2008
  629. Twenty-second Meeting of the Management Board
  630. Application for consent to import, supply or export goods that do not comply with…
  631. European Medicines Agency public statement on the suspension of the marketing…
  632. EMEA-002546-PIP01-19 - paediatric investigation plan
  633. Prescription medicines: registration of new chemical entities in Australia, 2014
  634. 21 CFR 26.41: Exchange and endorsement of quality system evaluation reports.
  635. 21 CFR 864.6100: Bleeding time device.
  636. ema-ethanolEthanol
  637. Procedures for Developing Post-marketing Study Plan
  638. 21 CFR 21.31: Records stored by the National Archives and Records Administration.
  639. 21 CFR 882.5150: Intravascular occluding catheter.
  640. EMEA-003272-PIP01-22 - paediatric investigation plan
  641. 21 CFR 74.2334: D&C Red No. 34.
  642. EMEA-003070-PIP01-21 - paediatric investigation plan
  643. Paediatric Committee (PDCO): 17-19 February 2010
  644. 21 CFR 58.33: Study director.
  645. IcoSema and Daily Insulin Glargine 100 units/mL
  646. PSUSA/00002846/201504 - periodic safety update report single assessment
  647. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22…
  648. ema-somnenaSomnena
  649. Ticagrelor 180 mg Tablet
  650. ema-support-servicesSupport services
  651. cfr-21-cfr-888-3000-bone-cap21 CFR 888.3000: Bone cap.
  652. EMEA-003117-PIP02-21 - paediatric investigation plan
  653. AI Plus MRI Promises to be ‘the Right Tool’ for Measuring Alzheimer’s and More
  654. 21 CFR 814.15: Research conducted outside the United States.
  655. Guidance on Advance Notice of Importation under section 21.1 of the Medical Devices…
  656. Committee for Medicinal Products for Human Use (CHMP): 18-21 April 2017
  657. 21 CFR 880.6760: Protective restraint.
  658. 21 CFR 872.3820: Root canal filling resin.
  659. 21 CFR 868.5095: Retrograde intubation device.
  660. Expert meeting on paediatric asthma
  661. Lansoprazol AbZ-Pharma 15 mg and 30 mg - referral
  662. PSUSA/00010288/201911 - periodic safety update report single assessment
  663. Liraglutide Injection, 6 mg/mL
  664. Lymphoseek - direct healthcare professional communication (DHPC)
  665. 21 CFR 868.1400: Carbon dioxide gas analyzer.
  666. HRF-10071tablets 120 mg and Pravastatin 40 mg
  667. Medical devices: Standardised format for the periodic safety update report
  668. Committee for veterinary medicinal products: 65th meeting
  669. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations…
  670. EMA seeks views of public during its safety review of valproate
  671. 21 CFR 862.1495: Magnesium test system.
  672. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 19…
  673. EMEA-001532-PIP01-13 - paediatric investigation plan
  674. European Medicines Agency formalises interaction with healthcare professionals
  675. Condemnation/Disposal of Wooden/Steel junks
  676. cdsco-april-8-2011-s-o-722-eApril 8, 2011 (S.O 722 (E)
  677. cdsco-ifetrobanIfetroban
  678. cdsco-tozorakimabdecTozorakimabdec
  679. Regulatory information - European Medicines Agency updates guidance on European Union…
  680. Procedural advice for vaccine platform technology master file (vPTMF) certification…
  681. EMEA-002746-PIP01-20 - paediatric investigation plan
  682. 21 CFR 21.20: Procedures for notice of Food and Drug Administration Privacy Act Record…
  683. EU/3/19/2195 - orphan designation for treatment of Rett syndrome
  684. 21 CFR 1.284: What are the other consequences of failing to submit adequate prior notice…
  685. EU/3/06/378 - orphan designation for treatment of primary insulin-like growth factor-1…
  686. EU/3/12/981 - orphan designation for treatment of Leber's congenital amaurosis
  687. Isotretinoin for severe acne: uses and effects: Review of isotretinoin and psychiatric…
  688. 21 CFR 884.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  689. ICH E8 General considerations for clinical studies - Scientific guideline
  690. Questions and answers on data requirements when transitioning to low global warming…
  691. EU/3/20/2318 - orphan designation for treatment of amyotrophic lateral sclerosis
  692. The Six Cs of Success: Insights from Joyce Hansen
  693. 21 CFR 864.7290: Factor deficiency test.
  694. Insulin Degludec 100 units/mL
  695. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27…
  696. EU/3/12/973 - orphan designation for treatment of mucopolysaccharidosis type VII (Sly…
  697. Lisa Simone and Daniel Rubery: A Tower of Babel with Medical Device Software Failures
  698. ema-cupryminaCuprymina
  699. EU/3/16/1689 - orphan designation for treatment of hypoparathyroidism
  700. NMPA Issued Three Guidelines for Technical Review of the Registration of Embryo…
  701. Committee for Advanced Therapies (CAT): 18-20 July 2018
  702. Favipiravir tablet 200 mgw
  703. EU/3/10/768 - orphan designation for treatment of primary myelofibrosis
  704. ema-aggrastat-referralAggrastat - referral
  705. FDA Announces Two Innovation Challenges for Ethylene Oxide Sterilization Alternatives
  706. EU/3/09/711 - orphan designation for treatment of amyotrophic lateral sclerosis
  707. PSUSA/00001539/201703 - periodic safety update report single assessment
  708. 2025.05.16_S.O. 2208 and S.O. 2209_Notification of Director Incharge, CDL Kolkata
  709. ema-evotazEvotaz
  710. Using the Influencer Change Model for Alarm Management
  711. Non availability of life saving drug(D-Penicillamine) across India-Regarding
  712. EU/3/16/1735 - orphan designation for treatment of glioma
  713. ema-melovemMelovem
  714. PSUSA/00001731/201511 - periodic safety update report single assessment
  715. FDA warns about serious breathing problems with seizure and nerve pain medicines…
  716. EMEA-001501-PIP03-15 - paediatric investigation plan
  717. PSUSA/00000265/201411 - periodic safety update report single assessment
  718. ICH E12 Principles for clinical evaluation of new antihypertensive drugs - Scientific…
  719. PSUSA/00010853/202211 - periodic safety update report single assessment
  720. Medicines for human use under evaluation
  721. Active Substance Master File Working Group
  722. Guidelines-Risk-Classification-SAMD-CDSS (2022 Apr) PUB
  723. NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med…
  724. Thalidomide - Follow-up meeting with patients' and victims' organisations
  725. Committee for Medicinal Products for Human Use (CHMP): 22-25 April 2014
  726. 21 CFR 870.2640: Portable leakage current alarm.
  727. cdsco-osilodrostat-lci699osilodrostat (LCI699)
  728. Committee for Medicinal Products for Human Use (CHMP): 25-28 February 2019
  729. EU/3/14/1427 - orphan designation for treatment of hypophosphatasia
  730. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13…
  731. 7th October 2005 (GSR 627 (E)
  732. cdsco-durvalumab1Durvalumab1
  733. Refusal of orphan designation for treatment of eumycetoma
  734. European Medicines Agency/European Federation of Pharmaceutical Industries and…
  735. Refusal of orphan designation for treatment of fibromyalgia
  736. European Medicines Agency publishes first public summaries of Paediatric Committee…
  737. Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
  738. Publication of the New Editions of the Standards for Medical Device Interoperability…
  739. cfr-21-cfr-54-1-purpose21 CFR 54.1: Purpose.
  740. EMEA-001299-PIP01-12 - paediatric investigation plan
  741. cdsco-ceftazidimeCeftazidime
  742. Variations including extensions of marketing authorisations
  743. P/111/2010 - paediatric investigation plan
  744. 21 CFR 882.5550: Central nervous system fluid shunt and components.
  745. Abbe Meehan: How to Improve Your Customer Service Skills
  746. EMEA-003205-PIP01-22 - paediatric investigation plan
  747. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-8 July…
  748. EMEA-000406-PIP01-08-M04 - paediatric investigation plan
  749. EMEA completes the review of recombinant factor VIII products and inhibitor development
  750. Pfizer Limited withdraws its application for an extension of the indication for Macugen…
  751. ema-cardioxane-referralCardioxane - referral
  752. Making a difference to human and animal health
  753. PSUSA/00010336/202207 - periodic safety update report single assessment
  754. 21 CFR 56.105: Waiver of IRB requirement.
  755. Drug Alert list for month of August 2013
  756. Posaconazole product-specific bioequivalence guidance
  757. Workshop on adaptive pathways – discussion on development approach for medicines…
  758. EU/3/02/105 - orphan designation for treatment of cystic fibrosis
  759. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 April…
  760. IVD Diagnostic Kit Alert for Mediclone D
  761. EMEA-001489-PIP02-19 - paediatric investigation plan
  762. 21 CFR 878.5040: Suction lipoplasty system.
  763. EMEA-003096-PIP02-22 - paediatric investigation plan
  764. ICH E10 Choice of control group in clinical trials - Scientific guideline
  765. EMEA-000791-PIP01-09 - paediatric investigation plan
  766. EU/3/07/518 - orphan designation for treatment of pulmonary arterial hypertension
  767. 21 CFR 878.4010: Tissue adhesive.
  768. Human cell line recombinant Factor VIII
  769. 21 CFR 1.507: What requirements apply when I import a food that cannot be consumed without…
  770. Guidance on using evaluation reports from Comparable Overseas Bodies
  771. Ghryvelin (previously Macimorelin Aeterna Zentaris)
  772. EU/3/20/2262 - orphan designation for treatment of biliary tract cancer
  773. 2009 annual workshop of the European Network of Paediatric Research at the European…
  774. Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118)
  775. EU/3/12/984 - orphan designation for treatment of chronic lymphocytic leukaemia
  776. PRAC recommends restricting the use of codeine when used for pain relief in children
  777. Management Board initiates building approval process for EMA premises in Amsterdam
  778. cfr-21-cfr-73-1085-caramel21 CFR 73.1085: Caramel.
  779. First treatment recommended for rare bone disease
  780. 21 CFR 886.4855: Ophthalmic instrument table.
  781. QMS F0008.3: Internal Assessment Qualification / Training Form
  782. Clinical Trials Information System (CTIS) bitesize talk: Initial clinical trial…
  783. EMEA-001220-PIP01-11-M08 - paediatric investigation plan
  784. ema-novosevenNovoSeven
  785. 21 CFR 866.3169: Hepatitis C virus antibody tests.
  786. Regulatory information – revised guideline on acceptability of names for human medicines…
  787. cdsco-oral-aur105Oral AUR105
  788. Diclofenac Sodium Spray Gel 4% - referral
  789. ema-octagam-referralOctagam - referral
  790. EMEA-000284-PIP01-08-M04 - paediatric investigation plan
  791. Public statement on possible interaction between clopidogrel and proton pump inhibitors
  792. Team-NB-List-PositionPapers-20241125
  793. 21 CFR 801.430: User labeling for menstrual tampons.
  794. EMEA-000380-PIP04-10 - paediatric investigation plan
  795. EU/3/22/2678 - orphan designation for prevention of acute liver failure
  796. Bacterial lysates-containing medicinal products indicated for respiratory conditions…
  797. 21 CFR 886.5916: Rigid gas permeable contact lens.
  798. PSUSA/00010283/201507 - periodic safety update report single assessment
  799. EU/3/03/185 - orphan designation for treatment of vernal keratoconjunctivitis
  800. 21 CFR 812.46: Monitoring investigations.
  801. ema-prialtPrialt
  802. Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical…
  803. AAMI News, May 2022, Vol.57, No.5
  804. 21 CFR 880.5110: Hydraulic adjustable hospital bed.
  805. Committee for Herbal Medicinal Products (HMPC): 14-15 January 2013
  806. EudraVigilance training on electronic reporting of ICSRs in the EEA
  807. Committee for Herbal Medicinal Products (HMPC): 26-27 March 2012
  808. EU/3/21/2481 - orphan designation for treatment of diffuse large B-cell lymphoma
  809. EU/3/12/1082 - orphan designation for treatment of long-chain 3-hydroxyacyl-coenzyme A…
  810. FDA Issues Final Guidance for Animal Studies to Evaluate Medical Devices
  811. Acceleration of Innovation Prompts Revival of Prestigious Sterility Assurance Conference
  812. Eleventh industry stakeholder platform on the operation of pharmacovigilance in the…
  813. EudraVigilance: security principles and responsibilities
  814. 21 CFR 74.1101: FD&C Blue No. 1
  815. Meningococcal Group A, C, W-135, Y, X Conjugate Vaccine (Adsorbed & Unadsorbed)
  816. Update on rolling review of AstraZeneca’s COVID-19 vaccine
  817. PSUSA/00000112/202205 - periodic safety update report single assessment
  818. Guidance on regulatory requirements in the context of the COVID-19 pandemic
  819. Menopausal Gonadotropin
  820. EMA business hours over Easter holiday
  821. Apremilast Topcial Gel 2%
  822. Regulations Governing Accreditation and Outsourced Accreditation Management of Drugs…
  823. 21 CFR 74.2321: D&C Red No. 21.
  824. EMA Management Board discusses next steps after judgment of EU Civil Service Tribunal
  825. Calcipotriol/AKVANO 50 µg/g cutaneous solution
  826. World Alzheimer's Month - Supporting development of medicines by qualification of…
  827. Memantine product-specific bioequivalence guidance
  828. Reporting side effects of medicines
  829. Machine learning medical devices: transparency principles
  830. EU/3/06/405 - orphan designation for treatment of renal-cell carcinoma
  831. Proposed 'Approved Herbal Name' (AHN) or 'Approved Herbal Substance' (AHS) name…
  832. EMEA-001769-PIP01-15 - paediatric investigation plan
  833. 21 CFR 870.2060: Transducer signal amplifier and conditioner.
  834. PIC/S Annex 11: Computerised Systems
  835. European Medicines Agency confirms positive benefit-risk balance of MabThera
  836. European Medicines Agency creates Healthcare Professionals' Working Party
  837. EU/3/15/1474 - orphan designation for treatment of Stargardt's disease
  838. Novartis withdraws its application to extend the marketing authorisation for Glivec
  839. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29…
  840. Leuprorelin depot medicines: PRAC recommends new measures to avoid handling errors
  841. EMEA-002846-PIP01-20 - paediatric investigation plan
  842. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  843. Rituximab 10mg/mL (500mg/50mL) (rDNA origin) , supplied as a single use vial
  844. NMPA Announcement on the Good Manufacturing Practice for Cosmetics
  845. ema-wyostWyost
  846. Nortriptyline IP + Methylcobalamin IP + Pregabalin IP (SR) Film Coated Tablets (Phase III)
  847. EU/3/08/591 - orphan designation for treatment of Duchenne muscular dystrophy
  848. PSUSA/00002149/201605 - periodic safety update report single assessment
  849. Illegal Drug Residues in Meat, Poultry, Seafood and Other Animal Derived Foods
  850. Revision of Technical Conformance Guide
  851. 21 CFR 864.7360: Erythrocytic glucose-6-phosphate dehydrogenase assay.
  852. EMEA celebrates 10th anniversary
  853. QMS P0013.004: Continual Improvement Procedure
  854. Sitagliptin Phosphate IP 100mg + Lobeglitazone Sulfate 0.5mg film coated tablet
  855. Human medicines: highlights of 2022
  856. EU/3/08/567 - orphan designation for treatment of cutaneous T-cell lymphoma
  857. ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric…
  858. Update of EU recommendations for 2019–2020 seasonal flu vaccine composition
  859. COVID-19: Beware of falsified medicines from unregistered websites
  860. DR_G.S.R. 390(E) dt_18.05.2015_Amendment Rule 157_No prefix & suffix for Aurvedic siddha…
  861. EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
  862. EU/3/02/101 - orphan designation for treatment of glioma
  863. Product Shortage of Advanced Sterilization Products Sterrad Cyclesure 24 Biological…
  864. EU/3/23/2867 - orphan designation for treatment of Leigh syndrome
  865. CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated…
  866. EMA working on COVID-19 and Brexit over holiday period
  867. EMEA-002825-PIP01-20 - paediatric investigation plan
  868. 21 CFR 864.2360: Mycoplasma detection media and components.
  869. European Medicines Agency recommends restricting use of Pandemrix
  870. First anniversary of PRIME – experience so far
  871. Drug Alert list for September 2018
  872. Team-NB-PositionPaper-TransferAgreement-v02-20240702-with-instructions
  873. 21 CFR 822.1: What does this part cover?
  874. Estradiol Valerate 4mg SR Table
  875. EMEA-000838-PIP01-10-M02 - paediatric investigation plan
  876. Workshop on the use of pharmacokinetics and pharmacodynamics in the development of…
  877. Consultation on Good Manufacturing Practices- Program Review
  878. ema-jenzylJenzyl
  879. EMEA-003255-PIP01-22 - paediatric investigation plan
  880. Diclofenac epolamine 50 mg tablets - referral
  881. Team-NB-List-PositionPapers-20240613
  882. ema-taxotereTaxotere
  883. PSUSA/00002125/201708 - periodic safety update report single assessment
  884. European Medicines Agency alerts EU healthcare professionals after vials of falsified…
  885. EudraVigilance and signal management information day
  886. EU/3/07/494 - orphan designation for treatment of chronic lymphocytic leukaemia
  887. EU/3/21/2418 - orphan designation for treatment of gastrointestinal stromal tumours
  888. Toronto 2015 Pan American and Parapan American Games - Importing and Exporting Controlled…
  889. Focus on Human Factors: Classifying Medical Device Human Factors Issues for the MAUDE and…
  890. EMEA-000951-PIP01-10 - paediatric investigation plan
  891. Office Memorandum: Form 29 license to manufacture drugs for examination, test or analysis…
  892. EMEA-002940-PIP02-21 - paediatric investigation plan
  893. Release of documents on two medicines temporarily halted
  894. EU/3/13/1141 - orphan designation for treatment of pachyonychia congenita
  895. PSUSA/00001351/202309 - periodic safety update report single assessment
  896. Data requirements for intravenous liposomal products developed with reference to an…
  897. Provisions for In-vitro Diagnostic Reagent Registration (Abolished)
  898. DARWIN EU Advisory Board meeting: 6 July 2022
  899. Committee for Proprietary Medicinal Products (CPMP) 27th plenary meeting
  900. EU/3/09/675 - orphan designation for treatment of haemophilia A
  901. cdsco-amt-101AMT-101
  902. Questions and answers on requirements for pre-clinical studies submitted in support of a…
  903. EMEA-002657-PIP01-19 - paediatric investigation plan
  904. 21 CFR 870.2100: Cardiovascular blood flowmeter.
  905. ema-puregonPuregon
  906. European Medicines Agency recommends suspension of classical swine fever vaccine Porcilis…
  907. EU/3/24/2900 - orphan designation for treatment of AL amyloidosis
  908. Ledipasvir/sofosbuvir product-specific bioequivalence guidance
  909. Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)…
  910. DRL Vedolizumab 300mg vial
  911. PSUSA/00010665/202105 - periodic safety update report single assessment
  912. GN-24-R1.4 Guidance on the Change of Registrant (22 Mar-pub)
  913. EU/3/11/881 - orphan designation for treatment of multiple myeloma
  914. 21 CFR 886.5700: Eyelid weight.
  915. Bedaquiline, Delamanid, Linezolid and Clofazimine
  916. Workshop on clinical-trial data and transparency this afternoon
  917. ema-tuznueTuznue
  918. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  919. Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)
  920. Assessment and procurement of coronavirus (COVID-19) tests: Outcome of the evaluation of…
  921. European Medicines Agency (EMA) Human Scientific Committees' Working Parties with…
  922. Committee for Advanced Therapies (CAT): 17-19 July 2013
  923. 21 CFR 74.203: FD&C Green No. 3.
  924. AAMI Health IT Committee Embraces Life Cycle Approach in Developing HIT1000 Series of…
  925. Development of a guideline on quality requirements of medicinal products containing a…
  926. European Medicines Agency recommends update of product information of Tysabri and risk of…
  927. Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA…
  928. Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022
  929. cdsco-tozorakimabTozorakimab
  930. EMEA-003260-PIP01-22 - paediatric investigation plan
  931. EudraVigilance training on electronic reporting of individual case safety reports in the…
  932. Data on medicines (ISO IDMP standards): Overview
  933. PSUSA/00000167/202301 - periodic safety update report single assessment
  934. 21 CFR 884.4900: Obstetric table and accessories.
  935. EMEA-002695-PIP01-19 - paediatric investigation plan
  936. EMEA-001615-PIP01-13 - paediatric investigation plan
  937. PSUSA/00002024/202110 - periodic safety update report single assessment
  938. cdsco-pnb-001PNB-001
  939. Drug Alert list for month of February 2019
  940. COVID-19 guidance: research and development
  941. ema-pelmegPelmeg
  942. cdsco-bion-1301BION-1301
  943. 21 CFR 1.1400: What procedures apply if FDA tentatively determines that modified…
  944. ema-pravafenixPravafenix
  945. Isolators Used for Aseptic Processing and Sterility Testing
  946. nbcg-team-nb-bullet-pointsTEAM-NB-Bullet-Points
  947. NMPA Announcement on Issuing the Provisions for Administration of Self-Test for Medical…
  948. EU/3/19/2154 - orphan designation for treatment of fragile X syndrome
  949. EU/3/01/043 - orphan designation for treatment of ovarian cancer
  950. 21 CFR 866.3405: Poliovirus serological reagents.
  951. 2021.02.05_Draft GSR 98(E)_American Standard Test Method (ASTM) in the product standards…
  952. EU/3/09/685 - orphan designation for treatment of pancreatic cancer
  953. Implementation of Advance Notice of Importation Process for Medical Devices
  954. ema-yuvanciYuvanci
  955. ICH E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic…
  956. EU/3/13/1185 - orphan designation for treatment of neuromyelitis optica spectrum disorders
  957. Get to Know the AAMI Standards Team: Sam Alameda, Program Manager
  958. Clinical investigation of medicinal products for prevention of venous thromboembolism…
  959. cfr-21-cfr-17-1-scope21 CFR 17.1: Scope.
  960. Alogliptin Benzoate eq. to Alogliptin + Metformin Hydrochloride IP Film Coated Tablet…
  961. Cosmetic Product Manufacturers
  962. Introduction to pharmacovigilance and rules for expedited reporting of individual case…
  963. 21 CFR 880.6960: Irrigating syringe.
  964. EU/3/13/1166 - orphan designation for treatment of citrullinaemia type 2
  965. Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO…
  966. PSUSA/00002996/201701 - periodic safety update report single assessment
  967. Notice - Release of information about Medical Device Investigational Testing Applications…
  968. PF-08046047 – SGN B6A –Sigvotatug Vedotin
  969. Format for Preparing the Common Technical Document for Submission of New Drug Applications…
  970. Utilizing Artificial Intelligence to Aid SPDs in Cleaning Verification
  971. FDA Makes Progress on Safety and Performance Pathway
  972. 21 CFR 878.4460: Non-powdered surgeon's glove.
  973. PSUSA/00002897/202112 - periodic safety update report single assessment
  974. Union Pharmacovigilance Database: follow up webinar on signal detection, evaluation and…
  975. Committee for Advanced Therapies (CAT): 15-17 April 2026
  976. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 April 2026
  977. 17β-Hydroxysteroid Dehydrogenase type 13
  978. Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products…
  979. EU/3/09/669 - orphan designation for prevention of graft rejection during pancreatic islet…
  980. cdsco-grouping-faq-updatedGrouping FAQ Updated
  981. EMEA-000486-PIP01-08-M04 - paediatric investigation plan
  982. EMEA-000491-PIP01-08-M01 - paediatric investigation plan
  983. Bivalent Typhoid and Paratyphoid A Conjugate Vaccine
  984. Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events
  985. EMEA-001128-PIP01-10 - paediatric investigation plan
  986. eXtended EudraVigilance Medicinal Product Dictionary training course - September 2021
  987. Updating organisation administrator
  988. EMEA-002403-PIP01-18 - paediatric investigation plan
  989. Chapter 1 - Submitting Notifications EUCEG Guidance - Northern Ireland: Chapter 1…
  990. EMEA announces appointment of new Head of Unit for Human Medicines
  991. Phasing out of extraordinary COVID-19 regulatory flexibilities
  992. cdsco-akp02g2AKP02G2
  993. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 March 2014
  994. Ministerial Ordinance on Good Clinical Practice for Drugs (as amended, effective May 20…
  995. PSUSA/00010137/202009 - periodic safety update report single assessment
  996. 21 CFR 1.503: Who must develop my FSVP and perform FSVP activities?
  997. Vonoprazan Fumarate 20mg tablet
  998. EU/3/15/1603 - orphan designation for treatment of pancreatic cancer
  999. ANSI/AAMI CN27:2021: Serving a Vital Role in Aligning Requirements for Luer-Activated…

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