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Global regulations and guidance

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

  1. Armisarte (previously Pemetrexed Actavis)
  2. ICMR-CDSCO Standard Performance Evaluation Protocols
  3. EU/3/19/2237 - orphan designation for treatment of Huntington's disease
  4. EMA press briefing to update on analysis of data on Vaxzevria, the COVID-19 vaccine from…
  5. 21 CFR 892.1950: Radiographic anthropomorphic phantom.
  6. MDS - REQ 2: Requirements for Clinical Trials of Medical Devices
  7. EU/3/23/2808 - orphan designation for treatment of Alport syndrome
  8. PSUSA/00000491/202206 - periodic safety update report single assessment
  9. Shades of Gray: New AAMI Report Offers Guidance for Medical Equipment Service…
  10. 21 CFR 74.2053: D&C Black No. 3.
  11. MDAC Miscellaneous Devices
  12. Guidance on Secondary Packaging of Therapeutic and Medicinal Products (GUIDE-MQA-031)
  13. Pharmacovigilance Risk Assessment Committee (PRAC): 28-31 August 2023
  14. EMEA-000928-PIP01-10-M01 - paediatric investigation plan
  15. ema-repaglinide-tevaRepaglinide Teva
  16. EMEA-003337-PIP01-22 - paediatric investigation plan
  17. AAMI News, April 2020, Vol. 55, Issue 4
  18. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15…
  19. cfr-21-cfr-814-3-definitions21 CFR 814.3: Definitions.
  20. Access New Active Substance and Biosimilar Work Sharing Initiatives
  21. EMEA-002802-PIP02-21 - paediatric investigation plan
  22. VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90)…
  23. 2021.06.28_SO 2609(E)_Notification of NCCS Pune for COVID Vaccine testing valid till one…
  24. cdsco-volrustomigVolrustomig
  25. Committee for Orphan Medicinal Products (COMP): 10-12May 2017
  26. EU/3/10/796 - orphan designation for treatment of Behçet's Disease
  27. cdsco-biapenam-injectionBiapenam injection
  28. EMEA-000758-PIP01-09 - paediatric investigation plan
  29. Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A…
  30. 2018.08.10_Draft GSR 763(E)_Inclusion of Oxytocin under Schedule H1
  31. Canada Vigilance Program - Collecting and Assessing Adverse Reaction Reports
  32. ema-imrestorImrestor
  33. New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs…
  34. Jcovden (previously COVID-19 Vaccine Janssen)
  35. EU/3/22/2676 - orphan designation for treatment of idiopathic hypersomnia
  36. New recommendations on the use of phthalates and parabens as excipients in human medicines…
  37. Good Manufacturing Practices - Request for an Inspection of a Foreign Site Form (FRM-0213)
  38. ema-glustinGlustin
  39. Regulatory science research needs
  40. EMEA-003076-PIP01-21 - paediatric investigation plan
  41. Office Memorandum dated 29.09.2014 reg. Relabeling or stickering on the label of cosmetics
  42. EU/3/06/422 - orphan designation for treatment of ovarian cancer
  43. Medical literature monitoring workshop
  44. 16th meeting of the committee for veterinary medicinal products
  45. EU/3/20/2272 - orphan designation for treatment of myasthenia gravis
  46. cdsco-jnj-77242113JNJ-77242113
  47. Guidance on Free Sale Certificate of Notified MD in India
  48. ema-zynteglo-referralZynteglo - referral
  49. PSUSA/00010288/201711 - periodic safety update report single assessment
  50. ema-simulectSimulect
  51. Submitting changes to labelling and patient information leaflets: Application for changes…
  52. EU/3/11/920 - orphan designation for diagnosis of gastro-entero-pancreatic neuroendocrine…
  53. ema-clopidogrel-acinoClopidogrel Acino
  54. ema-wakixWakix
  55. 21 CFR 862.1075: Androstenedione test system.
  56. cdsco-nov-14-2009-s-o-3077Nov_14,2009(S.O.3077)
  57. NMPA Issued the Technical Guidelines for Endpoints in Clinical Trials for Advanced…
  58. AU P0008.007: Audit Time Determination Procedure
  59. EU/3/20/2353 - orphan designation for treatment of gastric cancer
  60. Single-use medical devices
  61. PSUSA/00003015/201703 - periodic safety update report single assessment
  62. 15-Valent Pneumococcal Conjugate Vaccine (PCV15)
  63. EMEA-001860-PIP04-16 - paediatric investigation plan
  64. Drug Alert list for month of October 2020
  65. Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib)…
  66. ema-lytgobiLytgobi
  67. Torsemide Extended Release
  68. European Medicines Agency: Committee for Medicinal Products for Human Use14-17 February…
  69. EMEA-000184-PIP03-16 - paediatric investigation plan
  70. Active Pharmaceutical Ingredients (PDF - 150 KB)
  71. 21 CFR 884.2730: Home uterine activity monitor.
  72. Fighting antimicrobial resistance globally
  73. 21 CFR 1.1460: What consequences could result from failing to comply with the requirements…
  74. EMEA-000737-PIP01-09 - paediatric investigation plan
  75. 21 CFR 1.665: What if I want to voluntarily relinquish accreditation or do not want to…
  76. ema-xapitXapit
  77. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19–21 June 2018
  78. Innovative Licensing and Access Pathway (ILAP)
  79. EU/3/20/2347 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  80. 21 CFR 870.3600: External pacemaker pulse generator.
  81. Clinical trials for medicines: good manufacturing practice and radiopharmaceutical…
  82. ema-fluenzFluenz
  83. EudraVigilance training on electronic reporting of individual case safety reports in the…
  84. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 February 2014
  85. Paediatric Committee (PDCO): 9-11 December 2019
  86. Chapter 3 - Emissions Guidance Northern Ireland
  87. 21 CFR 888.3490: Knee joint femorotibial metal/composite non-constrained cemented…
  88. FDA warns about prescribing and dispensing errors resulting from brand name confusion with…
  89. EMEA-001729-PIP02-18 - paediatric investigation plan
  90. McLaren Health Leader Recognized With 2022 AAMI Award
  91. Committee for veterinary medicinal products: 79th meeting
  92. Submission of Innovation Office Requests
  93. Cancellation of products under RC/COS-005358, for import of Cosmetics under Cosmetics…
  94. Better protection of public health: European Medicines Agency counts down to introduction…
  95. Tailored scientific advice to support step-by-step development of new biosimilars
  96. EU/3/05/344 - orphan designation for treatment of medullary thyroid carcinoma
  97. 21 CFR 866.2680: Streptococcus spp. nucleic acid-based assay.
  98. PSUSA/00001535/201901 - periodic safety update report single assessment
  99. 21 CFR 872.4730: Dental injecting needle.
  100. PSUSA/00001902/201801 - periodic safety update report single assessment
  101. EU/3/22/2746 - orphan designation for treatment of dopamine transporter deficiency…
  102. Diphtheria and Tetanus Vaccine (Adsorbed) for Adults & Adolescents I.P
  103. EMA recommends restricting use of cancer medicine Rubraca
  104. Committee for Orphan Medicinal Products (COMP): 12-14 July 2022
  105. ema-micardisplusMicardisPlus
  106. Validation of Cleaning Processes (7/93)
  107. PSUSA/00000795/201510 - periodic safety update report single assessment
  108. EMEA-002247-PIP03-17-M01 - paediatric investigation plan
  109. ema-comfortisComfortis
  110. FDA Authorizes Over 100 New AI/ML Enabled Devices in Recent Months
  111. cdsco-pegozaferminPegozafermin
  112. Chapter 7 - Annual Reporting Guidance Northern Ireland: Chapter 7 - Annual Reporting…
  113. Committee for Medicinal Products for Human Use (CHMP): 27-29 May 2019
  114. EMEA-000205-PIP01-08-M02 - paediatric investigation plan
  115. Points to Consider When Applying for Marketing Approval for Medical Devices
  116. NMPA Announcement on Issuing the Rules for Registration and Notification Dossiers of New…
  117. Report of the manufacture of exempt therapeutic goods
  118. M-RNA Vaccine for Injection (Covid-19)
  119. Workshop on the development of an EMEA transparency policy
  120. Your SPD Needs Dedicated Endoscope Staff, Urges ST91 Co-chair
  121. EMEA-001742-PIP02-16 - paediatric investigation plan
  122. ema-task-forcesTask Forces
  123. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - May 2022
  124. EU/3/13/1184 - orphan designation for treatment of sickle cell disease
  125. EU/3/12/1012 - orphan designation for treatment of Cushing's syndrome
  126. ema-ferahemeFeraheme
  127. Drug Listing - Labeling Review
  128. EMEA-001741-PIP04-17-M02 - paediatric investigation plan
  129. ema-refacto-afReFacto AF
  130. Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing…
  131. Acceptance Criteria for test and examination of Blood Glucose Test Strips & Analyzer base…
  132. 21 CFR 866.2300: Multipurpose culture medium.
  133. 21 CFR 884.5360: Contraceptive intrauterine device (IUD) and introducer.
  134. ema-esperoctEsperoct
  135. 3D Printing Helps VA Patient Who Was ‘Grasping at Straws’
  136. Antipsychotic medicines: licensed products, uses and side effects: Antipsychotic medicines
  137. Imeglimin Hydrochloride sustend release tablets 1000 mg
  138. EMEA/H/N/PSR/S/0029 - periodic safety update report single assessment
  139. EU/3/05/346 - orphan designation for treatment of autoimmune uveitis
  140. EMEA-000694-PIP02-14-M03 - paediatric investigation plan
  141. EMEA-000057-PIP01-07-M07 - paediatric investigation plan
  142. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 October 2012
  143. EMEA-002545-PIP01-19-M01 - paediatric investigation plan
  144. Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2016
  145. Form F202 for filing a new Quality Management System Certificate or a modification to an…
  146. Second information day on the new individual case safety report (ICSR) international…
  147. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July…
  148. Rilpivirine product-specific bioequivalence guidance
  149. PSUSA/00000902/202012 - periodic safety update report single assessment
  150. Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on…
  151. Policy on Drug/Medical Device Combination Products - Decisions
  152. UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety…
  153. First monoclonal antibody therapy for prevention of migraine
  154. Coordination of GCP inspections
  155. EMEA-002061-PIP01-16 - paediatric investigation plan
  156. 21 CFR 884.1050: Endocervical aspirator.
  157. ema-poulvac-flufend-h5n3-rgPoulvac Flufend H5N3 RG
  158. ema-alofiselAlofisel
  159. cdsco-divozilimabDivozilimab
  160. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  161. cdsco-pf-07321332-ritonavirPF-07321332/Ritonavir
  162. Vaxzevria (previously COVID-19 Vaccine AstraZeneca) - direct healthcare professional…
  163. Vflower® Venous Stent System Approved for Marketing
  164. 21 CFR 70.10: Color additives in standardized foods and new drugs.
  165. ema-bimervaxBimervax
  166. PSUSA/00002695/201601 - periodic safety update report single assessment
  167. GN-18 R1.1 Guidance on Preparation of a Product Registration Submission for In-Vitro…
  168. ema-signal-managementSignal management
  169. ema-cereproCerepro
  170. cdsco-sept-29-2011-gsr-733-eSept 29, 2011 (GSR 733(E))
  171. PSUSA/00010226/201905 - periodic safety update report single assessment
  172. cdsco-ly3537031LY3537031
  173. EMEA-003317-PIP02-22 - paediatric investigation plan
  174. Drug Alert list for month of July 2014
  175. 21 CFR 862.1635: Total protein test system.
  176. Classification of Medical Device pertaining to General Hospital under the provisions of…
  177. UPDATED AGENDA AND PUBLIC PARTICIPATION INFORMATION: November 9, 2022 Meeting of the…
  178. Committee for Medicinal Products for Human Use (CHMP): 17-20 August 2026
  179. EMEA-003334-PIP01-22 - paediatric investigation plan
  180. Notice regarding Streamline the grievance
  181. Guidance on GMP Inspection Reliance
  182. Aflibercept Solution for Injection 40mg/ml in Vial (r-DNA origin)
  183. EMEA-002257-PIP02-19 - paediatric investigation plan
  184. Tadalafil IP 5mg (as film coated tablet) + Tamsulosin Hydrochloride IP 0.4mg (Prolonged…
  185. ema-relistorRelistor
  186. Post-authorisation: Background information
  187. EMEA/H/N/PSR/J/0005 - periodic safety update report single assessment
  188. EMEA-002979-PIP03-21 - paediatric investigation plan
  189. EMA-HTA workshop on parallel scientific advice in drug development takes place today
  190. 2026.06.29 G.S.R. 530(E)_Notification regarding Inclusion of additional items under CLAA…
  191. EMEA-001434-PIP01-13-M03 - paediatric investigation plan
  192. Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry)
  193. Regulatory guidelines on taking action on NSQ drugs
  194. 21 CFR 26.17: Role and composition of the Joint Sectoral Committee.
  195. 21 CFR 868.5240: Anesthesia breathing circuit.
  196. Regulatory information - EMA issues recommendations for 2014/2015 seasonal flu vaccine…
  197. Third listen-and-learn focus group meeting of the Quality Innovation Group
  198. Dec_11,2009(G.S.R_884(E)
  199. Medicine shortages and availability issues: guidance for regulators
  200. 21 CFR 25.16: Public health and safety emergencies.
  201. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 April 2016
  202. 21 CFR 872.3250: Calcium hydroxide cavity liner.
  203. Evaluation of Production Cleaning Processes for Electronic Medical Devices - Part II…
  204. EMEA-002430-PIP01-18 - paediatric investigation plan
  205. European Medicines Agency statement on the safety of Gardasil
  206. FDA Makes the Case for Quality
  207. Doxorubicin Hydrochloride Tillomed
  208. DR_G.S.R. 733(E) dt_21.12.2005_Amendment Rule 122F, 122G, Schedule F
  209. EMEA-003370-PIP01-22 - paediatric investigation plan
  210. Committee for Orphan Medicinal Products (COMP): 1-2 June 2010
  211. How HTM Humanitarian Shauna Mullally Improves Lives Around the World
  212. EU/3/01/051 - orphan designation for treatment of systemic secondary amyloidosis
  213. COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
  214. Specification for Rapidly Manufactured CPAP System to be used during the coronavirus…
  215. Water Activity (a{{w}}) in Foods
  216. New VA Center Aims to Partner with Industry on Risk Assessment
  217. mhra-access-consortiumAccess Consortium
  218. ema-velosulinVelosulin
  219. PSUSA/00001104/201909 - periodic safety update report single assessment
  220. PSUSA/00000775/202304 - periodic safety update report single assessment
  221. Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 December 2010
  222. Register of brokers authorised to deal in human medicines
  223. 21 CFR 880.5130: Infant radiant warmer.
  224. EU/3/20/2302 - orphan designation for treatment of carnitine-acylcarnitine translocase…
  225. EMA working on COVID-19 over holiday period
  226. 21 CFR 14.80: Qualifications for members of standing policy and technical advisory…
  227. EMEA-000310-PIP03-10-M06 - paediatric investigation plan
  228. Top 10 for 2022: AAMI Standards Year in Review
  229. Irbesartan/Hydrochlorothiazide Teva
  230. ema-akynzeoAkynzeo
  231. Annual report 2009 published: "Agency achieved very good results in one of the most…
  232. EU/3/20/2257 - orphan designation for treatment of peripheral T-cell lymphoma
  233. EU/3/13/1232 - orphan designation for treatment of epidermolysis bullosa
  234. ema-upcardUpCard
  235. 21 CFR 886.4250: Ophthalmic electrolysis unit.
  236. EU/3/05/330 - orphan designation for treatment of cardiogenic shock
  237. European Medicines Agency improves package leaflets
  238. Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
  239. ema-ratiograstimRatiograstim
  240. ema-search-tipsSearch tips
  241. European Medicines Agency (EMA) Human Scientific Committees' Working Parties with…
  242. EU/3/16/1649 - orphan designation for treatment of progressive supranuclear palsy
  243. Herbal medicinal products containing cimicifugae racemosae rhizoma - serious hepatic…
  244. PSUSA/00002781/202101 - periodic safety update report single assessment
  245. Notice regarding equipments which are non notified but associated with notified devices
  246. Computerized Systems in Food Processing Industry
  247. Inactivated Chikungunya Vaccine in Single dose vial (0.5 ml).
  248. cdsco-disitamab-vedotinDisitamab Vedotin
  249. Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety…
  250. PSUSA/00010374/202101 - periodic safety update report single assessment
  251. European Medicines Agency conference on Environmental Risk Assessment for Human and…
  252. cdsco-prophylaxisPROphylaxis
  253. PSUSA-00002993-202109 - periodic safety update report single assessment
  254. Access Consortium Good Manufacturing Practice (GMP) Statement
  255. Paediatric Committee (PDCO): 18-21 July 2017
  256. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 May 2021
  257. cdsco-producttrastuzumabProducttrastuzumab
  258. Extract of the New Drugs and Clinical Trials Rules 2019 relevant to Ethics Committee for…
  259. PSUSA/00002329/202306 - periodic safety update report single assessment
  260. Committee for Proprietary Medicinal Products (CPMP) 15th plenary meeting
  261. Second meeting of the EMEA Human Scientific Committees' Working Party with with Patients'…
  262. Emtricitabine/Tenofovir disoproxil Zentiva
  263. Contacts at the European Medicines Agency
  264. PDCO: meeting archive 2012-2014
  265. Moxidectin-containing veterinary medicines used in cattle, sheep and horses - referral
  266. ema-aspaveliAspaveli
  267. Consultation on the Atypical Active Pharmaceutical Ingredients List
  268. cdsco-auxoraAuxora
  269. Modifications to templates (Paediatrics)
  270. An Endoscope Training Program? What’s the Deal?
  271. Corrigendum to Notice inviting Expression of Interest for development of Digital Drugs…
  272. Public consultation on the publication and access to clinical-trial data now closed
  273. Peptide Receptor Radionuclide Therapy (PRRT)
  274. PSUSA/00001783/201705 - periodic safety update report single assessment
  275. DR_ Draft_G.S.R. 686 (E) dt_25.09.2023_Inclusion of Oseltamivir and Zanamivir in Schedule…
  276. 21 CFR 1.4: Authority citations.
  277. 21 CFR 866.3930: Vibrio cholerae serological reagents.
  278. European Medicines Agency closed 20 May 2013
  279. Blue Guide: advertising and promoting medicines: Appendix 7 - Blue Guide
  280. PSUSA/00001849/202211 - periodic safety update report single assessment
  281. 21 CFR 862.1455: Lecithin/sphingomyelin ratio in amniotic fluid test system.
  282. Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
  283. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  284. EMEA-000063-PIP01-07-M01 - paediatric investigation plan
  285. May 22, 2024: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs…
  286. Guide to Incident Reporting for In-vitro Diagnostic Medical Devices
  287. Inclusion of Schedule H1 under the Drugs and Cosmetics Rules Dated 19.03.2014
  288. Renew: marketing authorisation for a human medicine
  289. ema-hexyonHexyon
  290. EMEA-003281-PIP01-22 - paediatric investigation plan
  291. UPDATE on Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of…
  292. Management Board meeting: 17 - 18 December 2025
  293. Regulatory information - EMA encourages companies to submit quality type-I variations for…
  294. EU/3/18/2000 - orphan designation for treatment of glycogen storage disease type II…
  295. Notice regarding NABL accredited Drug Testing Laboratories and Manufacturing Units…
  296. ema-nonafactNonafact
  297. ema-fotivdaFotivda
  298. World Hepatitis Day – European Medicines Agency uses regulatory tools to facilitate…
  299. Proposed 'Herbal Substance Name' (AHS) application form
  300. ema-otezlaOtezla
  301. Committee for Advanced Therapies (CAT): 15-17 February 2017
  302. Team-NB-byFewFacts-and-Numbers-Strategy-20241213
  303. 21 CFR 876.5280: Implanted mechanical/hydraulic urinary continence device.
  304. cfr-21-cfr-806-2-definitions21 CFR 806.2: Definitions.
  305. EU/3/01/072 - orphan designation for treatment of off-periods in Parkinson's disease not…
  306. Robert Sayle: Let’s Talk about New Wireless Security Certifications
  307. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.3) Regulations…
  308. 21 CFR 870.2220: Adjunctive hemodynamic indicator with decision point.
  309. Test method: UPLCC01 - Cannabinoids
  310. Periodic safety update reports (PSURs)
  311. EU/3/19/2183 - orphan designation for treatment of WHIM syndrome
  312. 21 CFR 73.3106: 1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone copolymers.
  313. 21 CFR 3.8: Letter of designation.
  314. European Immunization Week 2019: statement by Executive Director Guido Rasi
  315. AAMI’s Amanda Benedict Honored by Society for Standardization Professionals
  316. European Risk Management Strategy: 2008-2009 work programme adopted
  317. So, You’re Joining AAMI… But What Kind of Member Should You Be?
  318. 21 CFR 890.5225: Powered patient rotation bed.
  319. New treatment for rare white blood cell cancer
  320. UPDATED INFORMATION: October 17 – 19, 2022: Hearing Announcement involving the Obstetrics…
  321. ENCePP: 10 years for excellence in medicines safety
  322. ema-nobilis-influenza-h7n1Nobilis Influenza H7N1
  323. EMEA-001883-PIP03-17 - paediatric investigation plan
  324. NeeS AU module 1 and regional information
  325. ema-ilarisIlaris
  326. EMEA-002428-PIP01-18 - paediatric investigation plan
  327. Regulatory changes for software based medical devices
  328. 21 CFR 12.45: Notice of participation.
  329. Robert Sayle: What Does Cybersecurity Need? Supplicants
  330. EMEA-000764-PIP01-09 - paediatric investigation plan
  331. Hippocastani semen - herbal medicinal product
  332. PSUSA/00002078/201711 - periodic safety update report single assessment
  333. 21 CFR 803.23: Where can I find information on how to prepare and submit an MDR in…
  334. EMEA-001519-PIP01-13 - paediatric investigation plan
  335. ARGB Appendix 11 - Guidance on TGO 107: Standard for Biologicals - Labelling Requirements
  336. Inspection of Biological Drug Products
  337. Committee for Herbal Medicinal Products (HMPC): 30 June-1 July 2014
  338. ema-vijoiceVijoice
  339. NMPA Issued the Announcement on Issues Concerning the Import of Reference Drugs for…
  340. PSUSA/00010224/201708 - periodic safety update report single assessment
  341. Clinical efficacy and safety: anti-infectives for systemic use
  342. Andreas Pott appointed Deputy Executive Director of European Medicines Agency
  343. Ibuprofen / Famotidine - paediatric investigation plan
  344. EU/3/15/1477 - orphan designation for treatment of pancreatic cancer
  345. cdsco-c21C21
  346. Guidance Document: Guidance on supporting evidence to be provided for new and amended…
  347. Cloud-Based Cybersecurity Risks Among Top Health Technology Hazards for 2023
  348. 21 CFR 876.4020: Fiberoptic light ureteral catheter.
  349. Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin…
  350. EU/3/14/1270 - orphan designation for treatment of biliary tract cancer
  351. ACMD meeting statement, Meeting 33, 1 June 2017
  352. ema-tecovirimat-sigaTecovirimat SIGA
  353. cdsco-ixekizumabIxekizumab
  354. DR_G.S.R. 607(E) dt_28.08.2009_corregendum of GSR 46(E) dt 22.01.2009
  355. Recommendation-NB-MED-2.5.2 rec 2 Reporting of design changes and changes of the quality…
  356. ema-trogarzoTrogarzo
  357. 21 CFR 864.1866: Lynch syndrome test systems.
  358. EMEA-000120-PIP01-07-M05 - paediatric investigation plan
  359. Safety warning for SGLT2 Inhibitors
  360. Capsicum/capsaicin containing herbal medicinal products - Scientific guideline
  361. cdsco-aur103-calciuminAUR103 Calciumin
  362. ACB meeting statement, Meeting 17, 25 February 2021
  363. Global regulators strengthen efforts to ensure continuous availability of safe and…
  364. triptyline IP + Methylcobalamin IP + Pregabalin IP (SR) Tablets (Phase III)
  365. Concept paper for the revision of residues guidelines to align with the definitions for…
  366. GN 21-R4.2 Guidance on Change Notification for Registered Medical Devices [ARCHIVED on 31…
  367. Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and…
  368. 21 CFR 886.5870: Low-vision telescope.
  369. 21 CFR 890.5180: Manual patient rotation bed.
  370. 21 CFR 810.14: Cease distribution and notification or mandatory recall strategy.
  371. 21 CFR 74.2340: FD&C Red No. 40.
  372. 21 CFR 1.1320: When must I assign traceability lot codes to foods on the Food Traceability…
  373. ema-avelox-referralAvelox - referral
  374. EMA considerations on COVID-19 vaccine approval - Scientific guideline
  375. October 22, 2020: Patient Engagement Advisory Committee Meeting Announcement - 10/22/2020
  376. Paediatric Committee (PDCO): 22-25 July 2025
  377. ema-aluviaAluvia
  378. Linco-Spectin 100 and associated names - referral
  379. EU/3/23/2879 - orphan designation for treatment of insulinoma
  380. Bedaquiline, Rifampicin, Clofazimine, Dapsone
  381. PSUSA/00001766/202004 - periodic safety update report single assessment
  382. 21 CFR 1.368: What are the compliance dates for this subpart?
  383. Cholera Vaccine (Inactivated, Oral), I.P.
  384. ema-lymprevaLympreva
  385. 21 CFR 3.7: Request for designation.
  386. 21 CFR 890.3700: Nonpowered communication system.
  387. Registration opens for workshop on EMA-HTA parallel scientific advice in drug development
  388. ema-tachosilTachoSil
  389. Inactivated Hepatitis A Vaccine (Adsorbed
  390. ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug…
  391. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18…
  392. 21 CFR 888.3540: Knee joint patellofemoral polymer/metal semi-constrained cemented…
  393. EU/3/10/781 - orphan designation for treatment of glioma
  394. PSUSA/00010289/201702 - periodic safety update report single assessment
  395. cdsco-pasireotidestudyPasireotidestudy
  396. PSUSA/00010631/202112 - periodic safety update report single assessment
  397. June 9, 2016: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement…
  398. Monkeypox: EMA starts review for Imvanex
  399. Tasigna - withdrawal of application for variation to marketing authorisation
  400. EMEA-002010-PIP01-16-M03 - paediatric investigation plan
  401. Diflucan - Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be…
  402. ema-lydisilkaLydisilka
  403. Questions and answers: Article 13 referral procedures
  404. Guselkumab and Golimumab
  405. Notice regarding Evaluation of FDC by DTAB Sub-Committee which were ealier Considered as…
  406. PSUSA/00000745/201512 - periodic safety update report single assessment
  407. FDA Medical Device User Fees Increase for 2024
  408. cdsco-intravitreal-opt-302Intravitreal OPT-302
  409. 21 CFR 864.8625: Hematology quality control mixture.
  410. Workshop on transparency and access to documents of the EMEA of the 30 October 1997
  411. EU/3/23/2844 - orphan designation for treatment of myelofibrosis
  412. FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two…
  413. Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
  414. 21 CFR 74.3708: D&C Yellow No. 8.
  415. ema-raligizeRaligize
  416. Clopidogrel Orion - referral
  417. 21 CFR 26.45: Monitoring continued equivalence.
  418. 21 CFR 888.3330: Hip joint metal/metal semi-constrained, with an uncemented acetabular…
  419. ema-coagadexCoagadex
  420. Guidance for the use of medicinal cannabis for the prevention or management of nausea and…
  421. Cancer Medicines Forum: kick-off meeting
  422. FDA's Accreditation Scheme for Conformity Assessment (ASCA) Is Here to Stay
  423. Advance LTC Form(Related to Employees)
  424. 21 CFR 1.1435: What process applies to a petition requesting a waiver for a type of…
  425. EMEA-001214-PIP09-21-M01 - paediatric investigation plan
  426. GlaxoSmithKline withdraws its application for an extension of the indication for Tyverb…
  427. EMEA-001472-PIP01-13 - paediatric investigation plan
  428. ema-iclusigIclusig
  429. Extra dose from vials of Comirnaty COVID-19 vaccine
  430. 21 CFR 862.1163: Cardiac allograft gene expression profiling test system.
  431. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22…
  432. 21 CFR 884.2980: Telethermographic system.
  433. Risk classification list of medical devices pertaining to Interventional Radiology
  434. PSUSA/00002610/201505 - periodic safety update report single assessment
  435. EU/3/23/2820 - orphan designation for treatment of glioma
  436. European Medicines Agency confirms positive benefit-risk balance of Protelos / Osseor, but…
  437. cdsco-dak539-pelabresibDAK539 (Pelabresib)
  438. eXtended EudraVigilance Medicinal Product Dictionary training course
  439. 21 CFR 862.1615: Pregnenolone test system.
  440. EMA recommends aligning doses of metamizole medicines and their use during pregnancy and…
  441. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  442. Drug Alert for the month of April 2018
  443. Core summary of product characteristics for human anti-D immunoglobulin for intravenous…
  444. EMEA-002303-PIP01-17-M03 - paediatric investigation plan
  445. EMEA-001357-PIP01-12-M02 - paediatric investigation plan
  446. Damaged or Worn Covers for Medical Bed Mattresses Pose Risk of Contamination and Patient…
  447. Public statement on the cessation of marketing of exubera (Insulin human)
  448. PSUSA/00010670/201808 - periodic safety update report single assessment
  449. European Medicines Agency (EMA) Healthcare Professionals' Working Party (HCPWP) meeting
  450. Modelling and simulation in the development and regulatory review of medicines
  451. Statement by Executive Director Guido Rasi in The Hague
  452. Guidance Document for obtaining Free sale certificate for licensed Medical Devices in…
  453. EU/3/22/2686 - orphan designation for treatment of amyotrophic lateral sclerosis
  454. Malvae folium - herbal medicinal product
  455. EU/3/14/1256 - orphan designation for treatment of Leber's congenital amaurosis
  456. Resolution No. (48) of 2020 On Medical Devices and Products’ Quality Control
  457. Gabapentin IP (as film coated tablets) + Duloxetine Hydrochloride IP eq. to Duloxetine (as…
  458. Paediatric Committee (PDCO): 23-26 May 2023
  459. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2014
  460. 21 CFR 864.5600: Automated hematocrit instrument.
  461. Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical…
  462. 21 CFR 878.4018: Hydrophilic wound dressing.
  463. ema-opfoldaOpfolda
  464. Committee for Proprietary Medicinal Products (CPMP) 10th plenary meeting
  465. NMPA Revises Package Insert of Docusate Sodium and Dantron Capsules
  466. Management Board meeting: 16-17 December 2020
  467. Application form for Special Consignment by a Product Registrant
  468. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29…
  469. 21 CFR 868.2385: Nitrogen dioxide analyzer.
  470. Clinical development of medicinal products intended for the treatment of chronic primary…
  471. 21 CFR 866.5950: Genetic health risk assessment system.
  472. EMEA-001743-PIP01-14 - paediatric investigation plan
  473. Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 February 2015
  474. Clinical efficacy and safety: biostatistics
  475. 21 CFR 892.1360: Radionuclide dose calibrator.
  476. EU/3/14/1408 - orphan designation for treatment of glioma
  477. 21 CFR 886.1390: Flexible diagnostic Fresnel lens.
  478. Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU
  479. EU/3/08/605 - orphan designation for treatment of spinal cord injury
  480. European Commission (EC) Decision Reliance Procedure
  481. Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
  482. EMEA-000309-PIP01-08-M07 - paediatric investigation plan
  483. Five additional countries to benefit from EU-US mutual recognition agreement for…
  484. Consultation on draft guideline on quality requirements for medical devices in combination…
  485. 21 CFR 862.1535: Ornithine carbamyl transferase test system.
  486. 21 CFR 876.2050: Prostate lesion documentation system.
  487. EU collaboration strengthens safety monitoring of medicines
  488. PIC/S GMP Guide (PE 009-17) Part I
  489. EU/3/14/1371 - orphan designation for treatment of systemic sclerosis
  490. Vanda Pharmaceuticals Ltd withdraws its marketing-authorisation application for Fanaptum…
  491. January 30.01.2013 (GSR 53 E)
  492. Control of the active substance in the finished product for immunological veterinary…
  493. EU/3/17/1867 - orphan designation for treatment of ornithine transcarbamylase deficiency
  494. 2026.05.22 G.S.R. 407(E)_Notification for Revision of testing fees under Schedule B and B1…
  495. Committee for medicinal products for veterinary use: Meeting of 14-15 May 2007
  496. Update on seasonal-influenza vaccines produced by Novartis Vaccines
  497. P/90/2010 - paediatric investigation plan
  498. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26…
  499. Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 November 2018
  500. 21 CFR 74.1261: D&C Orange No. 11.
  501. Organ(s) and tissue(s) Donor Form
  502. Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor…
  503. Tadalafil product-specific bioequivalence guidance
  504. Workshop on paediatric investigation plans in type-2 diabetes mellitus
  505. Sensing a Need, HTM Leader Develops the First CHTM Study Course
  506. Ulipristal acetate 5mg medicinal products - referral
  507. Resmetirom tablet 60mg,80mg & 100mg
  508. ema-inaqoviInaqovi
  509. Clascosterone cream 1% w/w
  510. AAMI BMET Apprenticeship Program Gains Valuable College Support
  511. ema-applying-for-sme-statusApplying for SME status
  512. EU/3/05/272 - orphan designation for treatment of acute myeloid leukaemia
  513. Celexa (citalopram hydrobromide)- Abnormal heart rhythms associated with high doses of…
  514. Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics…
  515. Non-clinical: pharmacology and safety pharmacology
  516. Ibuprofen, diphenhydramine hydrochloride - paediatric investigation plan
  517. Production and quality control of medicinal products derived by recombinant DNA technology…
  518. PSUSA/00000039/201902 - periodic safety update report single assessment
  519. cdsco-ianalumab-vay736ianalumab (VAY736)
  520. PSUSA/00010298/202203 - periodic safety update report single assessment
  521. Good laboratory practice (GLP) facilities: risk-based quality assurance: GLP quality…
  522. ema-fabhaltaFabhalta
  523. Committee for Orphan Medicinal Products: April 2005 meeting
  524. 21 CFR 872.6890: Intraoral dental wax.
  525. Ten years promoting high-quality scientific research in paediatric medicines
  526. Press Release: Exemption of the EU's regulatory control applicable to APIs exported from…
  527. Committee for Medicinal Products for Human Use (CHMP): 19-22 October 2015
  528. With Data Breaches on the Rise, Government Issues Ransomware Guidance
  529. PSUSA/00001500/201504 - periodic safety update report single assessment
  530. 2019.02.26_Final G.S.R. 153(E)_Date of implementation for G.S.R. 277(E) dated 23.03.2018
  531. ema-pegasysPegasys
  532. Clarification regarding import of non-drug / lab kits shipments related to clinical trial…
  533. EU/3/23/2839 - orphan designation for treatment of amyotrophic lateral sclerosis
  534. 21 CFR 874.3930: Tympanostomy tube with semipermeable membrane.
  535. EMEA-003308-PIP01-22 - paediatric investigation plan
  536. How tests and testing kits for coronavirus (COVID-19) work: Target Product Profile…
  537. Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 February 2020
  538. Gilenya - Safety review of a reported death after the first dose of Multiple Sclerosis…
  539. ema-arpraziquantelArpraziquantel
  540. EMEA-002818-PIP01-20 - paediatric investigation plan
  541. ema-zypadheraZypadhera
  542. 10th anniversary of European Medicines Agency's Patients' and Consumers' Working Party…
  543. Polycyclic Aromatic Hydrocarbons in herbal medicinal products/traditional herbal medicinal…
  544. Paediatric investigation plans: questions and answers
  545. 21 CFR 886.3920: Aqueous shunt.
  546. NPMA Announcement on Implementing the Application with Electronic Common Technical…
  547. The FDA Recommends Against Using Laserworld and Ray Technologies International Laser…
  548. Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical…
  549. PSUSA/00002977/201912 - periodic safety update report single assessment
  550. ema-lexylanLexylan
  551. How to draft a direct healthcare professional communication
  552. PSUSA/00003104/201705 - periodic safety update report single assessment
  553. EU/3/21/2424 - orphan designation for treatment of multiple myeloma
  554. Methysergide-containing medicines - referral
  555. Good Clinical Practice Inspectors Working Group
  556. European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No…
  557. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 March…
  558. cfr-21-cfr-17-3-definitions21 CFR 17.3: Definitions.
  559. EU/3/19/2212 - orphan designation for treatment of Friedreich’s ataxia
  560. Risk Evaluation and Mitigation Strategies (REMS) Reporting Inspections
  561. EMEA-003183-PIP02-22 - paediatric investigation plan
  562. cdsco-rc-form-10-checklistrc & form 10 checklist
  563. EMEA-002677-PIP01-19-M02 - paediatric investigation plan
  564. P/91/2010 - paediatric investigation plan
  565. EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing…
  566. Data requirements for vaccine antigen master files (VAMF) - Scientific guideline
  567. PSUSA/00002333/201608 - periodic safety update report single assessment
  568. 15th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
  569. cdsco-ipatasertibIpatasertib
  570. EU/3/07/520 - orphan designation for treatment of epithelial neoplasia of the vulva…
  571. 21 CFR 882.5800: Cranial electrotherapy stimulator.
  572. 21 CFR 14.27: Determination to close portions of advisory committee meetings.
  573. EMEA-002462-PIP01-18 - paediatric investigation plan
  574. Clarification for import of in Bulk form in Sutures
  575. Metformin Hydrochloride IP (As extended release) + Glimepiride IP + Dapagliflozin…
  576. ema-pioglitazone-krkaPioglitazone Krka
  577. Considerations on Development of Recombinant Virus Vaccines for Prevention of Infections
  578. Stability and traceability requirements for vaccine intermediates - Scientific guideline
  579. DEGLUSTEROL ON FASTING GLUCOSE
  580. Sitagliptin Phosphate Monohydrate IP equivalent to Sitagliptin + Pioglitazone…
  581. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 July 2014
  582. EU/3/17/1900 - orphan designation for treatment of myelodysplastic syndromes
  583. Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices
  584. Prohibits to Import, manufacture, sale, distribution and use in any food producing animal…
  585. 21 CFR 886.4570: Ophthalmic surgical marker.
  586. PSUSA/00002947/201912 - periodic safety update report single assessment
  587. EMEA-001569-PIP01-13 - paediatric investigation plan
  588. PSUSA/00010806/202010 - periodic safety update report single assessment
  589. ema-enjaymoEnjaymo
  590. 21 CFR 876.4770: Urethrotome.
  591. cdsco-evenamide2Evenamide2
  592. Invega - withdrawal of application for variation to marketing authorisation
  593. Third EMEA Workshop for Micro, Small and Medium-Sized Enterprises (SMEs), 'Focus on…
  594. Global regulators confirm good safety profile of COVID-19 vaccines
  595. cdsco-mepolizumabMepolizumab
  596. Clinical Trials Information System (CTIS): Walk-in clinic - April 2022
  597. Drug Alert list for month of January 2015
  598. European Medicines Agency confirms positive benefit-risk balance of somatropin-containing…
  599. ema-lysakareLysaKare
  600. Classification of IVD medical devices
  601. Bisoprolol fumarate / acetylsalicylic acid - paediatric investigation plan
  602. ema-mpox-monkeypoxMpox (monkeypox)
  603. ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for primary…
  604. cdsco-belantamab-mafodotinBelantamab mafodotin
  605. PYX-201 Solution for Injection/Infusion, 100mg/6.67 mL (15mg/mL)
  606. Committee for Advanced Therapies (CAT): 18-20 March 2020
  607. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2022
  608. PSUSA/00001795/201505 - periodic safety update report single assessment
  609. European Medicines Agency releases for public consultation its draft policy on the…
  610. Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 April 2018
  611. ema-gastromotalGastromotal
  612. ema-equidacentEquidacent
  613. EMEA-000852-PIP01-10-M01 - paediatric investigation plan
  614. Medical devices: get regulatory advice from the MHRA
  615. ema-horse-allo-20Horse Allo 20
  616. EMEA-001136-PIP02-19-M01 - paediatric investigation plan
  617. 15th Joint European Medicines Agency/European network for Health Technology Assessment…
  618. Guidance on air freight of medicines: Guidance on air freight
  619. EU/3/21/2483 - orphan designation for treatment of partial deep dermal and full thickness…
  620. Standard Operating Procedure PIC/S Inspection Report Format
  621. Guideline on good pharmacovigilance practices (GVP): module xv - safety communication (rev…
  622. 21 CFR 882.5225: Implanted malleable clip.
  623. 21 CFR 862.1235: Cyclosporine test system.
  624. EMEA-002696-PIP03-22 - paediatric investigation plan
  625. Refusal of orphan designation for treatment of partial deep dermal and full-thickness…
  626. PSUSA/00010414/201909 - periodic safety update report single assessment
  627. Paediatric Committee (PDCO): 7-9 September 2011
  628. EMEA-000281-PIP01-08-M02 - paediatric investigation plan
  629. Submission dossier checklist for prescription medicines
  630. Industry stakeholder meeting on Brexit and operation of centralised procedure for human…
  631. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13…
  632. EMEA-002077-PIP01-16 - paediatric investigation plan
  633. 21 CFR 892.1380: Nuclear flood source phantom.
  634. cdsco-cpi-613CPI-613
  635. EudraVigilance training on electronic reporting of ICSRs in the EEA
  636. ema-insumanInsuman
  637. Public Notice on PRO Schedule
  638. PSUSA/00002174/202102 - periodic safety update report single assessment
  639. DR_G.S.R. 431(E) dt_30.06.2005_Amendments in Schedule M
  640. EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19…
  641. cdsco-ophthalmic-orderOPHTHALMIC ORDER
  642. Regulatory information – 1.7% and 1.6% increase of pharmacovigilance fees from 1 November…
  643. Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply…
  644. 21 CFR 890.3690: Powered wheeled stretcher.
  645. ema-vidazaVidaza
  646. Medicines for human use under evaluation 2020–2018
  647. Health (Miscellaneous Provisions) Act 2017 [Establishment of the HPRA]
  648. ema-dogstemDogStem
  649. EU/3/11/884 - orphan designation for prevention of ischaemia/reperfusion injury associated…
  650. ema-aftovaxpur-doeAftovaxpur DOE
  651. Workshop on the challenges for the approval of anti-cancer immunotherapeutic drugs
  652. New medicine for rare bone disease
  653. ema-versican-plus-pi-l4Versican Plus Pi/L4
  654. EU/3/11/940 - orphan designation for treatment of polycythaemia vera
  655. EU/3/12/1067 - orphan designation for treatment of mercury toxicity
  656. ema-reconcileReconcile
  657. PSUSA/00001266/201608 - periodic safety update report single assessment
  658. EMEA-003068-PIP01-21 - paediatric investigation plan
  659. FDA Warns Against Use of Teething Necklaces, Bracelets, and Other Jewelry Marketed for…
  660. Anagrelide Viatris (previously Anagrelide Mylan)
  661. Sambuci flos - herbal medicinal product
  662. EU/3/24/2948 - orphan designation for treatment of mitochondrial neurogastrointestinal…
  663. ISO 14698 or EN 17141: Is There a Choice for Cleanroom Compliance?
  664. European Medicines Agency implements internal reorganisation
  665. 21 CFR 878.4550: Autofluorescence detection device for general surgery and dermatological…
  666. Listed medicine presentation and labels
  667. EU/3/07/432 - orphan designation for treatment of graft-versus-host disease
  668. Adjusted fees for applications to European Medicines Agency from 1 April 2013
  669. EMA/131957/2023 - periodic safety update report single assessment
  670. European Medicines Agency recommends contraindication for Regranex in patients with any…
  671. mhra-electrosurgery-top-tipsElectrosurgery: top tips
  672. 21 CFR 864.7425: Carboxyhemoglobin assay.
  673. ACMD meeting statement, Meeting 25, 26 February 2016
  674. PSUSA/00000109/201603 - periodic safety update report single assessment
  675. Paediatric Committee (PDCO): 12-14 August 2015
  676. EMEA-002338-PIP02-18 - paediatric investigation plan
  677. Alan Lipschultz: HTM Wiki Needs Data, Participants
  678. ema-synagisSynagis
  679. PSUSA/0009162202103 - periodic safety update report single assessment
  680. Top 10 Sterilization News Updates for 2024
  681. Interstate Carriers and Support Facilities (4/95)
  682. ema-prograf-referralPrograf - referral
  683. PSUSA/00000546/202206 - periodic safety update report single assessment
  684. 21 CFR 862.3560: Lithium test system.
  685. EU/3/22/2683 - orphan designation for treatment of amyotrophic lateral sclerosis
  686. Meeting highlights from the Paediatric Committee: 12 - 14 March 2008
  687. 21 CFR 892.5930: Therapeutic x-ray tube housing assembly.
  688. cdsco-pemafibratePemafibrate
  689. FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for…
  690. Cox-2 selective inhibitors and non-steroidal anti-inflammatory drugs’ (NSAIDs)…
  691. ema-pyramaxPyramax
  692. SAR webinar slides_24mar22
  693. EMEA-002700-PIP01-19-M01 - paediatric investigation plan
  694. Fifth EMA/HMA Big Data Stakeholder Forum
  695. EU/3/01/038 - orphan designation for treatment of severe combined immunodeficiency…
  696. URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component…
  697. PSUSA/00002927/201507 - periodic safety update report single assessment
  698. EU/3/10/787 - orphan designation for treatment of mantle cell lymphoma
  699. FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects…
  700. E-Submission Guide for GMD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R4…
  701. Ocaliva - direct healthcare professional communication (DHPC)
  702. EMEA-001835-PIP01-15-M05 - paediatric investigation plan
  703. Pneumococcal (Polysaccharide Conjugate Vaccine (14-Valent)
  704. Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 May 2010
  705. EU/3/06/388 - orphan designation for treatment of cancers of the biliary tree
  706. The annual European Medicines Agency review of the year and outlook for 2016
  707. EMEA-001910-PIP03-20-M01 - paediatric investigation plan
  708. Voices of HTM: Mike Powers
  709. cdsco-20142014
  710. ema-ozawadeOzawade
  711. New medicine for multiple sclerosis
  712. PSUSA/00002458/201607 - periodic safety update report single assessment
  713. Remembering Fenil Sutaria
  714. October 24.10.2013 GSR 703(E)
  715. ema-onuregOnureg
  716. Administration and Corporate Management
  717. Quality: Quality by Design (QbD)
  718. FDA Increases User Fees for 2021
  719. Launching of additional Forms on National Single Window System NSWS Portal
  720. EU/3/14/1349 - orphan designation for treatment of mucopolysaccharidosis type I
  721. ema-equioxxEquioxx
  722. Registration of in vitro diagnostic devices with expiring CE certificates
  723. Chikungunya vaccine (Inactivated)
  724. Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 November 2023
  725. ema-diotop-capsules-referralDiotop capsules - referral
  726. European Medicines Agency public statement on Leflunomide (Arava) - Severe and serious…
  727. Points to Consider for Ensuring the Reliability of Post-marketing Database Study for…
  728. ema-fertavidFertavid
  729. EU/3/06/403 - orphan designation for treatment of neonatal brain injury
  730. Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2016
  731. Product Quality Reviews (PQRs) for listed and complementary medicines
  732. Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety…
  733. Medical Device Alert date 21 June 2022
  734. ema-how-to-find-usHow to find us
  735. TREAT-NMD workshop on the development of antisense oligonucleotide therapies for Duchenne…
  736. 21 CFR 13.10: Members of a Board.
  737. 21 CFR 801.50: Labeling requirements for stand-alone software.
  738. EMEA-003091-PIP01-21 - paediatric investigation plan
  739. AS F0021.1.001: Appeals Flowchart
  740. EMEA-000987-PIP01-10-M04 - paediatric investigation plan
  741. Pregabalin IP + Duloxetine Hydrochloride IP eq. to Duloxetine (as delayed release pellets)…
  742. Guidance Document GD211: Guidance on the Content of Quality Management System audit…
  743. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April…
  744. Advanced therapy medicinal products: regulation and licensing in UK
  745. Committee for Medicinal Products for Human Use (CHMP): 22-25 June 2015
  746. PSUSA/00000230/201602 - periodic safety update report single assessment
  747. Arexvy - opinion on variation to marketing authorisation
  748. cdsco-circularCircular
  749. Ch. 8 - Emergency Procedures
  750. Specificaiton and Criteria for Acceptance_bood glucose test strip
  751. Regulatory update - EMA encourages companies to submit type I variations for 2017 by end…
  752. GN-21-R4.9 Guidance on Change Notification for Registered MD [ARCHIVED on 06 Mar 2023]…
  753. cdsco-intp24-against-avastinINTP24 Against Avastin®
  754. ema-abecmaAbecma
  755. Inaugural meeting of the Committee for Orphan Medicinal Products
  756. Notice regarding Approved panel of experts for the Subject Expert Committees
  757. EMA and FDA reinforce collaboration on patient engagement
  758. American Medical Association Elects Jesse Ehrenfeld, MD, MPH, to Top Spot
  759. Global regulators agree on key principles on adapting vaccines to tackle virus variants
  760. cdsco-roxadustatRoxadustat
  761. Selatogrel 16 mg/0.5mL aqueous solution
  762. Pre-submission Advice & Support
  763. EU/3/14/1288 - orphan designation for treatment of primary sclerosing cholangitis
  764. Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin…
  765. Insulin Injection, Biphasic Isophane IP /Ph. Eur. 100 IU/ml in 3 ml cartridge (containing…
  766. Classification of medical device pertaining to Cardiovascular under the provisions of…
  767. 21 CFR 26.70: Conformity assessment bodies.
  768. European Medicines Agency closed 17-18 May 2012
  769. EU/3/09/649 - orphan designation for treatment of Hodgkin's lymphoma
  770. cfr-21-cfr-60-1-scope21 CFR 60.1: Scope.
  771. Committee for Orphan Medicinal Products (COMP): 18-20 March 2025
  772. EMEA-001679-PIP01-14-M03 - paediatric investigation plan
  773. 21 CFR 888.3150: Elbow joint metal/polymer constrained cemented prosthesis.
  774. EMA website briefly unavailable on 25 July
  775. PSUSA/00002215/201704 - periodic safety update report single assessment
  776. Development and manufacture of lentiviral vectors - Scientific guideline
  777. FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much…
  778. NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition…
  779. Regulations for Management of Medical Device Safety Surveillance, Medical Device Safety…
  780. EMA to relocate to Amsterdam, the Netherlands
  781. PSUSA/00001620/201911 - periodic safety update report single assessment
  782. BI 456906 solution for injection 0.5 ml
  783. PSUSA/00002229/202104 - periodic safety update report single assessment
  784. PSUSA/00001744/202103 - periodic safety update report single assessment
  785. ema-silapoSilapo
  786. ema-comp-documentsCOMP Documents
  787. Telehealth on a Shoestring: Lessons from COVID-19
  788. PSUSA/00002649/201705 - periodic safety update report single assessment
  789. MHRA phase I accreditation scheme
  790. Glycopyrronium IP eq. to Glycopyrronium 25mcg + Indacaterol Maleate eq. to Indacaterol…
  791. TSE requirements for imported unlicensed human medicines
  792. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14…
  793. CDRH Reorganization Heralds New Focus on Medical Device Standards
  794. EU/3/16/1823 - orphan designation for treatment of sudden sensorineural hearing loss
  795. Guidance for individual laboratories for transfer of quality control methods validated in…
  796. 21 CFR 801.405: Labeling of articles intended for lay use in the repairing and/or…
  797. EU/3/22/2665 - orphan designation for treatment of pyridoxal 5'‐phosphate homeostasis…
  798. Patients’ and healthcare professionals’ organisations updated on EMA’s response to…
  799. EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19
  800. EMEA-002070-PIP01-16-M07 - paediatric investigation plan
  801. 2nd February 2007 (G.S.R. 63(E))
  802. cdsco-fenebrutinibFenebrutinib
  803. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  804. 21 CFR 864.9750: Heat-sealing device.
  805. Paving the way towards coordinated clinical trials in public health emergencies in the EU
  806. Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting…
  807. Chapter 8 - Labelling Guidance Northern Ireland: Chapter 8 - Labelling Guidance - NI
  808. Dydrogesterone Sustained Release Tablet 30mgCT/SND/09/2023
  809. The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS…
  810. EU/3/21/2546 - orphan designation for treatment of acute lymphoblastic leukaemia
  811. PSUSA/00002925/202305 - periodic safety update report single assessment
  812. 21 CFR 862.2920: Plasma viscometer for clinical use.
  813. Vaccinii macrocarpi fructus - herbal medicinal product
  814. Submission of notarized/apostilled documents for import of medical device and in-vitro…
  815. cdsco-opt-302OPT-302
  816. PSUSA/00002698/201501 - periodic safety update report single assessment
  817. FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel)…
  818. Important change to heparin container labels to clearly state the total drug strength
  819. Favipiravir tablet 200 mg/400 mg/800 mg
  820. Tiliae flos - herbal medicinal product
  821. EU/3/19/2165 - orphan designation for treatment of citrullinaemia type 1
  822. ema-toltrazuril-referralToltrazuril - referral
  823. European Medicines Agency to push ahead in 2014 towards publication and access to clinical…
  824. William Hyman: New Warnings and Old Users
  825. 21 CFR 73.3129: Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino…
  826. ema-balversaBalversa
  827. Mary Logan: Humidity in the OR and the Value of Systems Engineering
  828. PSUSA/00001740/201809 - periodic safety update report single assessment
  829. Melissa Kozak: Put Device Users First with Human Factors-Informed Procurement
  830. EU agencies to advise on risks from phenylbutazone in horsemeat
  831. 21 CFR 864.5425: Multipurpose system for in vitro coagulation studies.
  832. Checklist for Form MD-12 IVD (Application for licence to manufacture medical devices for…
  833. European Medicines Agency clarifies rules on fees
  834. EU/3/03/148 - orphan designation for treatment of renal-cell carcinoma
  835. Drug Alert list for month of June 2021
  836. Experts from AAMI Fall Sterilization Standards Week 2022 Reveal Key Insights
  837. Strengthening EU-US cooperation in medicine inspections
  838. 21 CFR 810.12: Written request for review of cease distribution and notification order.
  839. Rimegepant Oral disintegrating tablets (ODT) 75 mg
  840. 21 CFR 862.1580: Phosphorus (inorganic) test system.
  841. ema-luverisLuveris
  842. 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and…
  843. Approval of GxP documents when working from home during the coronavirus (COVID-19)…
  844. PSUSA/00002233/201701 - periodic safety update report single assessment
  845. After 35 Years, Standards Champion and Industry Expert Joe Lewelling Has Left the Building
  846. EU/3/17/1961 - orphan designation for treatment of acute myeloid leukaemia
  847. PSUSA/00001938/201905 - periodic safety update report single assessment
  848. European Medicines Agency recommends changes in the product information for Protelos /…
  849. Rationalization of descriptions in the specification column in approval application forms…
  850. 21 CFR 890.3175: Flotation cushion.
  851. EU/3/15/1529 - orphan designation for treatment of fragile X syndrome
  852. 21 CFR 866.3210: Endotoxin assay.
  853. Creating a ‘Culture that Rocks’ to Earn Loyalty
  854. Dapagliflozin + Teneligliptin Hydrobromide Hydrate IP eq. to Dapagliflozin (Phase III)
  855. ema-fortacinFortacin
  856. COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
  857. (In Japanese)Procedures for Developing Post-marketing Study Plan
  858. EU/3/13/1181 - orphan designation for treatment of eosinophilic oesophagitis
  859. Recommendation-NB-MED-2_5_2-1_rev4 Subcontracting – QS related
  860. Cydectin TriclaMox - referral
  861. Guidance to market authorization holders on issuing health product risk communications
  862. ema-fortovaseFortovase
  863. 2nd February 2007(G.S.R 62(E))
  864. EMEA-002908-PIP01-20 - paediatric investigation plan
  865. Xlucane versus Lucentis®
  866. Aide-Memoire on Medicinal Gases
  867. RESOLUTION RDC NO. 185, 22 OCTOBER 2001
  868. Provisions for Drug Insert Sheets and Labels
  869. EMEA-000689-PIP01-09-M11 - paediatric investigation plan
  870. ema-circomaxCircoMax
  871. Drug Alert list for month of February 2023 (Revised)
  872. POZELIMAB AND CEMDISIRAN
  873. EU/3/12/1037 - orphan designation for treatment of multiple myeloma
  874. Scientific Advice Working Party
  875. PSUSA/00002156/201508 - periodic safety update report single assessment
  876. EU/3/18/2021 - orphan designation for prevention of haemolytic uraemic syndrome
  877. EMEA Management Board considers the Agency's road map to 2010 and approves transparency…
  878. EU/3/23/2838 - orphan designation for treatment of Duchenne muscular dystrophy
  879. EU-US mutual recognition of inspections of medicines manufacturers enters operational…
  880. AAMI Mourns the Loss of Industry Leader Stanley Wallace Weitzner
  881. PSUSA/00000179/202110 - periodic safety update report single assessment
  882. EU/3/17/1967 - orphan designation for treatment of congenital adrenal hyperplasia
  883. EU/3/11/925 - orphan designation for treatment of hypercortisolism (Cushing's syndrome) of…
  884. EMEA-001783-PIP02-15 - paediatric investigation plan
  885. Potential risk of neurodevelopmental disorders in children born to men treated with…
  886. QA on PIC/S GDP Guide (PE 011-1)
  887. EU/3/08/564 - orphan designation for treatment of cystic fibrosis
  888. 21 CFR 868.5600: Venturi mask.
  889. EMEA-000347-PIP01-08-M06 - paediatric investigation plan
  890. First EMEA Workshop on Advanced Therapy Medicinal Products (ATMPs)
  891. EU/3/16/1771 - orphan designation for treatment of glycogen storage disease type Ia
  892. EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated
  893. Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders…
  894. 21 CFR 872.4840: Rotary scaler.
  895. EU/3/02/117 - orphan designation for treatment of peritumoral oedema derived from brain…
  896. EMEA-002120-PIP01-17 - paediatric investigation plan
  897. 21 CFR 868.1170: Indwelling blood hydrogen ion concentration (pH) analyzer.
  898. Strontium ranelate - paediatric investigation plan
  899. Mastering HTM Accreditation Compliance: Stress Less, Achieve More
  900. EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19
  901. EMEA-002948-PIP01-20 - paediatric investigation plan
  902. ema-calcitonins-referralCalcitonins - referral
  903. EMEA-001198-PIP02-16 - paediatric investigation plan
  904. 21 CFR 864.5240: Automated blood cell diluting apparatus.
  905. Classification of Medical Devices Pertaining to ENT under the Provisions of Medical…
  906. Sennae fructus - herbal medicinal product
  907. cfr-21-cfr-1-71-definitions21 CFR 1.71: Definitions.
  908. Points to Consider for Reducing Total Review Time for New Drug Applications
  909. 21 CFR 890.1385: Diagnostic electromyograph needle electrode.
  910. ema-cisapride-referralCisapride - referral
  911. PSUSA/00010525/201704 - periodic safety update report single assessment
  912. PSUSA/00010806/202310 - periodic safety update report single assessment
  913. 21 CFR 876.5090: Suprapubic urological catheter and accessories.
  914. EU/3/05/275 - orphan designation for bronchopulmonary dysplasia in premature neonates of…
  915. UPDATED PUBLIC PARTICIPATION INFORMATION: September 13, 2023: Cardiovascular and Renal…
  916. EU/3/21/2404 - orphan designation for treatment of leishmaniasis
  917. Harvoni recommended for the treatment of chronic hepatitis C
  918. Meeting Notice for medical devices and diagnostics stakeholders
  919. EU/3/10/814 - orphan designation for treatment of von Willebrand disease
  920. Sampling and testing for listed and complementary medicines
  921. European Medicines Agency's Management Board welcomes new civil-society members
  922. Pharmacovigilance: Regulatory and procedural guidance
  923. Signed Request form for Named-Patient Application Type
  924. ema-paroxetine-referralParoxetine - referral
  925. Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised…
  926. Adverse reactions, medical device incidents and health product recalls in Canada: 2019…
  927. 21 CFR 1.635: What if I want to voluntarily relinquish recognition or do not want to renew…
  928. European network of paediatric research at the European Medicines Agency (Enpr-EMA)…
  929. PF-06741086 (Marstacimab) 150mg/mL Solution for Injection
  930. Guideline for Clinical Evaluation of Diagnostic Radiopharmaceuticals
  931. Meningitis - Patient Factsheet
  932. Committee for veterinary medicinal products: 66th meeting
  933. 21 CFR 880.5960: Lice removal kit.
  934. Drug Alert list for month of August 2014
  935. Combination: Species amarae - herbal medicinal product
  936. Merck Sharp & Dohme (Europe), Inc. withdraws its marketing authorisation application for…
  937. New HTM Guidance Covers Compliance and Recognition “From the Basement to the Board Room”
  938. Bristol-Myers Squibb Pharma EEIG withdraws its marketing authorisationapplication for…
  939. PSUSA/00002910/201801 - periodic safety update report single assessment
  940. Threat Modeling and Penetration Testing for Cybersecurity
  941. 21 CFR 868.5955: Intermittent mandatory ventilation attachment.
  942. Standards of Service Fees for Application Review of Human Organ, Standards of Service Fees…
  943. 21 CFR 868.5115: Device to relieve acute upper airway obstruction.
  944. Clinical efficacy and safety: blood and blood-forming organs
  945. EU/3/24/2934 - orphan designation for treatment of pulmonary alveolar proteinosis
  946. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Pioglitazone Hydrochloride IP…
  947. ema-pegintronPegIntron
  948. Lidocaine/tetracaine - paediatric investigation plan
  949. 21 CFR 73.75: Canthaxanthin.
  950. Micro, small and medium-sized-enterprise (SME) workshop: Focus on chemistry, manufacturing…
  951. cdsco-lipidolLipidol
  952. Committee for Advanced Therapies (CAT): 5-7 December 2018
  953. Probiotic Supplementation lactic acid bacteria and Bifidobacteria, namely, L. Plantarum…
  954. European Medicines Agency signs lease for new office space
  955. 21 CFR 882.1525: Tuning fork.
  956. EMA virtual conference: 25 years of advancing public and animal health
  957. 21 CFR 886.1200: Optokinetic drum.
  958. Committee for Orphan Medicinal Products - September 2007 Meeting
  959. EU/3/02/119 - orphan designation for treatment of glioma
  960. 21 CFR 880.6025: Absorbent tipped applicator.
  961. PSUSA/00000628/202211 - periodic safety update report single assessment
  962. PSUSA/00001848/201712 - periodic safety update report single assessment
  963. ema-truvelog-mix-30Truvelog Mix 30
  964. Methodology Working Party Interested Parties Meeting
  965. EU/3/10/765 - orphan designation for treatment of mastocytosis
  966. 21 CFR 10.31: Citizen petitions and petitions for stay of action related to abbreviated…
  967. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29…
  968. August 30.08.2013 GSR 589 (E)
  969. PSUSA/00010381/201604 - periodic safety update report single assessment
  970. cdsco-vaporized-cannabinoidsvaporized cannabinoids
  971. Fluticasone Furoate 100mcg + Glycopyrronium Bromide Ph. Eur eq. to Glycopyrronium 50mcg +…
  972. EMA regular press briefing on COVID-19
  973. NMPA Issued the Guidelines for the Verification of Medical Device Registration Quality…
  974. Use of recovered/recycled solvents in the manufacture of herbal preparations for use in…
  975. European Surveillance of Veterinary Antimicrobial Consumption stakeholders meeting
  976. Clinical investigation of medicinal products in the treatment of peripheral-arterial…
  977. PRAC recommends new measures to avoid dosing errors with methotrexate
  978. DR_G.S.R. 445(E) dt_30.04.1992_Substitution Rule 3A_functions of laboratories in respect…
  979. 21 CFR 17.17: Summary decisions.
  980. 21 CFR 73.3120: 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.
  981. How to submit a custom-made medical device and patient-matched medical device notification
  982. ema-human-medicinesHuman Medicines
  983. PSUSA/00001491/201501 - periodic safety update report single assessment
  984. PSUSA/00003002/202306 - periodic safety update report single assessment
  985. ema-intelenceIntelence
  986. Lovenox and associated names - referral
  987. PSUSA/00001270/201704 - periodic safety update report single assessment
  988. Notice regarding Gelatin Capsules with cellulose
  989. Classification in IVD medical devices under the provision of MD Rules 2017
  990. NMPA Issued the Administrative Measures for Sampling Inspection of Medical Device Quality
  991. August 2, 2017: Meeting of the Arthritis Advisory Committee Meeting Announcement…
  992. EU/3/23/2841 - orphan designation for treatment of lymphatic malformations
  993. EU/3/21/2500 - orphan designation for treatment of megalencephalic leukoencephalopathy…
  994. FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients…

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