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Global regulations and guidance

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

  1. EU/3/17/1932 - orphan designation for treatment of Prader-Willi syndrome
  2. ema-cavoleyCavoley
  3. ema-jalraJalra
  4. Committee for Orphan Medicinal Products (COMP): 12-13 May 2015
  5. EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU
  6. 21 CFR 862.2750: Pipetting and diluting system for clinical use.
  7. 21 CFR 872.3150: Articulator.
  8. PSUSA/00002203/201504 - periodic safety update report single assessment
  9. 21 CFR 866.5540: Immunoglobulin G (Fd fragment specific) immunological test system.
  10. EU/3/22/2635 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  11. EMEA-002705-PIP03-20 - paediatric investigation plan
  12. AEMS guidance for sponsors
  13. FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and…
  14. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  15. 21 CFR 884.5960: Genital vibrator for therapeutic use.
  16. 21 CFR 884.5940: Powered vaginal muscle stimulator for therapeutic use.
  17. WD1905 Tablets with SINEMET
  18. Zypadhera - direct healthcare professional communication (DHPC)
  19. ADHD - Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity…
  20. PSUSA/00000850/202312 - periodic safety update report single assessment
  21. Medical Angiography X-ray Machine approved for marketing
  22. EU/3/22/2597 - orphan designation for treatment of primary biliary cholangitis
  23. cdsco-selpercatinibSelpercatinib
  24. FDA recommends health care professionals discuss naloxone with all patients when…
  25. EMEA-000367-PIP01-08-M08 - paediatric investigation plan
  26. FDA Says It Lacks Regulatory Authority to Continue Software Medical Device…
  27. EMEA-002775-PIP01-20 - paediatric investigation plan
  28. Oral Pharmacokinetics and Safety of TRC041266 Powder with TRC4186 Tablet
  29. 21 CFR 888.3535: Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated…
  30. Acting as a Responsible Person (import)
  31. Committee for veterinary medicinal products: 77th meeting
  32. EMEA-003158-PIP01-21 - paediatric investigation plan
  33. Webinars: information on how to make submissions to the MHRA
  34. Pharmacovigilance fees: questions and answers
  35. Opening up clinical data on new medicines
  36. cdsco-clindamycin-1Clindamycin 1%
  37. tga-biopharmaceutic-studiesBiopharmaceutic studies
  38. EU/3/16/1808 - orphan designation for treatment of systemic sclerosis
  39. EMEA-002947-PIP01-20 - paediatric investigation plan
  40. EMEA-002199-PIP01-17 - paediatric investigation plan
  41. Second EMA-EFPIA annual bilateral meeting
  42. April 12, 2024 Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
  43. Dexamethasone - paediatric investigation plan
  44. NMPA Issued the Announcement on Issues Pertaining to the Implementation of Drug Standards…
  45. Committee for Advanced Therapies (CAT): 17-18 July 2014
  46. PSUSA/00010584/201803 - periodic safety update report single assessment
  47. Regulations Governing Accreditation and Outsourced Accreditation Management of Cosmetic…
  48. ema-orlistat-referralOrlistat - referral
  49. EU/3/22/2606 - orphan designation for treatment of haemophilia A
  50. Submission of Clinical Trial Site Addition and change of Principal Investigator…
  51. 21 CFR 866.3480: Respiratory syncytial virus serological reagents.
  52. Joint European Medicines Agency/Parenteral Drug Association quality-by-design workshop
  53. Committee for Proprietary Medicinal Products (CPMP) 17th plenary meeting
  54. Public consultation opens on the revised guideline on the evaluation of human anticancer…
  55. Virtual live hands-on training course for Clinical Trials Sponsors using EudraVigilance…
  56. 21 CFR 26.81: Final provisions.
  57. Pravastatin sodium / Fenofibrate - paediatric investigation plan
  58. ema-riximyoRiximyo
  59. European Medicines Agency launches new website
  60. Clopidogrel Zentiva (previously Clopidogrel Winthrop)
  61. 21 CFR 20.116: Drug and device registration and listing information.
  62. First guidance on monoclonal antibodies for use in animals
  63. Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man…
  64. Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic…
  65. Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer…
  66. Cardiovascular Working Party
  67. EMEA-003156-PIP01-21 - paediatric investigation plan
  68. Drug Alert list for month of November 2019
  69. Transcatheter Mitral Valve Clip System Approved for Marketing
  70. CDSCO NSQ ALERT FOR THE MONTH OF June 2025
  71. 21 CFR 860.84: Classification procedures for “preamendments devices.”
  72. 21 CFR 861.20: Summary of standards development process.
  73. 21 CFR 880.5640: Lamb feeding nipple.
  74. Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers…
  75. cdsco-ritlecitinibRITLECITINIB
  76. ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug…
  77. 21 CFR 19.6: Code of ethics for government service.
  78. PSUSA/00001358/201803 - periodic safety update report single assessment
  79. cdsco-qge031-s-cQGE031 S.c
  80. Guideline on active substance master file procedure
  81. PSUSA/00000906/202305 - periodic safety update report single assessment
  82. EU/3/19/2146 - orphan designation for treatment of biliary tract cancer
  83. COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
  84. cdsco-canagloflozinCanagloflozin
  85. EU/3/15/1607 - orphan designation for treatment of acute radiation syndrome
  86. 21 CFR 884.4530: Obstetric-gynecologic specialized manual instrument.
  87. ema-ekesivyEkesivy
  88. Submission of referentials management services (RMS) and organisations management services…
  89. ema-sixmoSixmo
  90. 21 CFR 74.2707: D&C Yellow No. 7.
  91. Research and development (veterinary medicines)
  92. Guideline on Utilization of Master File for Drug Substances, etc. PFSB / ELD Notification…
  93. ema-melatonin-neurimMelatonin Neurim
  94. New strategy to fight antimicrobial resistance
  95. EMEA-003311-PIP01-22 - paediatric investigation plan
  96. Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence
  97. Firazyr - withdrawal of application for variation to marketing authorisation
  98. Submission deadlines for orphan designations
  99. ema-lumiracoxib-referralLumiracoxib - referral
  100. January 17 2017 GSR 42(E)
  101. Novel Therapies and Technologies Working Party
  102. DR_G.S.R. 930(E) dt_13.07.1978_Amendment in Sch V for Standards of patent or proprietary…
  103. Guidance on Evaluation of Accelerator Neutron Irradiation Device System for Boron Neutron…
  104. PSUSA/00001370/202204 - periodic safety update report single assessment
  105. 21 CFR 866.3205: Echovirus serological reagents.
  106. Committee for Advanced Therapies' activities streamlined
  107. EU/3/21/2524 - orphan designation for treatment of ovarian cancer
  108. 17th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
  109. ema-levitraLevitra
  110. Chapter 3 - Emissions Guidance Northern Ireland: Chapter 3 - Emissions Guidance - NI
  111. Renin-angiotensin-system (RAS)-acting agents - referral
  112. ema-bextraBextra
  113. Clinical investigation of medicinal products indicated for generalised anxiety disorder…
  114. Apply for a traditional herbal registration (THR)
  115. Strict regulatory actions to prevent illegal manufacturing, sale, distribution and import…
  116. ema-xagridXagrid
  117. European Medicines Agency recommends approval of a locally targeted treatment for…
  118. Veterinary medicinal products containing N-methyl pyrrolidone as an excipient - referral
  119. Meeting highlights from the Committee for Medicinal Products for Human Use,23-26 June 2008
  120. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 February 2025
  121. EU/3/20/2255 - orphan designation for treatment of myelofibrosis
  122. Regulatory flexibility to ensure availability of veterinary medicines during COVID-19…
  123. Zirconia Ceramic Femoral Head Approved for Marketing
  124. EMEA-003046-PIP01-21 - paediatric investigation plan
  125. 21 CFR 861.7: Contents of standards.
  126. EU/3/20/2260 - orphan designation for treatment in haematopoietic stem cell…
  127. PSUSA/00003162/201601 - periodic safety update report single assessment
  128. Update on investigation by Italian authorities into the supply of stolen medicines
  129. Arzoxifene - paediatric investigation plan
  130. Insulin Glargine Injection I.P., 100 IU/ml (BGL-GLAR)
  131. ReNew Biomedical Mints First CABT-Certified Apprentices
  132. EMEA-000499-PIP05-18 - paediatric investigation plan
  133. DR_G.S.R. 884(E) dt_11.12.2009_10A_10. Rimonabant
  134. Approved panel of experts for the Subject Expert Committees
  135. Matthew B. Weinger: The Path Forward for Satisfying User Interfaces in Health IT
  136. 21 CFR 866.2050: Staphylococcal typing bacteriophage.
  137. AAMI News, February 2021, Vol.56, No.2
  138. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - July 2017
  139. 21 CFR 886.1070: Anomaloscope.
  140. ema-duoresp-spiromaxDuoResp Spiromax
  141. ema-truscientTruScient
  142. ema-fluoxetin-nm-referralFluoxetin NM - referral
  143. Vandetanib product-specific bioequivalence guidance
  144. Committee for Orphan Medicinal Products (COMP): 18-20 May 2020
  145. EudraVigilance and signal management information day
  146. Guideline on the scientific application and the practical arrangements necessary to…
  147. cdsco-ambrisentanAmbrisentan
  148. EU/3/21/2463 - orphan designation for treatment of graft-versus-host disease
  149. EMA virtual technical media briefing on the RNA technology
  150. ema-kepivanceKepivance
  151. Pioglitazone IP + Vildagliptin (as sustained release form) Film coated bilayered tablet…
  152. EU/3/12/1083 - orphan designation for treatment chronic lymphocytic leukaemia
  153. EMEA-000055-PIP01-07-M06 - paediatric investigation plan
  154. EMEA-003108-PIP01-21 - paediatric investigation plan
  155. Reconstituting of Internal Complaint Committee on sexual Harassment cases regarding
  156. 21 CFR 870.4205: Cardiopulmonary bypass bubble detector.
  157. PSUSA/00001504/202004 - periodic safety update report single assessment
  158. EMEA-001547-PIP01-13 - paediatric investigation plan
  159. EMA reviewing medicines containing valsartan from Zhejiang Huahai following detection of…
  160. Fifth European Medicines Agency (EMA) and the Association of the European Self-Medication…
  161. Clinical Trials Information System (CTIS) sponsor end user training programme - April 2022
  162. Use of (fluoro)quinolones in food-producing animals in the European Union: development of…
  163. Committee for Advanced Therapies (CAT): 6-8 September 2023
  164. Etifoxine-containing medicinal products - referral
  165. Draft Guidelines for Evaluation of Nanopharmaceuticals in India
  166. Trelagliptin tablets 25mg/50mg/100mg
  167. 17th meeting of the Committee for Orphan Medicinal Products
  168. EMEA-001577-PIP02-14-M05 - paediatric investigation plan
  169. Registration open for orphan-product-designation and -grant workshop
  170. EU/3/17/1887 - orphan designation for treatment of congenital hyperinsulinism
  171. LUM-201 (Ibutamoren Mesylate)
  172. Theodore Cohen: The Importance of Software Security Updates for Medical Devices
  173. EU/3/13/1227 - orphan designation for treatment of adenovirus infection in allogeneic…
  174. ema-riquentRiquent
  175. cdsco-office-memorandumOffice Memorandum
  176. 21 CFR 26.4: Product coverage.
  177. Virtual ICUs Leverage Technology, Expertise for Critical Care
  178. Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 August 2013
  179. Cellular, Tissue, and Gene Therapies Advisory Committee July 30, 2026 Meeting…
  180. EU/3/16/1696 - orphan designation for treatment of post-transplantation…
  181. Biosimilar Medicinal Products Working Party
  182. Eric Abadie resigns as chair of the CHMP
  183. Lutetium (177Lu) chloride Billev (previously Illuzyce)
  184. EMEA annual report shows rise in applications for new medicines in 2004,with further…
  185. Medicines for use outside the European Union
  186. ema-yondelisYondelis
  187. European Medicines Agency receives 1,000th application for a Paediatric Investigation Plan…
  188. Tenacity in HTM: A Chat with Lee Chamberlain, 2022 BMET of the Year
  189. EMEA-000823-PIP02-10 - paediatric investigation plan
  190. Modified-released oral opioids - referral
  191. Committee for medicinal products for veterinary use: Meeting of 6-8 November 2007
  192. cdsco-ltdlnp3693LtdLNP3693
  193. ema-leqvioLeqvio
  194. ema-theralocTheraloc
  195. PSUSA/00000495/201801 - periodic safety update report single assessment
  196. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.6) Regulations…
  197. Clinical investigations: investigators' responsibilities
  198. Drug Alert list for month of November 2015
  199. November 3rd 2017 GSR 1369(E)
  200. 21 CFR 803.17: What are the requirements for developing, maintaining, and implementing…
  201. cdsco-transfer-policyTransfer Policy
  202. Executive Steering Group on Shortages of Medical Devices (MDSSG) meetings
  203. Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 February 2013
  204. SME Office wins award for 'Most significant contribution to mediscience sector'
  205. List of Drugs Medical Devices Vaccine and Cosmetics declared as Spurious for the Month of…
  206. ema-lyricaLyrica
  207. First COVID-19 vaccine approved for children aged 12 to 15 in EU
  208. Innovative Licensing and Access Pathway
  209. New treatment option for heavily pre-treated multiple myeloma patients
  210. Chamomillae romanae flos - herbal medicinal product
  211. EU/3/24/2904 - orphan designation for treatment of Lawrence syndrome
  212. EMEA-001817-PIP01-15 - paediatric investigation plan
  213. Quality of essential oils as active substances in herbal medicinal products/traditional…
  214. Team-NB PositionPaper-BPG-IVDR-V1-20230225
  215. Rules for Classification of Medical Devices
  216. Merck Sharp and Dohme Ltd. withdraws its marketing-authorisation application for Jenzyl…
  217. ema-diovan-referralDiovan - referral
  218. Guidance on the Implementation of the Ministerial Ordinance on the Good Laboratory…
  219. Approval process for Application received Online Sugam Portal with respect to Medical…
  220. Dexamethasone Sodium Phosphate
  221. Glycopyrroinum Bromide Ph. Eur + Fluticasone Furoate + Vilanterol Trifenatate inhalation…
  222. cdsco-leriglitazoneLeriglitazone
  223. 21 CFR 864.9650: Quality control kit for blood banking reagents.
  224. ema-atazanavir-krkaAtazanavir Krka
  225. 2011-2020: More than 40% decrease in sales of antimicrobials for use in animals
  226. Chapter 9 - General Advice on Due Diligence - Great Britain: Chapter 9 - General Advice on…
  227. Candesartan cilexetil - paediatric investigation plan
  228. Vyxeos liposomal (previously known as Vyxeos)
  229. Procedure to be followed for subsequent applicant in respect of FDCs declared as rational…
  230. European Medicines Agency confirms positive benefit-risk balance of Rotarix
  231. cdsco-isb-2001ISB 2001
  232. PSUSA/00002131/201903 - periodic safety update report single assessment
  233. Acotiamide ER tablet 300 tabletIII
  234. Committee for Herbal Medicinal Products (HMPC): 18-20 November 2024
  235. CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen
  236. Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063)
  237. Drug Safety Update: monthly PDF newsletter: November 2020 Drug Safety Update
  238. EU/3/12/1022 - orphan designation for treatment of familial partial lipodystrophy
  239. In Memoriam: John Masefield, a ‘Giant of Sterilization Technology’
  240. Committee for medicinal products for veterinary use: Meeting of 12 to 14 September 2006
  241. EU/3/16/1824 - orphan designation for treatment of perinatal asphyxia
  242. Conduct of bioequivalence studies for veterinary medicinal products - Scientific guideline
  243. Submit changes to labels and Patient Information Leaflets as a self-certification
  244. 2026.08.19 G.S.R 745(E)_Draft notification for inclusion of additional four drugs in…
  245. Guidance for PHMCA / HCSA Licensees and Telemedicine Service Providers: Advertisement…
  246. PSUSA/00001655/201802 - periodic safety update report single assessment
  247. Ursodeoxycholic acid product-specific bioequivalence guidance
  248. EU/3/24/2923 - orphan designation for treatment of small cell lung cancer
  249. ema-agopton-referralAgopton - referral
  250. Committee for Advanced Therapies (CAT): 11-13 June 2025
  251. In Memoriam: Larry R. Pilot, Innovation’s Wingman
  252. Better monitoring of biological medicines
  253. 21 CFR 862.1335: Glucagon test system.
  254. 21 CFR 73.250: Fruit juice.
  255. cdsco-clindamycinClindamycin
  256. EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental…
  257. EMEA-001155-PIP01-11-M03 - paediatric investigation plan
  258. EMEA-001146-PIP01-11-M07 - paediatric investigation plan
  259. ema-zostavaxZostavax
  260. Bismuth subcitrate potassium / Metronidazole / Tetracycline hydrochloride - paediatric…
  261. 21 CFR 880.6991: Medical washer.
  262. EMEA-002853-PIP01-20 - paediatric investigation plan
  263. Dr Tomas Salmonson elected new chair of the Committee for Medicinal Products for Human Use…
  264. EU/3/14/1417 - orphan designation for treatment of adult T-cell leukaemia/lymphoma
  265. Guidance on summary reports and issue-related analyses for medical devices
  266. 2016.01.25_S.O. 237(E)_Notification for Ablation device
  267. 21 CFR 14.90: Ad hoc advisory committee members.
  268. EMA business hours over Assumption Day, 15 August
  269. DR_G.S.R. 793(E) dt_13.12.1995_26A-reg FDC of Hydroxyquinoline group of drugs with any…
  270. Recommendation-NB-MED-2_5_5-Rec 5 Conformity Assessment of Own Brand Labelling
  271. Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 September…
  272. ema-pombilitiPombiliti
  273. European Medicines Agency marks 40th anniversary of PIC/S
  274. ema-mirvasoMirvaso
  275. 21 CFR 830.40: Use and discontinuation of a device identifier.
  276. Congress Programme ESDP 2006, Tenth Biannual Congress
  277. 2022.02.24_Final GSR 158_Inclusion of allura red colour in rule 127 of the Drugs Rules…
  278. Letermovir Tablets 240mg and 480mg
  279. EMEA-001447-PIP01-12 - paediatric investigation plan
  280. Regulations of Medical Device Tracking Management
  281. New add-on treatment for rare autoimmune inflammatory disorder
  282. EU/3/06/354 - orphan designation for treatment of primary hyperoxaluria
  283. Committee for Orphan Medicinal Products (COMP): 21-23 April 2020
  284. UK-wide licensing for human medicines
  285. PSUSA/00010145/201702 - periodic safety update report single assessment
  286. It's Sterilization Standards Week! What's It All About?
  287. EU/3/04/188 - orphan designation for treatment of moderate and severe traumatic brain…
  288. cdsco-pegfilgrastim-zrc-3128Pegfilgrastim (ZRC-3128)
  289. 21 CFR 876.1300: Ingestible telemetric gastrointestinal capsule imaging system.
  290. Responding to a GLP and GCP laboratory inspection report
  291. Quality aspects of pharmaceutical veterinary medicines for administration via drinking…
  292. 21 CFR 866.5500: Hypersensitivity pneumonitis immunological test system.
  293. November 30 2015 GSR 918(E)
  294. Liraglutide Sitagliptin
  295. EU/3/01/046 - orphan designation for treatment of graft-versus-host disease
  296. EMA regular press briefing on COVID-19
  297. Calcipotriol hydrate / hydrocortisone - paediatric investigation plan
  298. 21 CFR 1.361: What are the record availability requirements?
  299. Pharmacovigilance system: questions and answers
  300. PRAC recommends suspending marketing authorisations for infusion solutions containing…
  301. 21 CFR 56.107: IRB membership.
  302. Dronabinol - paediatric investigation plan
  303. cdsco-tapinarof-cream-1Tapinarof cream 1%
  304. EMEA-001806-PIP04-19-M01 - paediatric investigation plan
  305. Committee for Orphan Medicinal Products (COMP): 17-19 January 2023
  306. ema-cyclodextrinsCyclodextrins
  307. Polyether ether ketone (PEEK)
  308. 21 CFR 866.5520: Immunoglobulin G (Fab fragment specific) immunological test system.
  309. Have your say on EMA’s communications – how are we doing?
  310. Committee for Orphan Medicinal Products (COMP): 3-5 November 2020
  311. PSUSA/00001869/202006 - periodic safety update report single assessment
  312. cdsco-drugs-rules-1945Drugs Rules 1945
  313. ema-simparica-trioSimparica Trio
  314. Clinical Trial Applications (Phase I, Il and III) for Cell and Gene Therapeutics Products…
  315. cdsco-lasmiditan-migrainelasmiditan (Migraine)
  316. Eye injuries in people and dogs when using Osurnia ear gel for dogs
  317. EU/3/16/1734 - orphan designation for treatment of McArdle's disease
  318. Inactivated poliomyelitis vaccine 12March
  319. FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and…
  320. EMA recommends approval of second adapted Spikevax vaccine
  321. EU/3/22/2576 - orphan designation for treatment of pancreatic cancer
  322. Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP +…
  323. September 7-8, 2023: Microbiology Devices Panel of the Medical Devices Advisory Committee…
  324. ema-download-medicine-dataDownload medicine data
  325. 21 CFR 821.50: Availability.
  326. Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
  327. ema-imatinib-teva-b-vImatinib Teva B.V.
  328. cfr-21-cfr-82-3-definitions21 CFR 82.3: Definitions.
  329. Committee for Medicinal Products for Human Use (CHMP): 18-21 February 2013
  330. 21 CFR 868.5965: Positive end expiratory pressure breathing attachment.
  331. Tafenoquine 50mg and 150 mg Tablets
  332. PSUSA/00003086/201812 - periodic safety update report single assessment
  333. PSUSA/00001832/202104 - periodic safety update report single assessment
  334. Data submission on authorised medicines (Article 57)
  335. EMEA-002816-PIP01-20 - paediatric investigation plan
  336. European Medicines Agency starts review of Tredaptive, Pelzont and Trevaclyn
  337. Committee on Herbal Medicinal Products elects new chair and vice-chair
  338. PIC Convention of 1970
  339. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 March 2013
  340. 21 CFR 886.1190: Distometer.
  341. 21 CFR 25.42: Environmental impact statements.
  342. cdsco-miricorilantMiricorilant
  343. PSUSA/00000022/202003 - periodic safety update report single assessment
  344. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Linagliptin film coated…
  345. PSUSA/00001075/201504 - periodic safety update report single assessment
  346. Pholcodine-containing medicinal products - referral
  347. ema-xegafriXegafri
  348. EMEA-000954-PIP01-10 - paediatric investigation plan
  349. EMEA-001831-PIP01-15 - paediatric investigation plan
  350. Public statement: Baraclude (entecavir): Occurrence of a resistant HIV variant in a…
  351. Paediatric requirements for marketing-authorisation applications
  352. EMA takes yet another step in public engagement with its first public hearing
  353. EU/3/07/478 - orphan designation for treatment of Hodgkin's lymphoma
  354. 21 CFR 12.62: Commencement of functions.
  355. ema-e-reportinge-Reporting
  356. ema-kexxtoneKexxtone
  357. COVID-19: information on veterinary medicines
  358. Guide to Notified Bodies Designation Process
  359. Medicine evaluation figures: archive 2010-2015
  360. European Medicines Agency's Management Board endorses revised policy on handling of…
  361. ema-ronapreveRonapreve
  362. Clinical Trials Information System (CTIS) bitesize talk: Deferral rules and Public website
  363. cdsco-oms721OMS721
  364. Recommendations to restrict use of fosfomycin antibiotics
  365. Committee for veterinary medicinal products: 45th meeting
  366. Guideline on adjuvants in vaccines for human use
  367. Pirfenidone product-specific bioequivalence guidance
  368. ema-jardianceJardiance
  369. Evaluation of bovine spongiform encephalopathies (BSE)-risk via the use of materials of…
  370. First malaria vaccine receives positive scientific opinion from EMA
  371. 2022.05.18_Final GSR 357(E)_Inclusion of Acitretin in Sch H of Drugs Rules 1945
  372. EMEA-000886-PIP01-10 - paediatric investigation plan
  373. Ceftriaxone Tyrol Pharma - referral
  374. Non-pharmacopoeial reference standards for herbal substances, herbal preparations and…
  375. PSUSA/00000477/202203 - periodic safety update report single assessment
  376. EMEA-000884-PIP01-10 - paediatric investigation plan
  377. LinkedIn Live interview with Ivo Claassen: Tomorrow's veterinary medicines for healthy…
  378. 4 innovative products including implantable deep brain stimulation electrode lead kit…
  379. EU/3/12/962 - orphan designation for treatment of multiple myeloma
  380. PSUSA/00002082/201706 - periodic safety update report single assessment
  381. EU/3/07/497 - orphan designation for treatment of hepatocellular carcinoma
  382. Co-development of pharmacogenomic biomarkers and assays in the context of drug development…
  383. Immunologicals Working Party
  384. cfr-21-cfr-812-3-definitions21 CFR 812.3: Definitions.
  385. ema-revestiveRevestive
  386. Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for…
  387. Perlinring and associated names - referral
  388. Herbal medicines 2004 – 2014
  389. Juniperi galbulus (pseudo-fructus) - herbal medicinal product
  390. PSUSA/00010806/202110 - periodic safety update report single assessment
  391. PSUSA/00001986/202001 - periodic safety update report single assessment
  392. COVID-19 vaccines approved in the country as on 22.04.2026
  393. 21 CFR 1.232: What information is required in the registration?
  394. EMEA-000064-PIP01-07 - paediatric investigation plan
  395. ema-arexvyArexvy
  396. EU/3/07/482 - orphan designation for treatment of hepatocellular carcinoma
  397. ema-alymsysAlymsys
  398. Bringing National Perspective to International Standards: A Conversation with Scott…
  399. ema-valtrex-referralValtrex - referral
  400. Asimily Leader Recognized With 2022 AAMI Award
  401. cdsco-remdesivir100-mgRemdesivir100 mg
  402. Guidelines for the evaluation of sterilants and disinfectants
  403. PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan…
  404. NMPA Announcement on Two Guidelines for Registration Review of Drug-Device Combination…
  405. ema-dengvaxiaDengvaxia
  406. Cefepime-Tazobactam vs. Meropenem
  407. AU P0036 Remote Auditing Pilot Program
  408. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 March 2017
  409. Renaming of Central Drugs Standard Control Organization dated 06.09.2018
  410. 21 CFR 15.20: Notice of a public hearing before the Commissioner.
  411. European Medicines Agency announces next steps for the maintenance of information on…
  412. Suvaxyn PRRS MLV - opinion on variation to marketing authorisation
  413. Guidance Document - Management of Application for Medical Device Licenses
  414. Recruitment Rule of Drugs Inspector in CDSCO
  415. ema-briumviBriumvi
  416. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  417. cdsco-selinexorSelinexor
  418. Workshop: In vitro cytokine-release assays
  419. ema-datscanDaTSCAN
  420. Public Statement on Leflunomide (Arava) - Pancytopenia and Serious Skin Reactions
  421. 21 CFR 862.1575: Phospholipid test system.
  422. ema-primavaxPrimavax
  423. Scandonest and associated names - referral
  424. World Standards Week: Looking at the Impact of an AAMI Standard
  425. ema-palynziqPalynziq
  426. ema-udenycaUdenyca
  427. Molnupiravir Moderateh2
  428. European Medicines Agency recommends suspension of marketing authorisations for oral…
  429. EU/3/15/1467 - orphan designation for treatment of epidermolysis bullosa
  430. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19…
  431. Committee for Medicinal Products for Human Use (CHMP): 22-25 February 2021
  432. 21 CFR 17.51: Judicial review.
  433. Provisions for Medical Device Registration (Abolished)
  434. cdsco-afliberceptAflibercept
  435. Letairis - Liver injury warning to be removed from Letairis (ambrisentan) tablets
  436. Notice-dated 13.12.2012: DRUG ALERT
  437. Favipiravir Tablet 200/800 m
  438. EMEA-001214-PIP02-17 - paediatric investigation plan
  439. Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master…
  440. PSUSA/00001813/201410 - periodic safety update report single assessment
  441. ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific…
  442. Medical Device Regulation comes into application
  443. 21 CFR 868.1750: Pressure plethysmograph.
  444. PSUSA/00002316/202208 - periodic safety update report single assessment
  445. Metamizole-containing medicinal products - referral
  446. EMEA-002563-PIP02-19-M02 - paediatric investigation plan
  447. Dexamed and associated names - referral
  448. ema-lederfoline-referralLederfoline - referral
  449. Clinical investigation of medicinal products indicated for panic disorder - Scientific…
  450. GlaxoSmithKline withdraws its marketing authorisation application for Bosatria…
  451. Asked & Answered: June 2020
  452. 21 CFR 872.3560: OTC denture reliner.
  453. Carmustine medac (previously Carmustine Obvius)
  454. PSUSA/00000905/202307 - periodic safety update report single assessment
  455. EudraVigilance signal detection methods help detect drug safety issues earlier
  456. EU/3/20/2301 - orphan designation for treatment of acute respiratory distress syndrome…
  457. EU/3/19/2238 - orphan designation for treatment of mucopolysaccharidosis type IVA (Morquio…
  458. CHMP meeting on 8 September 2010 to discuss Avandia and Pandemrix
  459. Management Board meeting: 14-15 June 2017
  460. Health Canada and FDA eSTAR pilot: Notice to industry
  461. FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from…
  462. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 January 2020
  463. Steam Generation in Canneries
  464. Barrett Franklin: I Love Technology, but It Isn’t Always the Answer
  465. EMEA-002718-PIP02-20 - paediatric investigation plan
  466. ema-idelvionIdelvion
  467. EMA webinar for fact checkers: Safety of COVID-19 vaccines and therapeutics
  468. EMEA-002648-PIP01-19 - paediatric investigation plan
  469. Tranexamic Acid Spray 10% w/v Acid Spray 10% w/v Acid Spray 10% w/v
  470. EMA to provide guidance on avoiding nitrosamines in human medicines
  471. PSUSA/00001307/202007 - periodic safety update report single assessment
  472. Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA)…
  473. EU/3/14/1415 - orphan designation for treatment of placental insufficiency
  474. Scenesse - withdrawal of application for variation to marketing authorisation
  475. EMA Management Board: highlights of June 2024 meeting
  476. Second stakeholder meeting on the implementation of the European Medicines Agency's policy…
  477. European Shortages Monitoring Platform Essentials and Industry Reporting Requirements
  478. Maximum residue limit opinions
  479. EU/3/18/2057 - orphan designation for treatment of acute myeloid leukaemia
  480. EMEA-001138-PIP02-11 - paediatric investigation plan
  481. New advanced therapy to repair cartilage defects in the knee
  482. FDA evaluating the potential risks of using codeine cough-and-cold medicines in children
  483. Review of flupirtine-containing medicines started
  484. EMA fast-tracks antidote to anticoagulant Pradaxa
  485. 21 CFR 888.3210: Finger joint metal/metal constrained cemented prosthesis.
  486. EMA gets ready for relocation decision
  487. Clinical investigation of immunosuppressants for solid organ transplantation - Scientific…
  488. 21 CFR 74.1602: D&C Violet No. 2.
  489. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  490. PSUSA/00002843/202104 - periodic safety update report single assessment
  491. Erythropoietin 4000 IU Pre-filled syringe for intravenous injection
  492. Abatacept 125 mg/mL solution for injection in autoinjector or prefilled syringe
  493. 21 CFR 878.4961: Mountable electromechanical surgical system for transluminal approaches.
  494. European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines
  495. Dydrogesterone Sustained Release Tablet 30 mg
  496. ema-kalbitorKalbitor
  497. ema-axitinib-accordAxitinib Accord
  498. EMEA-000117-PIP01-07-M07 - paediatric investigation plan
  499. EMEA-002617-PIP02-19 - paediatric investigation plan
  500. Paediatric strategy forum for medicinal product development for acute myeloid leukaemia in…
  501. ema-adlumizAdlumiz
  502. EU/3/18/2068 - orphan designation for treatment of growth hormone deficiency
  503. Re-tendering for Housekeeping and General cleanliness in the CDSCO(HQ), FDA Bhawan, Kotla…
  504. cdsco-belantamab-mafodotinBelantamab Mafodotin
  505. Second joint Drug Information Association/European Medicines Agency statistics workshop
  506. ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
  507. Brexit regulatory preparedness for veterinary medicinal products in the centralised…
  508. Mirabegron (as extended release form) + Silodosin tablets (Phase III)
  509. cdsco-mercury-limit-gsr56-eMercury Limit-GSR56(E)
  510. Ezetimibe product-specific bioequivalence guidance
  511. EU/3/21/2538 - orphan designation for treatment of pulmonary arterial hypertension
  512. PSUSA/00001320/201709 - periodic safety update report single assessment
  513. Romiplostim (r-DNA) powder for solution for Injection250μg/0.5ml
  514. EU/3/19/2197 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  515. Occupied wheelchairs in cars and private transport - reminders of safe use
  516. Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to…
  517. EMEA-002542-PIP01-18 - paediatric investigation plan
  518. Acotiamide Sustained 300 mg Tablet 300 mg t
  519. EMA receives application for conditional marketing authorisation of Novavax’s COVID-19…
  520. ema-innovax-ilt-ibdInnovax-ILT-IBD
  521. IT systems temporarily unavailable from 18 to 20 June 2021
  522. EU/3/13/1187 - orphan designation for treatment of splenic marginal-zone lymphoma
  523. NMPA Announcement on Issuing the Rules for Registration and Notification Dossiers of…
  524. Webinar presentation: Inspection reliance
  525. Utilization of Sample Informed Consent Form and Assent Form in Pediatric Clinical Trials…
  526. 2015.09.02_S.O. 2393(E)_Notification for Government Analyst
  527. Medicines: apply for a parallel import licence
  528. Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma
  529. 21 CFR 890.3610: Rigid pneumatic structure orthosis.
  530. ema-ratioepoRatioepo
  531. EU/3/09/703 - orphan designation for treatment of pancreatic cancer
  532. Risperdal Consta - referral
  533. EMEA-002378-PIP01-18 - paediatric investigation plan
  534. 21 CFR 12.28: Denial of hearing in whole or in part.
  535. PSUSA/00010569/201812 - periodic safety update report single assessment
  536. Committee for Medicinal Products for Veterinary Use (CVMP):11-13 June 2013
  537. Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 November 2025
  538. ema-plenadrenPlenadren
  539. Data requirements for applications for immunological veterinary medicinal products…
  540. Supply unlicensed medicinal products (specials)
  541. DARWIN EU Advisory Board meeting: 20 September 2021
  542. Medicinal products for the treatment of insomnia - Scientific guideline
  543. ema-pylori-chekPylori-Chek
  544. Notice - dated 17.01.2013: Admn
  545. Paediatric Committee (PDCO): 21-24 March 2017
  546. Revised timelines for certificates of pharmaceutical products (CPPs) and temporary…
  547. 21 CFR 80.32: Limitations of certificates.
  548. Surveying the Field: KiiP Team Gains Deeper Insight into Sterile Packaging and Its Use
  549. Caprelsa - direct healthcare professional communication (DHPC)
  550. European Medicines Agency advises on compassionate use of sofosbuvir
  551. ema-neoleishNeoleish
  552. ema-masiproMasipro
  553. Baricitinib in Patients
  554. EU/3/04/220 - orphan designation for treatment of glioma
  555. EU/3/22/2668 - orphan designation for treatment of pachyonychia congenita
  556. European Medicines Agency closed 9 May 2012
  557. Committee for Advanced Therapies (CAT): 8-10 September 2021
  558. cdsco-filgotinib-crohnFilgotinib Crohn
  559. ema-ixempraIxempra
  560. PSUSA/00003159/201612 - periodic safety update report single assessment
  561. PSUSA/00010710/201901 - periodic safety update report single assessment
  562. cfr-21-cfr-12-1-scope21 CFR 12.1: Scope.
  563. Virus validation studies: the design, contribution and interpretation of studies…
  564. EMEA-000024-PIP01-07 - paediatric investigation plan
  565. EMEA-002479-PIP01-18-M01 - paediatric investigation plan
  566. Provisions for Instructions and Labels of Medical Devices (Decree No.6 of China Food and…
  567. 21 CFR 862.1245: Dehydroepiandrosterone (free and sulfate) test system.
  568. 2025.08.27_G.S.R. 587(E)_Draft Notification for application of unapproved drugs for…
  569. 21 CFR 1.625: What records requirements must an accreditation body that has been…
  570. EMEA-000639-PIP06-20 - paediatric investigation plan
  571. PSUSA/00001231/201710 - periodic safety update report single assessment
  572. GN-05-R2.1 Guidance on the Reporting of Adverse Events(2022 Nov)_PUB
  573. Paracetamol Injection 500mg/2ml for IM route Phase III
  574. Pantoprazole Sodium IP Aspirin IP Capsules
  575. Standard for PPE Updated for Additional Equipment Types and Safety Guidance
  576. Big Data strategy for veterinary medicines in the EU
  577. EU/3/22/2648 - orphan designation for treatment of malignant mesothelioma
  578. EMEA-000876-PIP01-10-M01 - paediatric investigation plan
  579. World Health Day 2014: focus on diseases transmitted by vectors
  580. Documentary Requirements for Class 1 CTGTP Notification and Updates
  581. FAQ on Medical Device Rule,2017
  582. UPDATED PUBLIC PARTICIPATION INFORMATION: October 13, 2017: Meeting of the Dermatologic…
  583. PSUSA/00010376/201804 - periodic safety update report single assessment
  584. PSUSA/00010441/202304 - periodic safety update report single assessment
  585. EU/3/06/370 - orphan designation for treatment of acute myeloid leukaemia
  586. Elranatamab (PF-06863135
  587. EMEA-001664-PIP02-15-M05 - paediatric investigation plan
  588. 21 CFR 892.1830: Radiologic patient cradle.
  589. Request to cancel an ARTG entry
  590. PSUSA/00002322/202008 - periodic safety update report single assessment
  591. EU/3/15/1586 - orphan designation for treatment of neurotrophic keratitis
  592. AZD0780 30mg Tablet or Placebo
  593. EMEA-003241-PIP01-22 - paediatric investigation plan
  594. 21 CFR 810.18: Public notice.
  595. EU/3/22/2730 - orphan designation for treatment of peripheral T-cell lymphoma
  596. ema-amoxil-referralAmoxil - referral
  597. Steve Baker: The FDA's Glacial Pace
  598. EMEA-002840-PIP01-20 - paediatric investigation plan
  599. Enforcement of the Drug Sample Distribution Requirements of the Prescription Drug…
  600. cdsco-molnupiravir-mildaplMolnupiravir Mildapl
  601. 21 CFR 892.5700: Remote controlled radionuclide applicator system.
  602. FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines…
  603. SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD)
  604. Product-information templates - Human
  605. 21 CFR 73.3124: Phthalocyanine green.
  606. ema-tegsediTegsedi
  607. Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic…
  608. EU/3/13/1174 - orphan designation for treatment of acute myeloid leukaemia
  609. Preventive Controls and Sanitary Human Food Operations
  610. cdsco-byl719BYL719
  611. cfr-21-cfr-874-4770-otoscope21 CFR 874.4770: Otoscope.
  612. EMEA-001574-PIP01-13 - paediatric investigation plan
  613. cdsco-crisaborole-ointment-2Crisaborole Ointment 2%
  614. 2012.05.31_S.O. 1261(E)_Dr. Gyanendra Nath Singh, Sec. Cum Scietificd Directior,_ As LA…
  615. EMEA-000520-PIP02-13-M04 - paediatric investigation plan
  616. NMPA Issued the Notice on the Implementation Plan of the State Council for Full-Coverage…
  617. IT systems unavailable from 18 to 20 September 2020
  618. International cooperation to align approaches for regulation of COVID-19 vaccines and…
  619. PSUSA/00000022/201703 - periodic safety update report single assessment
  620. 2017 Pharmacovigilance Inspectors Working Group training course
  621. 1st EMEA workshop with health professionals and academia on orphan medicinal products
  622. 2020.10.21_Draft GSR 656(E)_Inclusion of Tapentadol in Sch H1.pdf
  623. EMEA-001073-PIP02-14 - paediatric investigation plan
  624. Master File System for Drug Substances, etc.
  625. PSUSA/00010651/202105 - periodic safety update report single assessment
  626. EMEA-001712-PIP02-15 - paediatric investigation plan
  627. Procedure for Remote Inspection as a part of compliance inspection on drugs and…
  628. GN-03-R3 Guidance on Preparation of a Site Master File for Licensing
  629. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 September 2011
  630. PSUSA/00001312/201708 - periodic safety update report single assessment
  631. Process validation for listed and complementary medicines
  632. COVID-19: latest updates (archive)
  633. Ranibizumab Solution for Injection10 mg/ml, 0.23ml vial
  634. ACTD Clinical Check List for Product Classification
  635. DR_G.S.R. 49(E) dt_31.01.1984_26A_Prohibition of manufacture of Methaqualone
  636. Drug Alert list for month of January 2017
  637. Aliskiren product-specific bioequivalence guidance
  638. Advanced therapies: marketing authorisation
  639. 21 CFR 872.1745: Laser fluorescence caries detection device.
  640. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical…
  641. 21 CFR 1.1395: Under what circumstances may FDA revise or revoke modified requirements or…
  642. EU/3/14/1360 - orphan designation for treatment of haemophilia A
  643. Combikit Each Strip contains: 1 Tablet of Part A: Dapagliflozin Tablet 10/10/10/10mg 1…
  644. 21 CFR 892.1170: Bone densitometer.
  645. Communication@EMA – how are we doing?
  646. cdsco-rotavirus-vaccineRotavirus Vaccine
  647. 21 CFR 870.5310: Automated external defibrillator system.
  648. Aesthetic-Related Guidelines_2018
  649. Cardiologist Considers Healthcare Implications of iPhone
  650. European Medicines Agency (EMA)/European Generic medicines Association joint workshop on…
  651. Nothing About Artificial Intelligence is 'Wait and See' at HIMSS23
  652. Announcement of the National Medical Products Administration, the Ministry of Public…
  653. Guide to Fees for Human Products
  654. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 June 2025
  655. ema-revlimidRevlimid
  656. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  657. ema-istodaxIstodax
  658. FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used…
  659. EMEA-000599-PIP01-09-M07 - paediatric investigation plan
  660. EU scientific opinion: how to assess progress on reduction of antimicrobial resistance and…
  661. ICH guideline Q13 on continuous manufacturing of drug substances and drug products…
  662. Core summary of product characteristics for human plasma-derived and recombinant…
  663. Looking Back While Moving Forward: Implementing BMET Apprenticeships
  664. ACMD meeting statement, Meeting 51, 29 November 2019
  665. ema-novorapidNovoRapid
  666. PSUSA/00000928/201412 - periodic safety update report single assessment
  667. DARWIN EU® continues expanding its capacity to deliver real-world data studies
  668. GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the…
  669. Meet the AAMI & GE Healthcare BMET of the Year: Christopher Stringer
  670. EU/3/22/2720 - orphan designation for treatment of adrenoleukodystrophy
  671. 21 CFR 1.381: May a detained article of food be delivered to another entity or transferred…
  672. EU/3/22/2649 - orphan designation for treatment of follicular lymphoma
  673. NMPA Issued Four Guidelines for Technical Review of the Registration of Assay Reagents for…
  674. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23…
  675. 21 CFR 868.5590: Scavenging mask.
  676. EMA starts second rolling review of a COVID-19 vaccine
  677. eXtended EudraVigilance medicinal product dictionary face-to-face training course
  678. EU/3/08/529 - orphan designation for treatment of visceral leishmaniasis
  679. FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair…
  680. ema-vemlidyVemlidy
  681. PSUSA/00003005/201503 - periodic safety update report single assessment
  682. Paediatric Committee (PDCO): 20-23 April 2021
  683. EMEA-002794-PIP01-20 - paediatric investigation plan
  684. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 April 2017
  685. 21 CFR 870.3720: Pacemaker electrode function tester.
  686. EU/3/06/419 - orphan designation for treatment of pancreatic cancer
  687. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
  688. 21 CFR 807.85: Exemption from premarket notification.
  689. Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 March 2019
  690. Management Board meeting: 17 June 2021
  691. Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum…
  692. cdsco-regorafenibRegorafenib
  693. EU/3/18/2014 - orphan designation for treatment of Stargardt's disease
  694. EMEA-001796-PIP03-16-M03 - paediatric investigation plan
  695. Guidance for the use of medicinal cannabis in the treatment of epilepsy in paediatric and…
  696. Compliance of authorised equine influenza vaccines with OIE requirements - Scientific…
  697. EMEA-001057-PIP01-10-M01 - paediatric investigation plan
  698. Order regarding Luxury Lifestyle on 17.06.2019
  699. ema-panacur-aquasolPanacur AquaSol
  700. Stakeholder meetings: pharmacovigilance legislation
  701. EU/3/06/379 - orphan designation for treatment of alopecia totalis
  702. April 6, 2021: Circulatory System Devices Panel of the Medical Devices Advisory Committee…
  703. cdsco-omalizumabOmalizumab
  704. EU/3/23/2823 - orphan designation for treatment of Pelizaeus-Merzbacher disease
  705. cfr-21-cfr-814-1-scope21 CFR 814.1: Scope.
  706. 5-ARIs - 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious…
  707. FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among…
  708. EMEA-002242-PIP02-21 - paediatric investigation plan
  709. cdsco-vib4920VIB4920
  710. 21 CFR 866.2190: Automated image assessment system for microbial colonies on solid culture…
  711. cdsco-tislelizumaTislelizuma
  712. NMPA Announcement on Issuing 6 Guidance including the Guidance for Nomenclature of the…
  713. Committee for Advanced Therapies (CAT) elects chair and vice-chair
  714. European Medicines Agency sets out next steps on access to clinical-trial data
  715. New Consensus on the Sterilization of Single-Use Systems for Manufacturing
  716. EMEA-001865-PIP02-16 - paediatric investigation plan
  717. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 September 2025
  718. Salim Kai: A Vision for HTM Leadership
  719. 21 CFR 1.1107: When must food testing be conducted under this subpart?
  720. Ongoing stability testing for listed and complementary medicines
  721. PSUSA/00001858/201909 - periodic safety update report single assessment
  722. 21 CFR 886.1650: Ophthalmic bar prism.
  723. PSUSA/00010289/201508 - periodic safety update report single assessment
  724. 21 CFR 864.7455: Fetal hemoglobin assay.
  725. Information meeting on participation of Croatia and Turkey in EMEA activities in 2006 and…
  726. PSUSA/00001348/201605 - periodic safety update report single assessment
  727. PSUSA/00010767/202310 - periodic safety update report single assessment
  728. EMEA-000809-PIP01-09-M01 - paediatric investigation plan
  729. Application form for Compensation-DePuy_Johnson
  730. ema-keppraKeppra
  731. 21 CFR 868.1900: Diagnostic pulmonary-function interpretation calculator.
  732. 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener.
  733. cdsco-hrf-10071-120-mgHRF-10071 -120 mg
  734. ema-ozempicOzempic
  735. Oleae folium - herbal medicinal product
  736. Training session for patients and consumers involved in European Medicines Agency (EMA)…
  737. DR_G.S.R. 390(E) dt_24.04.2018_Prohibit the import of Oxytocin under Section 10A
  738. cdsco-noticeNotice
  739. Plasma Derived Human coagulation factor VIII Product
  740. EU/3/06/381 - orphan designation for treatment of pneumonia caused by serotype O11…
  741. VICH GL52 Bioequivalence: blood level bioequivalence study - Scientific guideline
  742. NMPA Notice on Issuing the Requirements for Change Items of Marketed Traditional Chinese…
  743. 21 CFR 880.2460: Electrically powered spinal fluid pressure monitor.
  744. EU/3/11/856 - orphan designation for treatment of mitochondrial neurogastrointestinal…
  745. ICH E2F Development safety update report - Scientific guideline
  746. ema-zytigaZytiga
  747. PSUSA/00001071/201504 - periodic safety update report single assessment
  748. European Medicines Agency / Committee for Medicinal Products for Human Use Working Group…
  749. GN-15-R12 Guidance on Medical Device Product Registration (2025 Aug) PUB
  750. Ten years of the Orphan Regulation in Europe
  751. Medical devices: UK approved bodies
  752. P/117/2010 - paediatric investigation plan
  753. Siponimod Tablets 0.25 mg, 1mg and 2mg
  754. 21 CFR 870.4150: Extracorporeal system for carbon dioxide removal.
  755. Committee for Orphan Medicinal Products (COMP): 17-19 May 2016
  756. Supplying investigational medicinal products to Northern Ireland
  757. Health Ministry approves compensation formula for Hip implant cases
  758. PSUSA/00000742/201808 - periodic safety update report single assessment
  759. Regulatory update - EMA encourages companies to submit type I variations for 2020 by end…
  760. 2022.02.09_S.O. 553(E)_ Stockpiling of new drug under phase 3 of clinical trial_NDCTR 2019
  761. ema-corluxinCorluxin
  762. Improving safety of first-in-human clinical trials
  763. EMEA-001854-PIP01-15 - paediatric investigation plan
  764. P/13/2010 - paediatric investigation plan
  765. European Medicines Agency recommends restricting use of tolperisone medicines
  766. Ulinastatin for Injection
  767. PSUSA/00002156/202008 - periodic safety update report single assessment
  768. EU/3/14/1347 - orphan designation for treatment of pyridoxamine 5'-phosphate oxidase…
  769. DR_G.S.R. 270(E) dt_30.03.2012_Corregendum to GSR 733(E) dt 29.09.2011
  770. Changes in the Human Medicines Evaluation Unit and nomination of new Head of Unit
  771. ema-daklinzaDaklinza
  772. Paediatric Committee (PDCO): 7-9 August 2013
  773. Pregabalin IP (as prolonged release form) + Mecobalamin IP + Nortriptyline HCl film coated…
  774. ema-esignature-webinareSignature webinar
  775. EU/3/06/353 - orphan designation for treatment of renal-cell carcinoma
  776. PSUSA/00003047/201412 - periodic safety update report single assessment
  777. EMEA-001811-PIP03-20 - paediatric investigation plan
  778. PSUSA/00010444/202309 - periodic safety update report single assessment
  779. VICH GL20 Efficacy of anthelmintics: specific recommendations for felines - Scientific…
  780. Committee for veterinary medicinal products: Meeting of 8 to 9 April 2003
  781. 21 CFR 73.3126: Titanium dioxide.
  782. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May…
  783. EU/3/13/1129 - orphan designation for treatment of graft-versus-host disease
  784. Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor…
  785. EU/3/02/109 - orphan designation for treatment of ovarian cancer
  786. EU/3/05/337 - orphan designation for treatment of cystic fibrosis
  787. EMEA-001527-PIP01-13 - paediatric investigation plan
  788. 21 CFR 874.4180: Eustachian tube balloon dilation system.
  789. Implantable Sacral Nerve Stimulation System Approved for Marketing
  790. NOTICE regading List of Private drugs testing approved in form 37 of schedule A of drugs…
  791. Committees, working parties and other groups
  792. PSUSA/00001124/202311 - periodic safety update report single assessment
  793. ema-vaxchoraVaxchora
  794. Pneumococcal (Polysaccharide Conjugate Vaccine (15-Valent)
  795. NMPA issued the Announcement on Matters Concerning the Production of Imported Medical…
  796. ema-bB
  797. Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
  798. 21 CFR 890.1575: Force-measuring platform.
  799. EU/3/18/2043 - orphan designation for treatment of glioma
  800. EU/3/22/2586 - orphan designation for treatment of fragile X syndrome
  801. EMEA-003170-PIP01-21-M01 - paediatric investigation plan
  802. Doxycycline hyclate - referral
  803. European Medicines Agency starts infringement procedure to investigate Roche's alleged…
  804. Amorphous Hydrogel with Colloidal Silver
  805. PSUSA/00010021/201507 - periodic safety update report single assessment
  806. cdsco-ozenoxacinOzenoxacin
  807. Committee for Advanced Therapies (CAT): 15-16 January 2015
  808. cdsco-avelumabAvelumab
  809. 21 CFR 862.3950: Vancomycin test system.
  810. Provisions for the Lot Release of Biological Products (CFDA Decree No.39) (Abolished)
  811. PSUSA/00010748/201907 - periodic safety update report single assessment
  812. VICH GL50 Harmonisation of criteria to waive target animal batch safety testing for…
  813. Hydrocorticosone Acetate
  814. European Medicines Agency recommends new advice to surgeons on safer use of fibrin…
  815. ema-sevofloSevoFlo
  816. EMEA-001886-PIP02-15-M01 - paediatric investigation plan
  817. cdsco-scy-078SCY 078
  818. 21 CFR 20.84: Disclosure to consultants, advisory committees, State and local government…
  819. Clinical trials for medicines: Notification of Serious Breaches of GCP or the trial…
  820. cdsco-azacitidine-100-mgAzacitidine 100 mg
  821. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 September 2018
  822. QMS P0011.005: Complaints and/or Customer Feedback Procedure
  823. 21 CFR 868.5570: Nonrebreathing mask.
  824. 21 CFR 810.13: Mandatory recall order.
  825. Information day on medication errors
  826. Proton Pump Inhibitors - Clostridum difficile -associated diarrhea can be associated with…
  827. Joint European Medicines Agency/Drug Information Association information day on…
  828. ema-shotaflor-referralShotaflor - referral
  829. 21 CFR 876.5270: Implanted electrical urinary continence device.
  830. Pegylated interferon alfa-2b
  831. Minocycline Hydrochloride Topical Gel 4%
  832. Drug Safety Update: monthly PDF newsletter: Drug Safety Update February 2023
  833. EMEA-002269-PIP01-17-M01 - paediatric investigation plan
  834. EMEA-000929-PIP01-10 - paediatric investigation plan
  835. EU/3/15/1476 - orphan designation for treatment of tularaemia
  836. MEMBER EXCLUSIVE: Frontiers in Cybersecurity Roundtable
  837. European Medicines Agency recommends suspension of marketing authorisation for sibutramine
  838. Committee for Orphan Medicinal Products (COMP): 16-18 July 2019
  839. Regulation for Designation of Medical Device Clinical Trial Institute
  840. Drug Alert list for month of April 2022
  841. EU/3/24/2937 - orphan designation for treatment of acute myeloid leukaemia
  842. 21 CFR 73.1350: Mica-based pearlescent pigments.
  843. 21 CFR 864.3260: OTC test sample collection systems for drugs of abuse testing.
  844. 21 CFR 866.2850: Automated zone reader.
  845. European Medicines Agency makes first recommendation for use of a medicine in children…
  846. EU/3/14/1261 - orphan designation for prevention of bronchopulmonary dysplasia
  847. ema-duloxetine-sandozDuloxetine Sandoz
  848. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - October 2018
  849. EU/3/13/1208 - orphan designation for treatment of Stargardt's disease
  850. ema-incurinIncurin
  851. MDR_G.S.R. 754(E) dt_30.09.2022_Regulation of sale of medical devices via registration of…
  852. EMEA-002835-PIP01-20 - paediatric investigation plan
  853. EU/3/04/193 - orphan designation for treatment of ovarian cancer
  854. ema-nplateNplate
  855. FEEDBACK FORM to CDSCO (HQ) on the performance of PRO to improve the quality of services
  856. Supply shortages of Cerezyme and Fabrazyme - priority access for patients most in need of…
  857. 21 CFR 58.35: Quality assurance unit.
  858. PSUSA/00001350/202209 - periodic safety update report single assessment
  859. First treatment for rare condition primary hyperoxaluria type 1
  860. ema-bepranaBeprana
  861. Galantamine Stada - referral
  862. Guidance for the application of Article 34 of Regulation (EU) 2019/6 - prescription status
  863. cdsco-qhpv-vaccineqHPV Vaccine
  864. Closer ties on medicines safety between European and Canadian regulatory authorities
  865. 21 CFR 25.45: Responsible agency official.
  866. 2009 European Medicines Agency minor use minor species info day: Procedural advice for…
  867. 21 CFR 882.4500: Cranioplasty material forming instrument.
  868. 21 CFR 4.3: What current good manufacturing practice requirements apply to my combination…
  869. cdsco-pf-06823859PF-06823859
  870. Committee for Medicinal Products for Human Use (CHMP): 09-12 October 2023
  871. EMA working on COVID-19 during closure on 27 April 2021
  872. Pertuzumab And Trastuzumab
  873. EU/3/22/2580 - orphan designation for treatment of pyruvate kinase deficiency
  874. Proposal invited for designation of Central Medical Device testing lab for Medical devices…
  875. 21 CFR 890.5250: Moist steam cabinet.
  876. Vaccine safety - patient factsheet
  877. EMEA-001588-PIP03-18 - paediatric investigation plan
  878. cfr-21-cfr-820-25-personnel21 CFR 820.25: Personnel.
  879. EMEA-000845-PIP01-10-M02 - paediatric investigation plan
  880. Use of phthalates as excipients in human medicinal products - Scientific guideline
  881. Extrapolation of data from adults to children can facilitate development of paediatric…
  882. AAMI Welcomes New Editorial Board Members for 2022
  883. EU/3/12/977 - orphan designation for treatment of adrenal cortical carcinoma
  884. SAR440340/REGN3500/itepekimab (anti-IL-33 mAb)
  885. EU/3/08/565 - orphan designation for treatment of acute respiratory distress syndrome…
  886. ema-sunitinib-accordSunitinib Accord
  887. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 October 2018
  888. FDA’s First Director of Medical Device Cybersecurity, Kevin Fu, Looks to Critical Threats
  889. EMA Committee for Advanced Therapies elects Ilona Reischl as its new Chair
  890. Zika virus infection: plasma- and urine-derived medicines safe to use
  891. EMA Management Board elects Lorraine Nolan as chair
  892. Specification for Rapidly Manufactured CPAP System to be used during the coronavirus…
  893. EU/3/05/303 - orphan designation for treatment of anal fistula
  894. cdsco-baricitinibBaricitinib
  895. Methodological issues in confirmatory clinical trials planned with an adaptive design…
  896. EMEA-001750-PIP01-15-M06 - paediatric investigation plan
  897. European Medicines Agency reminds marketing-authorisation holders about requirement for…
  898. ema-deferiprone-lipomedDeferiprone Lipomed
  899. PSUSA/00001160/201611 - periodic safety update report single assessment
  900. ema-tandemactTandemact
  901. Concept paper on pharmacovigilance implementing measures released for consultation
  902. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - August 2019
  903. EU/3/13/1117 - orphan designation for treatment of Stargardt's disease
  904. EU/3/17/1922 - orphan designation for treatment of acute myeloid leukaemia
  905. EMEA-002012-PIP01-16-M03 - paediatric investigation plan
  906. EU/3/01/039 - orphan designation for treatment of soft tissue sarcoma
  907. Management Board meeting: 4-5 March 2009
  908. Paediatric Committee (PDCO): 25-28 June 2019
  909. Thrombin alfa - paediatric investigation plan
  910. Nulojix - direct healthcare professional communication (DHPC)
  911. EU/3/20/2340 - orphan designation for diagnosis of corticobasal degeneration
  912. EU/3/23/2822 - orphan designation for treatment of Kleine Levin syndrome
  913. 21 CFR 888.3680: Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
  914. PSUSA/00000110/201601 - periodic safety update report single assessment
  915. PSUSA/00002269/202105 - periodic safety update report single assessment
  916. Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA…
  917. EU/3/21/2518 - orphan designation for treatment of pancreatic cancer
  918. Betamethasone dipropionate Ph. Eur + Calcipotriol anhydrous Ph. Eur. Cutaneous spray…
  919. Drug Alert list for month of August 2015
  920. EMEA-000512-PIP01-08 - paediatric investigation plan
  921. Committee for Advanced Therapies (CAT): 15-17 May 2023
  922. European Medicines Agency and European Commission renew confidentiality arrangement with…
  923. Committee for medicinal products for veterinary use: Meeting of 11-13 December 2007
  924. 21 CFR 870.4370: Roller-type cardiopulmonary bypass blood pump.
  925. EMEA-001680-PIP01-14 - paediatric investigation plan
  926. Publice Notice dated 10.12.2021
  927. ema-teriparatide-sunTeriparatide Sun
  928. Committee for medicinal products for veterinary use: Meeting of 12 to 14 October 2004
  929. ema-pramipexole-tevaPramipexole Teva
  930. Notice regarding checklist
  931. ema-activelle-referralActivelle - referral
  932. EMEA-002362-PIP02-19-M02 - paediatric investigation plan
  933. ICH: M 4: Common technical document for the registration of pharmaceuticals for human use…
  934. Jeanine Beisel: Going Behind the Scenes in a Modern Hospital
  935. ema-kynamroKynamro
  936. Darunavir Viatris (previously Darunavir Mylan)
  937. The Computer in FDA Regulated Industries
  938. Workshop on viral safety of plasma-derived medicinal products with respect to hepatitis E…
  939. EU/3/23/2843 - orphan designation for treatment of Niemann-Pick's disease, type C
  940. 6th October 2005 (SO 1468(E)
  941. Remicade / Flixabi / Inflectra / Remsima / Zessly - direct healthcare professional…
  942. PSUSA/00003162/201801 - periodic safety update report single assessment
  943. EU/3/17/1835 - orphan designation for treatment of epidermolysis bullosa
  944. PSUSA/00000804/201702 - periodic safety update report single assessment
  945. Notice regarding for online BA/BE for Export
  946. 21 CFR 892.1350: Nuclear scanning bed.
  947. RepliGen Europe Limited withdraws its marketing authorisation application for SecreFlo…
  948. First guidance on new rules for certain medical devices
  949. Carbon Ion Therapy System Approved for Marketing
  950. European Medicines Agency: Committee for Medicinal Products for Human Use 13-16 September…
  951. Inviting comments on standard IVD evaluation protocol drafted by ICMR and CDSCO 2
  952. Paediatric Committee (PDCO): 8-11 September 2026
  953. FDA Reminds Owners and Operators About Repair and Maintenance of Tanning Beds and Booths…
  954. Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain…
  955. Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419
  956. cdsco-rituximabRituximab
  957. PRAC: Committee agendas, minutes and meeting highlights report archive 2012-2013
  958. 21 CFR 888.5980: Manual cast application and removal instrument.
  959. Committee for Medicinal Products for Veterinary Use (CVMP): 21-23 January 2020
  960. European Medicines Agency publishes report on conflicts of interests workshop
  961. PSUSA/00002601/202110 - periodic safety update report single assessment
  962. Advisory regarding Oxygen Concentrators suitable for COVID-19 case management in Home…
  963. cdsco-mezigdomide-cc-92480Mezigdomide (CC-92480)
  964. EMEA-002931-PIP01-20 - paediatric investigation plan
  965. 21 CFR 801.4: Meaning of intended uses.
  966. EMA celebrates ten years of its patients and consumers working party
  967. EMA business hours over All Saints' Day and All Souls' Day, 1 and 2 November
  968. Committee for Orphan Medicinal Products (COMP): 4-5 May 2011
  969. PSUSA/00002893/201802 - periodic safety update report single assessment
  970. 2-Deoxy-D-Glucose Oral Powder 2.34 gm & 3.0 gm
  971. Procedure on the publication of Committee on Herbal Medicinal Products public statements…
  972. cfr-21-cfr-830-3-definitions21 CFR 830.3: Definitions.
  973. Follow up information session on the TransCelerate initiative
  974. EU/3/20/2326 - orphan designation for treatment of Gaucher disease
  975. 2021.04.08_S.O. 1521(E)_Amendment of S.O. 2808(E) dt 30.11.2012 for including three more…
  976. EMEA-002048-PIP02-18 - paediatric investigation plan
  977. Paediatric Committee (PDCO): 11-14 December 2018
  978. Remdesivir for Injection 100mg/ml
  979. Chapter 1.1 - Submission Type Guidance Northern Ireland: Chapter 1.1 - Submission Type…
  980. 21 CFR 866.5750: Radioallergosorbent (RAST) immunological test system.
  981. ema-neulastaNeulasta
  982. ema-skyclarysSkyclarys
  983. ema-dasatinib-accordDasatinib Accord
  984. EMA Management Board: highlights of October 2016 meeting
  985. 21 CFR 830.130: Suspension or revocation of the accreditation of an issuing agency.
  986. List of Private drugs testing laboratories approved in form 37 of schedule A of drugs and…
  987. Eleventh EMA human scientific committees' working party with patients' and consumers'…
  988. 21 CFR 886.1400: Maddox lens.
  989. EMEA-001957-PIP02-19 - paediatric investigation plan
  990. January 31 2017 GSR 76(E)
  991. 21 CFR 17.45: Initial decision.
  992. 21 CFR 870.1280: Steerable catheter.
  993. Industry stakeholder meeting on Brexit and operation of the centralised procedure for…
  994. Chapter 7 - Annual Reporting Guidance Northern Ireland
  995. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 6) Regulations…
  996. NMPA Announcement on Issuing the Provisions for the Change Management of Post-approval…
  997. Temperature Sensors in the Regulated Industry

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