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Global regulations and guidance

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

  1. Drugs Alert for the month of February 2016
  2. Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and…
  3. ema-iqirvoIqirvo
  4. ema-apoquelApoquel
  5. ema-abilifyAbilify
  6. cdsco-2006-20082006-2008
  7. EMEA-002118-PIP01-17 - paediatric investigation plan
  8. 21 CFR 876.5012: Biliary stent, drain, and dilator accessories.
  9. Availability of veterinary vaccines
  10. EMEA-000552-PIP01-0 - paediatric investigation plan
  11. CHMP: meeting archive 2016-2018
  12. AU G0019.4.004 Guidelines NC Grading Exchange Form
  13. Flow of Complaints Handling
  14. Workshop on regulatory support for development of orphan medicines
  15. PSUSA/00001459/201706 - periodic safety update report single assessment
  16. 21 CFR 884.5250: Cervical cap.
  17. PSUSA/00010163/202108 - periodic safety update report single assessment
  18. Nonacog Alfa(recombinant coagulation factor IX
  19. cdsco-denosumabcuraDenosumabcura
  20. cdsco-lee011-nsaiLEE011 NSAI
  21. 21 CFR 868.1860: Peak-flow meter for spirometry.
  22. EU/3/11/892 - orphan designation for treatment of 5q spinal muscular atrophy
  23. EU/3/14/1333 - orphan designation for treatment of cystic fibrosis
  24. Update on the implementation of EMA policy on publication of clinical data (Policy 0070)…
  25. Questions and answers on quality of herbal medicinal products/traditional herbal medicinal…
  26. Single-use medical devices: re-manufacture of Single-use devices
  27. cdsco-june-16-2009-g-s-r-354June 16, 2009 (G.S.R.354)
  28. Guidance for Evaluation of Three-dimensional Additive Manufacturing Technology-Based…
  29. EMEA-002575-PIP02-20 - paediatric investigation plan
  30. Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 May 2020
  31. What Earns a Foundation Grant? Two-Time Recipient Shares Her Success
  32. Handling of Changes to COVID-19 Vaccine Strains (Notification)
  33. CHMP meets to discuss Multaq
  34. cdsco-cbt-001CBT-001
  35. Prevymis - opinion on variation to marketing authorisation
  36. cdsco-ozenoxacin2Ozenoxacin2
  37. 12018.12.12_Final_GSR 1193(E)_Fee Revision for registration and import license under D and…
  38. ema-eporatioEporatio
  39. GN-22 R8 Guidance for Dealers on Class A Medical Devices (Jul 2025) PUB
  40. nbcg-survey-2022-20230411Survey-2022-20230411
  41. Use of ionizing radiation in the manufacture of medicinal products - Scientific guideline
  42. PSUSA/00002555/202211 - periodic safety update report single assessment
  43. First European Medicines Agency and Affordable Medicines Europe bilateral meeting
  44. Committee for Orphan Medicinal Products (COMP): 6-7 July 2011
  45. EMEA-002706-PIP01-19-M01 - paediatric investigation plan
  46. EMA Management Board elects Christa Wirthumer-Hoche as chair
  47. Bilastine + Montelukast sodium IP eq. to Montelukast IP per 5ml oral suspension (Phase…
  48. European Medicines Agency launches electronic application form pilot
  49. Ilaris - withdrawal of application for variation to marketing authorisation
  50. European Medicines Agency recommends approval of Tafinlar for the treatment of metastatic…
  51. 21 CFR 892.1180: Bone sonometer.
  52. Committee for Orphan Medicinal Products (COMP): 12-14 March 2024
  53. EMEA-002822-PIP01-20 - paediatric investigation plan
  54. AAMI ST98: The First Cleaning Validation Standard for Medical Device Manufacturers
  55. 21 CFR 803.33: If I am a user facility, what must I include when I submit an annual…
  56. EU/3/21/2429 - orphan designation for treatment of neuroblastoma
  57. ema-loxitabLoxitab
  58. ema-vanflytaVanflyta
  59. ema-networksNetworks
  60. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26…
  61. ema-triumeqTriumeq
  62. EU/3/20/2374 - orphan designation for treatment of glioma
  63. ema-entacapone-orionEntacapone Orion
  64. EU/3/13/1156 - orphan designation for prevention of hepatitis-B re-infection following…
  65. No new patients should start treatment with Lartruvo after study shows cancer medicine…
  66. 21 CFR 809.4: Confidentiality of submitted information.
  67. cdsco-factorviiiFactorVIII
  68. cdsco-durvalumabDurvalumab
  69. PSUSA/00010570/202002 - periodic safety update report single assessment
  70. European Medicines Agency's Management Board nominates Guido Rasi as new Executive…
  71. 21 CFR 866.3956: Human immunodeficiency virus (HIV) serological diagnostic and/or…
  72. International regulators stress continued need for COVID-19 therapeutics
  73. NMPA Issued the Announcement on Issues Pertaining to the Implementation of the Newly…
  74. EMEA-000980-PIP02-15 - paediatric investigation plan
  75. Cerdelga recommended for approval in type 1 Gaucher disease
  76. ema-cimziaCimzia
  77. European Shortages Monitoring Platform
  78. Committee for Orphan Medicinal Products (COMP): 20-22 January 2020
  79. Equiseti herba - herbal medicinal product
  80. EU/3/04/250 - orphan designation for treatment of mantle cell lymphoma
  81. ema-nimenrixNimenrix
  82. 21 CFR 874.3: Effective dates of requirement for premarket approval.
  83. ema-vitraganVitragan
  84. Epoetin theta - paediatric investigation plan
  85. NMPA CDE Announcement on Issuing the Patient-Centered Action for Rare Diseases…
  86. Amended Checklist for test License Applications Effective From 15 June2011
  87. 21 CFR 73.40: Dehydrated beets (beet powder).
  88. Committee for veterinary medicinal products: 48th meeting
  89. EU/3/20/2362 - orphan designation for treatment of X-linked severe combined…
  90. 21 CFR 20.50: Nonspecific and overly burdensome requests.
  91. cdsco-nitric-oxideNitric oxide
  92. 21 CFR 890.5710: Hot or cold disposable pack.
  93. EMEA-000997-PIP01-10-M06 - paediatric investigation plan
  94. Meeting of the EMEA working party on herbal medicinal products 1 - 2 April 2004
  95. Product information: Reference documents and guidelines
  96. Regulatory information - 1.6% increase in fees from 1 April 2020
  97. Review of the manufacture of Baxter's peritoneal dialysis solutions initiated over…
  98. EMEA-002954-PIP02-21 - paediatric investigation plan
  99. PSUSA/00001263/201507 - periodic safety update report single assessment
  100. ema-neoclaritynNeoclarityn
  101. EU/3/12/986 - orphan designation for treatment of systemic sclerosis
  102. Mycobacterium w (Heat Killed) Injection1
  103. ema-sortis-referralSortis - referral
  104. AAMI and ASTM Host Standards Workshop
  105. NMPA Issues Guidelines for Evaluation of Changes in Raw Materials of Passive Medical…
  106. ema-fymskinaFymskina
  107. New AI Risk Management Framework Isn’t Suited for Medical Devices, Say Industry Leaders
  108. EMA business hours over Assumption Day, 15 August
  109. Electronic product information (ePI)
  110. Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 February 2018
  111. Clinical Trials Information System (CTIS): Walk-in clinic - November 2022
  112. EMEA-002751-PIP01-19 - paediatric investigation plan
  113. Including IVD medical devices in the ARTG
  114. EU/3/19/2158 - orphan designation for treatment of pulmonary arterial hypertension
  115. 21 CFR 886.4445: Permanent magnet.
  116. Mirabegron (ER) + Solifenacin Succinate IP film coated bilayered tablet (Phase IV
  117. Additional FAQ on New Drugs and Clinical Trial Rules, 2019
  118. Veterinary post-authorisation guidance updated with new sections and questions
  119. PSUSA/00001903/201605 - periodic safety update report single assessment
  120. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 September 2026
  121. EMEA-001494-PIP01-13 - paediatric investigation plan
  122. EU/3/23/2802 - orphan designation for treatment of acute lymphoblastic leukaemia
  123. 21 CFR 58.185: Reporting of nonclinical laboratory study results.
  124. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare…
  125. Salicis cortex - herbal medicinal product
  126. 21 CFR 814.19: Product development protocol (PDP).
  127. Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2020
  128. ema-vyvgartVyvgart
  129. eSubmission web client for electronic submissions now available for registration
  130. EU/3/06/358 - orphan designation for treatment of multiple myeloma
  131. EU/3/22/2723 - orphan designation for treatment of ovarian cancer
  132. Assessment of genotoxicity of herbal substances/preparations - Scientific guideline
  133. EU/3/20/2357 - orphan designation for treatment of oesophageal cancer
  134. English Translations of the Guidance for Establishing Safety in First-in-Human Studies…
  135. PSUSA/00002673/201506 - periodic safety update report single assessment
  136. Allii sativi bulbus - herbal medicinal product
  137. EMEA-001084-PIP02-11 - paediatric investigation plan
  138. cfr-21-cfr-3-2-definitions21 CFR 3.2: Definitions.
  139. Mary Logan: There Is No Such Thing as Free
  140. cdsco-cls-ta-sapphireCLS-TA Sapphire
  141. ema-adrovanceAdrovance
  142. Common issues identified during clinical trial applications
  143. Committee for Advanced Therapies (CAT): 11-12 September 2024
  144. GN-15-R13 Guidance on Medical Device Product Registration (2026 Mar) PUB
  145. Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway
  146. PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in…
  147. Post-notice of compliance changes: Quality document - guidance document
  148. European Medicines Agency response to European Ombudsman letter regarding proactive…
  149. Jcovden (previously COVID-19 Vaccine Janssen) - direct healthcare professional…
  150. 21 CFR 884.2675: Fetal scalp circular (spiral) electrode and applicator.
  151. 21 CFR 878.4825: General laparoscopic power morcellation containment system.
  152. PSUSA/00002275/201912 - periodic safety update report single assessment
  153. EU/3/04/204 - orphan designation for treatment of Gram-negative bacterial lung infection…
  154. cdsco-doxycyclineDoxycycline
  155. Montelukast sodium eq. to Montelukast IP + Bilastine film coated tablet (Phase III…
  156. Venous Stent System Approved for Marketing
  157. EMEA-000816-PIP02-10-M03 - paediatric investigation plan
  158. 21 CFR 884.1660: Transcervical endoscope (amnioscope) and accessories.
  159. EMEA-001968-PIP01-16 - paediatric investigation plan
  160. PSUSA/00000294/201809 - periodic safety update report single assessment
  161. Imfinzi - opinion on variation to marketing authorisation
  162. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May…
  163. PSUSA/00010245/201509 - periodic safety update report single assessment
  164. cdsco-alteplasealteplase
  165. ema-verquvoVerquvo
  166. ema-riluzole-zentivaRiluzole Zentiva
  167. 21 CFR 884.4260: Hygroscopic Laminaria cervical dilator.
  168. Committee for Herbal Medicinal Products (HMPC): 5-6 May 2014
  169. Appendix 4 Sample Verification Document for Translator
  170. Venclyxto - direct healthcare professional communication (DHPC)
  171. ema-advagrafAdvagraf
  172. 21 CFR 870.4240: Cardiopulmonary bypass heat exchanger.
  173. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28…
  174. Drug Alert list for month of February 2021
  175. ENZ110 (similar biologic of Romiplostim)
  176. Combination: Valerianae radix and Lupuli flos - herbal medicinal product
  177. 21 CFR 886.5918: Rigid gas permeable contact lens care products.
  178. PSUSA/00000616/202312 - periodic safety update report single assessment
  179. Applying for orphan designation
  180. PSUSA/00000293/202101 - periodic safety update report single assessment
  181. Valerianae aetheroleum - herbal medicinal product
  182. 21 CFR 886.4150: Vitreous aspiration and cutting instrument.
  183. Referral procedures: veterinary medicines
  184. ema-cellceptCellCept
  185. 21 CFR 864.7525: Heparin assay.
  186. Tobramycin VVB and associated names - referral
  187. EMEA-002597-PIP07-21 - paediatric investigation plan
  188. EU/3/13/1157 - orphan designation for treatment of follicular lymphoma
  189. Organization of Voluntary Blood Donation Day Camp in Nirman Bhawan Premises on 01.10.2021…
  190. 21 CFR 874.1500: Gustometer.
  191. Meeting highlights from the Committee for Medicinal Products for Human Use,18-21 June 2007
  192. 21 CFR 872.6710: Boiling water sterilizer.
  193. Donald Armstrong: The Lessons We Can Learn from New Employees
  194. EMEA-001045-PIP04-18 - paediatric investigation plan
  195. 21 CFR 890.5290: Shortwave diathermy.
  196. EMEA-002668-PIP01-19 - paediatric investigation plan
  197. EU/3/10/813 - orphan designation for treatment of metachromatic leukodystrophy
  198. European Medicines Agency to continue to involve patients in scientific discussions on…
  199. GD211 Training, Module 5 - Conclusions
  200. ema-aubagioAubagio
  201. EU/3/22/2644 - orphan designation for treatment of invasive candidiasis
  202. EU/3/01/071 - orphan designation for treatment of severe myoclonic epilepsy in infancy
  203. Paediatric Committee (PDCO): 14-17 December 2021
  204. cdsco-nucleocapsidNucleocapsid
  205. 21 CFR 73.1646: Bronze powder.
  206. Australian Government response to the Senate Community Affairs References Committee report
  207. EU/3/06/428 - orphan designation for treatment of cutaneous T-cell lymphoma
  208. EU/3/16/1746 - orphan designation for treatment of metaphyseal chondrodysplasia, Schmid…
  209. Joint NB Spinal Classification Decision Tree_final
  210. Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
  211. Clinical evaluation of medicinal products used in weight control - Scientific guideline
  212. PSUSA/00002896/201709 - periodic safety update report single assessment
  213. EU/3/16/1819 - orphan designation for treatment of medulloblastoma
  214. ema-zenapaxZenapax
  215. Grant of manufacturing licences for Large Volume Parenterals (Form 28D/Form 28DA) and…
  216. EU/3/07/479 - orphan designation for treatment of tuberculosis
  217. Scientific workshop on serology assays and correlates of protection for influenza vaccines
  218. Lyophilization of Parenterals (7/93
  219. Acrylic acid derivatives, which includes di-, tri- and glycerol methacrylates, often used…
  220. Adaptive Platform Treatment Trial
  221. Overkilling Uncertainty, New TIR Seeks Clarity for Interpreting Bioburden Data
  222. Guidance document for obtaining Market Standing Certificate & Non conviction certificate…
  223. aami-2018-the-year-in-review2018—The Year in Review
  224. Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety…
  225. Legal framework: Pharmacovigilance
  226. EU/3/07/455 - orphan designation for prevention of corneal graft rejection
  227. ema-opaxioOpaxio
  228. Template for a European Union list entry
  229. 21 CFR 866.5775: Rheumatoid factor immunological test system.
  230. 21 CFR 862.3680: Primidone test system.
  231. 21 CFR 74.2708: D&C Yellow No. 8.
  232. Notice regarding sugam blood products dated 19.09.2018
  233. EMEA-002243-PIP01-17-M03 - paediatric investigation plan
  234. Committee for Advanced Therapies (CAT): 12-13 May 2011
  235. ema-lorviquaLorviqua
  236. 21 CFR 886.4360: Ocular surgery irrigation device.
  237. PSUSA/00010525/202104 - periodic safety update report single assessment
  238. 21 CFR 886.5300: Tear electrostimulation device.
  239. Applications Now Available for Sterilization Research and Student Funding, 2024
  240. PSUSA/00000449/201604 - periodic safety update report single assessment
  241. EMEA-001428-PIP01-13 - paediatric investigation plan
  242. ema-support-to-smesSupport to SMEs
  243. EU/3/08/570 - orphan designation for prevention of delayed graft function after solid…
  244. European Medicines Agency issues recommendations for 2013/2014 seasonal flu vaccine…
  245. EMEA-000625-PIP01-09-M03 - paediatric investigation plan
  246. EU/3/23/2785 - orphan designation for treatment of recurrent respiratory papillomatosis
  247. 21 CFR 870.1140: Venous blood pressure manometer.
  248. William Hyman: Will Unique Device Identifiers Live Up to the Hype?
  249. UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: November 19, 2024: Joint…
  250. PSUSA/00010542/202212 - periodic safety update report single assessment
  251. EMEA-003063-PIP01-21 - paediatric investigation plan
  252. Switching between superiority and non-inferiority - Scientific guideline
  253. EMEA-003009-PIP01-21 - paediatric investigation plan
  254. 2011 annual workshop of the European Network of Paediatric Research at the European…
  255. PSUSA/00002411/201803 - periodic safety update report single assessment
  256. EMEA-001180-PIP01-11 - paediatric investigation plan
  257. 21 CFR 868.5995: Tee drain (water trap).
  258. EMEA-000556-PIP01-09-M02 - paediatric investigation plan
  259. EU/3/21/2421 - orphan designation for treatment of cystic fibrosis
  260. Aceclofenac IP + Linceed Oil (containing predominantly-Linolenic acid) + Methyl Salicylate…
  261. EMEA-002936-PIP01-20 - paediatric investigation plan
  262. BMS-986510 (KarXT) (Xanomeline+Trospium Chloride)
  263. European Medicines Agency welcomes new Head of Administration
  264. EU/3/16/1801 - orphan designation for treatment of amyotrophic lateral sclerosis
  265. Use of macrolides, lincosamides and streptogramins in food-producing animals in the…
  266. Kilmer Fund Recipient Repurposes Materials Used in Space for Safer Medical Devices
  267. PSUSA/00010377/201604 - periodic safety update report single assessment
  268. 21 CFR 866.3140: Corynebacterium spp. serological reagents.
  269. EMEA-000753-PIP02-16 - paediatric investigation plan
  270. Patient registries workshop
  271. Review of pholcodine medicines started
  272. ema-niapelfNiapelf
  273. 21 CFR 19.55: Permanent disqualification of former employees.
  274. Compendial Methods Assessment
  275. Paediatric Committee (PDCO): 25-28 June 2019
  276. European Medicines Agency releases updated guidance on insomnia treatments
  277. COVID-19 vaccines approved in the country as on 04.10.2022
  278. cdsco-dienogest-2mg-tabletDienogest 2mg Tablet
  279. Protelos - withdrawal of application for variation to marketing authorisation
  280. 34th meeting of the committee for veterinary medicinal products
  281. ema-efficacy-working-partyEfficacy Working Party
  282. EMEA-000645-PIP01-09-M08 - paediatric investigation plan
  283. Ranbaxy, Toansa assessment concluded: no risk to public health
  284. EU/3/14/1411 - orphan designation for treatment of interstitial cystitis
  285. Development of medicinal products for the treatment of post-traumatic stress disorder…
  286. EU/3/09/626 - orphan designation for treatment of myelodysplastic syndromes
  287. Early dialogue between regulators and health technology assessment bodies key to medicines…
  288. PSUSA/00002209/202110 - periodic safety update report single assessment
  289. ema-raxoneRaxone
  290. Vaccines and Related Biological Products Advisory Committee March 3, 2022 Meeting…
  291. In Italy, Simulation Builds Skills Against Cybersecurity Attacks
  292. Ch. 10 - Other Procedures
  293. Budesonide/Formoterol Teva
  294. New Collaboration Between AAMI, Archimedes Center Promises Greater Innovation in Medical…
  295. ema-diabetesDiabetes
  296. ema-cozaar-referralCozaar - referral
  297. EMEA-000317-PIP02-18-M01 - paediatric investigation plan
  298. ema-irbesartan-bmsIrbesartan BMS
  299. Drug Alert for the month of June,2018
  300. ema-arixtraArixtra
  301. PSUSA/00000536/202104 - periodic safety update report single assessment
  302. Vaccines and Related Biological Products Advisory Committee March 7, 2023 Meeting…
  303. European Medicines Agency closed 1 May 2019
  304. Leak Testing Sealed Ampuls of Parenteral Solutions
  305. 21 CFR 886.5201: Intense pulsed light device for managing dry eye.
  306. 21 CFR 868.5560: Gas mask head strap.
  307. cdsco-crovalimabCrovalimab
  308. Type II variations: Regulatory and procedural guidance
  309. Tedizolid phosphate Tablets and Injection
  310. Assessment and procurement of coronavirus (COVID-19) tests: Technical validation protocol…
  311. Committee for Medicinal Products for Human Use (CHMP): 29 March – 01 April 2016
  312. ema-doxyfar-50-referralDoxyfar 50% - referral
  313. PSUSA/00001351/201409 - periodic safety update report single assessment
  314. When Is Cloud Technology Appropriate? Best Practices for Medical Devices
  315. EMEA-003262-PIP01-22 - paediatric investigation plan
  316. EU/3/20/2317 - orphan designation for treatment in haematopoietic stem cell…
  317. 2018.07.30_Draft_GSR 719(E)_ Exemption of parenteral sterile solutions with 100 mL…
  318. Drug Alert list for month of January 2016
  319. Medical devices: UK approved bodies: BSI Assurance UK Ltd Active Implantable Medical…
  320. Nov 07.11.2013 GSR 724(E)
  321. EMEA-002955-PIP01-21 - paediatric investigation plan
  322. StMP Future Proofs AAMI Standards Development with Partner Edaptive Technologies
  323. ema-exparel-liposomalExparel liposomal
  324. EMEA-000916-PIP01-10-M07 - paediatric investigation plan
  325. ema-ypozaneYpozane
  326. Notice Order regarding Import of Cosmetic division Sugam Online
  327. Third Veterinary Big Data Stakeholder Forum
  328. BE-NOC Prior Intimation (System of Notification for certain category of new drugs for…
  329. What's New in the Sterile Processing Field? Updates from HSPA 2023
  330. Electronic submission of individual case safety reports
  331. Bilastine IP 3.3mg + Phenylephrine Hydrochloride IP 5mg + Dextromethorphan Hydrobromide IP…
  332. Drug Alert for the Month of November 2024
  333. Trastuzumab Deruxtecan (T-DXd, DS-8201a)
  334. AAMI Exchange to Offer Several Sessions on Sterilization
  335. COVID-19: EMA recommends authorisation of antibody medicine Xevudy
  336. 21 CFR 886.1150: Visual acuity chart.
  337. 21 CFR 866.3135: Coccidioides immitis serological reagents.
  338. Guide to Information held by the HPRA
  339. cdsco-qmf149QMF149
  340. ema-exelonExelon
  341. EMEA-002004-PIP01-16 - paediatric investigation plan
  342. QA on Traceability of Medicinal Gases
  343. PSUSA/00002893/202102 - periodic safety update report single assessment
  344. 21 CFR 876.5130: Urological catheter and accessories.
  345. Brilique - withdrawal of application for variation to marketing authorisation
  346. William Hyman: UDI Database Offers Roller Coaster Experience with Device Descriptions
  347. EMEA-001421-PIP01-12 - paediatric investigation plan
  348. PSUSA/00001396/202206 - periodic safety update report single assessment
  349. Guide to distributing drugs intended for the Canadian market for consumption or use…
  350. EU/3/09/666 - orphan designation for treatment of familial adenomatous polyposis (FAP)
  351. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20…
  352. COVID-19 Medical Device Establishment Licence (MDEL) supensions
  353. EU/3/21/2484 - orphan designation for treatment of Rett syndrome
  354. Industry stakeholder webinar on the UK withdrawal from the European Union - End of…
  355. Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF)
  356. Quadrivalent Meningococcal Conjugate Vaccine
  357. cdsco-nebulized-pc945nebulized PC945
  358. 21 CFR 74.2602: D&C Violet No. 2.
  359. ema-quality-stabilityQuality: stability
  360. cdsco-roxadustat-anemiaRoxadustat Anemia
  361. EU/3/04/259 - orphan designation for treatment of idiopathic pulmonary fibrosis
  362. Tech World: The Importance of Drying Flexible Endoscopes
  363. EMEA-001176-PIP01-11-M06 - paediatric investigation plan
  364. ema-instanylInstanyl
  365. Basic Principles on Global Clinical Trials (Reference Cases)
  366. cfr-21-cfr-82-50-general21 CFR 82.50: General.
  367. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  368. Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI workshop…
  369. First Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical…
  370. EMEA-001079-PIP01-10-M06 - paediatric investigation plan
  371. ema-esmyaEsmya
  372. Guidance on how to complete the application for a new medical device licence
  373. EU/3/11/899 - orphan designation for treatment of multiple myeloma
  374. Tocilizumab Injection[180mg/mL PrefilledSyringes(162mg/0.9mL)
  375. cdsco-ticagrelorTicagrelor
  376. EMEA-003065-PIP01-21 - paediatric investigation plan
  377. European Medicines Agency focuses on new legislation, increased efficiency and…
  378. ema-ivemendIvemend
  379. Paediatric Committee (PDCO): 20-23 February 2018
  380. 20th meeting of the Committee for Orphan Medicinal Products
  381. DR_G.S.R. 191(E) dt_05.03.2003_26A_reg Astemizole and Terfinadine
  382. 21 CFR 888.1250: Nonpowered dynamometer.
  383. Meeting highlights from the Paediatric Committee:12 - 14 November 2008
  384. International Women’s Day 2023: #EmbraceEquity
  385. European Medicines Agency closed 1-2 November 2012
  386. EU/3/12/975 - orphan designation for treatment of Prader-Willi syndrome
  387. Follicle-Stimulating Hormone and Human Chorionic Gonadotropin
  388. ema-pioglitazone-ratiopharmPioglitazone ratiopharm
  389. 21 CFR 864.9700: Blood storage refrigerator and blood storage freezer.
  390. cdsco-ruxolitinibRuxolitinib
  391. PSUSA/00010312/202001 - periodic safety update report single assessment
  392. Surrender of Cosmetics Import Registration Certificates of M/s Johnson & Johnson Pvt. Ltd…
  393. ema-calcium-sandoz-referralCalcium Sandoz - referral
  394. PSUSA/00001955/202302 - periodic safety update report single assessment
  395. Drug Alert list for month of May 2020
  396. First EMA workshop on non-animal approaches in support of medicinal product development…
  397. 21 CFR 74.3045: [Phthalocyaninato(2-)] copper.
  398. EU/3/10/802 - orphan designation for treatment of idiopathic pulmonary fibrosis
  399. cdsco-july-31-2015-gsr-611-eJuly 31 2015 GSR 611(E)
  400. Aug_28,2009(G.S.R_607(E)
  401. ema-riltrava-aerosphereRiltrava Aerosphere
  402. Lenvatinib 4/10 mg Capsule
  403. FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings…
  404. PSUSA/00002392/202008 - periodic safety update report single assessment
  405. Valproat Ratiopharm Chrono - referral
  406. ema-beromunBeromun
  407. PSUSA/00003163/201703 - periodic safety update report single assessment
  408. Notice regarding Examination for safety and efficacy of FDCs Licensed for manufacture for…
  409. Ambient voice technology-enabled products
  410. Clinical trials with haematopoietic growth factors for the prophylaxis of infection…
  411. PSUSA/00010579/202103 - periodic safety update report single assessment
  412. EU/3/16/1783 - orphan designation for treatment of acute pancreatitis
  413. PSUSA/00002254/202204 - periodic safety update report single assessment
  414. Paediatric Committee (PDCO): 12-15 October 2021
  415. EMEA-000828-PIP04-16-M03 - paediatric investigation plan
  416. 21 CFR 886.1460: Stereopsis measuring instrument.
  417. PSUSA/00010651/202205 - periodic safety update report single assessment
  418. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2019
  419. AAMI Member Company Tackles Food Desert for Future Workers
  420. EU/3/22/2732 - orphan designation for treatment of acute lymphoblastic leukaemia
  421. Therapeutic areas: latest updates
  422. Lenalidomide Celgene Europe
  423. EMEA-001365-PIP01-12 - paediatric investigation plan
  424. Pegfilgrastim 6 mg/0.6 mL single-dose prefilled syringe with an on- body injector
  425. Draft guidelines: New annex 22 - Artificial intelligence
  426. EMEA-001913-PIP02-18 - paediatric investigation plan
  427. Amantadine Extended Release Tablet 129/193 mg
  428. Bromfenac sodium sesquihydrate - paediatric investigation plan
  429. European Medicines Agency recommends approval of new HIV medicine
  430. ema-rapilysinRapilysin
  431. EMEA-002018-PIP02-16-M05 - paediatric investigation plan
  432. Alcover and associated names - referral
  433. cdsco-bi-685509BI 685509
  434. European Medicines Agency workshop on methodological aspects of clinical trials for…
  435. 21 CFR 1.622: How must a recognized accreditation body monitor its own performance?
  436. Polypropylene, often used in surgical mesh
  437. Zeleris - opinion on variation to marketing authorisation
  438. cdsco-pf-06865571PF-06865571
  439. PIC/S Work Plan for 2019
  440. Jemperli - opinion on variation to marketing authorisation
  441. NMPA Issued Three Guidelines for Technical Review of the Registration of Embryo…
  442. EMA recommends 81 medicines for marketing authorisation in 2013
  443. Tulobuterol Transdermal
  444. Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints…
  445. 21 CFR 807.22: Times for establishment registration and device listing.
  446. Get to Know the CAO: Ed Glabus, Chief Administrative Officer
  447. 21 CFR 884.3: Effective dates of requirement for premarket approval.
  448. EU/3/12/1041 - orphan designation for treatment of primary biliary cirrhosis
  449. 21 CFR 868.5975: Ventilator tubing.
  450. EU/3/24/2906 - orphan designation for treatment of fragile X syndrome
  451. EU/3/19/2153 - orphan designation for treatment of spinal cord injury
  452. GMP Clearance code tables guidance
  453. Releasing medicines manufactured at multiple sites
  454. Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 June 2013
  455. Paediatric Committee (PDCO): 16-19 May 2017
  456. Committee for Advanced Therapies (CAT): 12-14 August 2020
  457. EU/3/13/1193 - orphan designation for treatment of Allan-Herndon-Dudley syndrome
  458. PSUSA/00001075/202104 - periodic safety update report single assessment
  459. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26…
  460. EU/3/16/1768 - orphan designation for treatment of ischaemia/reperfusion injury associated…
  461. Introducing the 2023 Nominees for the AAMI Board of Directors & Nominating Committee
  462. Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication
  463. cdsco-lib003-in-heterozygousLIB003 in Heterozygous
  464. EU/3/13/1192 - orphan designation for treatment of complex regional pain syndrome
  465. ema-strongholdStronghold
  466. 21 CFR 862.2260: High pressure liquid chromatography system for clinical use.
  467. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 12-14 January 2010
  468. cdsco-peginterferonbeta-1aPeginterferonbeta-1a
  469. Artificial Intelligence versus Augmented Intelligence: What’s in a Word?
  470. Availability of Not Standard Quality (NSQ) Alert on New Link in CDSCO Website
  471. Omega-3 fatty acid medicines no longer considered effective in preventing heart disease
  472. EU/3/21/2568 - orphan designation for prevention of bronchopulmonary dysplasia
  473. EMEA-000583-PIP01-09-M08 - paediatric investigation plan
  474. Guidance for the use of medicinal cannabis in the treatment of chronic non-cancer pain in…
  475. 2024.02.06_S.O. 567(E)_Notification of Government Analysts for CDTL Indore
  476. Similar biological medicinal products containing interferon beta - Scientific guideline
  477. Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide - paediatric…
  478. European Medicines Agency recommends the approval of thalidomide for the treatment of rare…
  479. FDA Updates List of AI/ML Enabled Medical Devices
  480. EMEA-001439-PIP01-13-M03 - paediatric investigation plan
  481. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
  482. Committee for veterinary medicinal products: guidelines
  483. Revefenacin Inhalation solution 175 mcg/3ml (M/s BDR)
  484. Requirements for the production and control of immunological veterinary medicinal products…
  485. 21 CFR 890.5525: Iontophoresis device.
  486. Scientific requirements for the environmental risk assessment of gene-therapy medicinal…
  487. 21 CFR 884.5400: Menstrual cup.
  488. Guidance for companies seeking scientific support and advice on traditional herbal…
  489. Outcome report on first European collaboration between regulators and HTA organisations…
  490. The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope…
  491. Type-IB variations: questions and answers
  492. EU/3/15/1525 - orphan designation for treatment of mitochondrial trifunctional protein…
  493. EU/3/18/2081 - orphan designation for treatment of ATTR amyloidosis
  494. ema-pandemic-influenzaPandemic influenza
  495. European Medicines Agency closed 1 May 2012
  496. Biapenam Injection 300 mg
  497. ema-ondexxyaOndexxya
  498. Veterinary medicinal products containing a combination of lincomycin and spectinomycin to…
  499. ema-julucaJuluca
  500. Appendix 9A Checklist for Registration of Human Therapeutic Products Containing Materials…
  501. Tacrolimus lipid suspension 4mg/vial
  502. ema-ilumetriIlumetri
  503. cdsco-c21nC21n
  504. EU/3/04/247 - orphan designation for treatment of multiple myeloma
  505. Recombinant Hepatitis E Vaccine
  506. Medical Device Management Guideline
  507. PSUSA/00009060/201510 - periodic safety update report single assessment
  508. EMEA-002973-PIP01-21 - paediatric investigation plan
  509. FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal…
  510. ema-piroxicam-referralPiroxicam - referral
  511. AAMI News, January 2021, Vol.56, No.1
  512. Focus on innovative medicines for animals
  513. EMEA-003201-PIP01-22 - paediatric investigation plan
  514. EMEA-002023-PIP01-16-M06 - paediatric investigation plan
  515. 21 CFR 874.3315: Tympanic membrane contact hearing aid.
  516. Facial Recognition in Hospitals? Experts Weigh In
  517. Regulation on Reporting Performances of Production, Export, Import and Repair of Medical…
  518. EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against…
  519. EMEA-003121-PIP01-21 - paediatric investigation plan
  520. Single Photon Emission and X-ray Computed Tomography Imaging System Approved for Marketing
  521. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 January 2018
  522. Meeting highlights from the Committee for Medicinal Products for Human Use,16-18 October…
  523. April 13, 2017: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement…
  524. 21 CFR 882.5820: Implanted cerebellar stimulator.
  525. ema-rexxolideRexxolide
  526. Guidance document - Labelling of in vitro diagnostic devices
  527. About inspections
  528. Committee for Medicinal Products for Human Use (CHMP): 18-21 November 2013
  529. 2018.03.23_S.O.1352(E)_ Banning of Diagnostic Tests for malaria_Sec. 26(A)
  530. EMEA-001582-PIP01-13-M10 - paediatric investigation plan
  531. GMP Ministerial Ordinance (Ministerial Ordinance on Standards for Manufacturing Control…
  532. Core summary of product characteristics for human fibrinogen products - Scientific…
  533. Syringes: Current Quality & Supply Chain Concerns Follow a 2,000-Year History
  534. EU/3/06/409 - orphan designation for treatment of acute lymphoblastic leukaemia
  535. EMEA-001914-PIP01-15 - paediatric investigation plan
  536. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 March 2026
  537. Healthcare Cybersecurity amid the COVID-19 Pandemic
  538. Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic…
  539. ema-olysioOlysio
  540. PSUSA/00010651/202005 - periodic safety update report single assessment
  541. EMEA-002783-PIP01-20 - paediatric investigation plan
  542. Committee for Orphan Medicinal Products (COMP): 8-9 February 2011
  543. Magnetic Resonance Monitoring Semiconductor Laser Treatment Equipment Approved for…
  544. Ipatasertib in Combination with Paclitaxel
  545. PSUSA/00000174/202203 - periodic safety update report single assessment
  546. EMEA-002821-PIP01-20 - paediatric investigation plan
  547. ema-sovrimaSovrima
  548. Violae herba cum flore - herbal medicinal product
  549. PSUSA/00010489/201705 - periodic safety update report single assessment
  550. Reporting adverse incidents: devices for cardiac ablation
  551. Committee for Advanced Therapies (CAT): 7-9 October 2020
  552. ema-docetaxel-teva-pharmaDocetaxel Teva Pharma
  553. EMA starts rolling review of COVID-19 vaccine Vidprevtyn
  554. EMEA-002786-PIP01-20 - paediatric investigation plan
  555. Making best use of big data for public health: publication of the Big Data Steering Group…
  556. EMEA-001289-PIP01-12-M01 - paediatric investigation plan
  557. Committee for Medicinal Products for Human Use (CHMP): 24-26 April 2023
  558. EU/3/16/1776 - orphan designation for treatment of facioscapulohumeral muscular dystrophy
  559. SARS-CoV-2 Equine Antiserum Immunoglobulin (Purified F(ab)2 fragment)
  560. Medicines assessed under the ‘EU-M4all’ procedure
  561. THE DRUGS RULES 1945 dated 01-07-2024
  562. Committee for Herbal Medicinal Products (HMPC): 29-30 January 2018
  563. EMEA-001617-PIP01-14 - paediatric investigation plan
  564. 21 CFR 822.7: What should I do if I do not agree that postmarket surveillance is…
  565. EMEA-000938-PIP01-10 - paediatric investigation plan
  566. 21 CFR 800.30: Over-the-counter hearing aid controls.
  567. Initiatives to Promote Pediatric Drug Development
  568. cdsco-de-109DE-109
  569. Cladribine - paediatric investigation plan
  570. Echinaceae purpureae herba - herbal medicinal product
  571. Juglandis folium - herbal medicinal product
  572. Paediatric Committee (PDCO): 29 January-1 February 2019
  573. EU/3/23/2889 - orphan designation for treatment of thalassaemia intermedia and major
  574. FDA Investigations Operations Manual
  575. Procedure to be followed for regularization of FDCs with respect to 294 FDCs examined' by…
  576. December 27, 2011 (GSR 899(E)
  577. Report on AI Adoption Highlights Financial Future of Medtech
  578. EMEA-001739-PIP02-16-M01 - paediatric investigation plan
  579. ema-ketoconazole-hraKetoconazole HRA
  580. Topiroxostat tablets 20 mg/40mg/60 mg
  581. EMEA-003064-PIP01-21 - paediatric investigation plan
  582. EU/3/01/082 - orphan designation for treatment of acute lymphoblastic leukaemia
  583. 6th meeting of the Committee for Orphan Medicinal Products
  584. EIC / EMA Info Day: Regulatory support for the development of innovative medicines and…
  585. EU/3/17/1926 - orphan designation for treatment of ovarian cancer
  586. ema-faslodexFaslodex
  587. EU/3/21/2504 - orphan designation for treatment in haematopoietic stem cell…
  588. Emma Fauss: Remote Monitoring Is No Remote Concern for Hospitals
  589. Human Papillomavirus1 Type 6 L1 protein / Human Papillomavirus1 Type 11 L1 protein / Human…
  590. Pharmacovigilance Risk Assessment Committee (PRAC): 29-31 October 2012
  591. Management Board meeting: 16-17 December 2015
  592. EMEA-001142-PIP02-16 - paediatric investigation plan
  593. aami-one-on-one-ken-schwarzOne on One: Ken Schwarz
  594. PSUSA/00010291/201806 - periodic safety update report single assessment
  595. PSUSA/00000174/201703 - periodic safety update report single assessment
  596. ema-tulinovetTulinovet
  597. Actos - Update to ongoing safety review of Actos (pioglitazone) and increased risk of…
  598. Guideline on clinical investigation of medicinal products for the treatment of juvenile…
  599. Seventeenth Meeting of the Management Board
  600. Advice for Retailers and Producers
  601. 21 CFR 872.3630: Endosseous dental implant abutment.
  602. semaglutide versus placebo
  603. Oral Solid Dosage Forms Pre/Post Approval Issues (1/94)
  604. EMEA-002143-PIP01-17 - paediatric investigation plan
  605. May 6, 2021: Meeting of the Arthritis Advisory Committee Meeting Announcement - 05/06/2021
  606. Navigational Positioning Microwave Ablation System Approved for Marketing
  607. Lurasidone product-specific bioequivalence guidance
  608. ICH Q4B Annex 2 Test for extractable volume in parenteral preparations - Scientific…
  609. EU/3/19/2136 - orphan designation for treatment of CHARGE syndrome
  610. List of medical devices testing laboratory (MDTL) for carry out test or evaluation of…
  611. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10…
  612. EMEA-000836-PIP01-10 - paediatric investigation plan
  613. 21 CFR 73.3118: N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.
  614. Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task…
  615. cdsco-gedatolisibGedatolisib
  616. World Health Organization international consultation on regulatory systems strengthening
  617. November 16, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
  618. 2020.02.11_S.O. 648(E)_ Medical Device Definition
  619. Module 1.2.1: Assessed listed medicine general application information form
  620. 21 CFR 1.99: Costs chargeable in connection with relabeling and reconditioning…
  621. Statistical Considerations When Planning Phase I Clinical Trials in Oncology - From the…
  622. PSUSA/00002370/202001 - periodic safety update report single assessment
  623. ema-aflunovAflunov
  624. AAMI Exchange IoTXperience Demonstrates the Future of the Internet of Things
  625. cdsco-atalurenAtaluren
  626. EMA organises a second public meeting about the new COVID-19 vaccines
  627. 2019.02.08_S.O. 775(E)_ Notification of certain medical devices (8 no's) under definition…
  628. PSUSA/00010381/201804 - periodic safety update report single assessment
  629. Notice regarding Human Vaccines dated 15.02.2017
  630. Chemistry, Manufacturing and Controls Requirements for Cell, Tissue or Gene Therapy…
  631. Ask Herman 2021-04-08: The Joint Commission Answers Your Questions
  632. 21 CFR 801.16: Medical devices; Spanish-language version of certain required statements.
  633. EU/3/02/124 - orphan designation for treatment of Lambert-Eaton myasthenic syndrome
  634. PSUSA/00001127/201708 - periodic safety update report single assessment
  635. EMEA-001142-PIP01-11-M04 - paediatric investigation plan
  636. Procedure to be follow for reqularisation of 19 FDCs out of 294 FDCs which required…
  637. EMA Management Board: highlights of June 2016 meeting
  638. European Medicines Agency's Paediatric Committee: Elects its first chairand vice-chair
  639. EMEA launches Eudra Vigilance training programme
  640. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May…
  641. 2023.07.31_DR_S.O. 3448(E)_Prohibition of Veterinary Drugs Ketoprofen and its formulation…
  642. PSUSA/00000593/202106 - periodic safety update report single assessment
  643. Guidance on Risk Classification of Medical Device Observations (GUI-0079)
  644. EMEA-001371-PIP03-22 - paediatric investigation plan
  645. Management Board meeting: 15 December 2011
  646. EU/3/13/1123 - orphan designation for treatment of idiopathic pulmonary fibrosis
  647. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  648. ema-dexdorDexdor
  649. 21 CFR 866.6040: Gene expression profiling test system for breast cancer prognosis.
  650. PSUSA/00000745/201812 - periodic safety update report single assessment
  651. 2019.04.02 S.O. 1500(E) Notification of Organ Preservative solution as drug under Section…
  652. SO 2496(E) dt 03.11.2011_Notification of 19 Drugs Inspectors
  653. Guidance for Evaluation of Artificial Inteligence-Assisted Medical Imaging Systems For…
  654. 5-aminolevulinic acid hydrochloride
  655. October 11-12, 2017: Patient Engagement Advisory Committee Meeting Announcement…
  656. EMEA-002268-PIP02-18-M01 - paediatric investigation plan
  657. Sofosbuvir 400 mg Tablet
  658. European Medicines Agency update on the safety of Tamiflu
  659. Drug Alert list for month of January 2022
  660. 21 CFR 886.1380: Diagnostic condensing lens.
  661. Export drugs and medicines: special rules
  662. Foeniculi amari fructus aetheroleum - herbal medicinal product
  663. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 December 2015
  664. Metformin Hydrochloride IP (as sustained release) + Sitagliptin Phosphate Monohydrate IP…
  665. EMEA-000007-PIP01-07-M02 - paediatric investigation plan
  666. EU/3/16/1765 - orphan designation for treatment of primary coenzyme Q10 deficiency…
  667. EMEA-001051-PIP01-10-M03 - paediatric investigation plan
  668. PSUSA/00001868/202006 - periodic safety update report single assessment
  669. Workshop on development of new antibacterial medicines
  670. Doxyprex 100mg Premix - referral
  671. EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens
  672. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 November 2015
  673. Committee for Orphan Medicinal Products (COMP): 8-9 March 2011
  674. Minimising the risk of transmitting animal spongiform encephalopathy agents via human and…
  675. EMA Human Scientific Committees' Working Parties with Patients' and Consumers'…
  676. Pneumococcal Polysaccharide Conjugate Vaccine
  677. Awareness session for SMEs on the reform of the EU pharmaceutical legislation
  678. Information session on Call for Proposals "EU 4 AMA: leveraging European expertise for…
  679. 21 CFR 874.1325: Electroglottograph.
  680. EU/3/11/948 - orphan designation for treatment of 5q spinal muscular atrophy
  681. 21 CFR 71.4: Samples; additional information.
  682. PSUSA/00002503/202104 - periodic safety update report single assessment
  683. 21 CFR 58.217: Suspension or termination of a testing facility by a sponsor.
  684. PSUSA/00000902/201412 - periodic safety update report single assessment
  685. 1st EMEA workshop for patients' organisations on Orphan Medicinal Products
  686. PSUSA/00000482/201707 - periodic safety update report single assessment
  687. FXIa inhibitor asundexianBAY 2433334
  688. 20-valent Pneumococcal Conjugate (20vPnC) Vaccine
  689. Appendix 9 Guideline on the Registration of Human Therapeutic Products Containing…
  690. Biologics Working Party documents
  691. PSUSA/00002061/201807 - periodic safety update report single assessment
  692. EMEA-002506-PIP03-21 - paediatric investigation plan
  693. cdsco-fg-3019sFG-3019s
  694. PSUSA/00000616/201712 - periodic safety update report single assessment
  695. EU/3/20/2282 - orphan designation for treatment of Duchenne muscular dystrophy
  696. EU/3/13/1111 - orphan designation for treatment of chronic non-infectious uveitis
  697. EU/3/18/2059 - orphan designation for treatment of spinocerebellar ataxia
  698. PSUSA/00002662/202209 - periodic safety update report single assessment
  699. ema-policies-and-proceduresPolicies and procedures
  700. Extending the validity of Free Sale certificate for notified medical devices
  701. EMEA-002869-PIP03-21 - paediatric investigation plan
  702. cdsco-s-217622S-217622
  703. Alert_FSN-Medtronic Heartware HVAD
  704. Fourth stakeholder forum on the implementation of the new 2010 pharmacovigilance…
  705. ema-equisolonEquisolon
  706. 21 CFR 812.7: Prohibition of promotion and other practices.
  707. ema-pedeaPedea
  708. cdsco-verapamil-erVerapamil ER
  709. ema-cheristinCheristin
  710. ema-tritanrix-hepbTritanrix HepB
  711. 21 CFR 870.3925: Replacement heart valve.
  712. Certification of medicinal products
  713. EMEA-001879-PIP01-15-M03 - paediatric investigation plan
  714. State NSQ ALERT FOR THE MONTH OF JUNE 2024
  715. Paediatric Committee (PDCO): 28-31 March 2023
  716. Advice for developers of COVID-19 vaccines
  717. Child-resistant packaging requirements for medicines - Guidance on TGO 95
  718. 21 CFR 25.50: General information.
  719. Office Memorandum regarding clarification for dealing with impoted consignments of Medical…
  720. 21 CFR 866.3850: Trichinella spiralis serological reagents.
  721. cfr-21-cfr-3-3-scope21 CFR 3.3: Scope.
  722. EMEA-000971-PIP01-10-M03 - paediatric investigation plan
  723. Ninth meeting of the EMA Human Scientific Committees' Working Party with Patients' and…
  724. Psyllii semen - herbal medicinal product
  725. EMEA-002710-PIP01-19 - paediatric investigation plan
  726. Twenty-third Meeting of the Management Board
  727. Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New Drugs and…
  728. Questions and Answers (Q&A) for Designation of Orphan Drugs etc.
  729. ema-descovyDescovy
  730. Rivastigmine 3M Health Care Ltd
  731. ema-oxbryta-referralOxbryta - referral
  732. EMEA/INFARMED/EXPERTISSUES joint workshop on cell based medicinal products
  733. EU/3/11/939 - orphan designation for treatment of cutaneous T-cell lymphoma
  734. NMPA Promulgated the Technical Guidelines for Clinical Trial of Recombinant Human…
  735. PSUSA/00000605/201712 - periodic safety update report single assessment
  736. 21 CFR 26.43: Transmission of quality system evaluation reports.
  737. EU/3/17/1828 - orphan designation for treatment of cystic fibrosis
  738. EMA regular press briefing on COVID-19
  739. PSUSA/00003135/202012 - periodic safety update report single assessment
  740. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 July 2019
  741. Authorisation of medicines
  742. Advice for consumers: e-cigarette Analysis Print - guidance document
  743. ema-losec-referralLosec - referral
  744. Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very…
  745. Essential work to combat the COVID-19 pandemic to continue during EMA's Easter break from…
  746. Tygacil - withdrawal of application for variation to marketing authorisation
  747. cdsco-varespladibVarespladib
  748. EU/3/23/2752 - orphan designation for treatment of pancreatic cancer
  749. EU/3/14/1274 - orphan designation for treatment of glioma
  750. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26…
  751. Michele DeMeo: A Challenge to Sterile Processing Managers
  752. Lamivudine Teva Pharma B.V.
  753. 21 CFR 884.5320: Glans sheath.
  754. PSUSA/00002905/201804 - periodic safety update report single assessment
  755. Sartan medicines: companies to review manufacturing processes to avoid presence of…
  756. Application for a Medical Device Licence Amendment for a Private Label Medical Device
  757. PSUSA/00000799/202002 - periodic safety update report single assessment
  758. 21 CFR 82.1336: D&C Red No. 36.
  759. EU/3/14/1341 - orphan designation for treatment of cystinosis
  760. lnsulin Glargine 100U/mL
  761. EU/3/21/2439 - orphan designation for treatment of retinitis pigmentosa
  762. ema-zestril-referralZestril - referral
  763. ACTR for Safety and Efficacy
  764. Talmanco (previously Tadalafil Generics)
  765. Drug Safety Update: monthly PDF newsletter: Drug Safety Update July 2021
  766. Medical device cyber security - Consumer information
  767. EU/3/18/1999 - orphan designation for treatment of haemophilia B
  768. European Medicines Agency and FDA announce launch of generic medicines application…
  769. Committee for Herbal Medicinal Products (HMPC): 23-24 November 2015
  770. 21 CFR 1.81: Rejection of entry filing.
  771. Seventh industry stakeholder platform on research and development support
  772. Points to Consider in the Clinical Development of Radiopharmaceuticals for Positron…
  773. Committee for medicinal products for veterinary use: Meeting of 15-17 April 2009
  774. P/0341/2014 - paediatric investigation plan
  775. 12th meeting of the committee for veterinary medicinal products
  776. Clinical trials regulations: transitional arrangements
  777. 21 CFR 868.5340: Nasal oxygen cannula.
  778. Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration
  779. cfr-21-cfr-73-35-astaxanthin21 CFR 73.35: Astaxanthin.
  780. ema-biferonexBiferonex
  781. 21 CFR 892.1610: Diagnostic x-ray beam-limiting device.
  782. Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 January 2017
  783. Public Statement onSifrol, Daquiran, Mirapexin (Pramipexole) - Sudden onset of sleep
  784. ema-rasivalRasival
  785. EMEA-000513-PIP01-08 - paediatric investigation plan
  786. (In Japanese)Basic principles in conducting a validation study of outcome definitions used…
  787. EMEA-001379-PIP01-12-M07 - paediatric investigation plan
  788. ema-medication-errorsMedication errors
  789. Development and data requirements of potency tests for cell-based therapy products and the…
  790. Updated Package Insert PI for empagliflozin Tablets 10mg and 25mg based on company Core…
  791. Guideline on clinical investigation of medicinal products in the treatment of hypertension
  792. Legal authorities of GMP inspections in Japan
  793. FDA warns about rare but serious skin reactions with mental health drug olanzapine…
  794. EMEA-001874-PIP01-15 - paediatric investigation plan
  795. Ecalta - direct healthcare professional communication (DHPC)
  796. Workshop on first-line acute promyelocytic leukaemia treatment: European Union cooperative…
  797. Webinar on regulatory and procedural aspects of applications for type I variations
  798. DR_G.S.R. 917(E) dt_22.12.2009_Amendment in Schedule K_addition of Homeopathic Hair oils
  799. Quality: lifecycle management
  800. EMEA-001825-PIP01-15-M04 - paediatric investigation plan
  801. European Medicines Agency gives recommendations on the use of intravenous nicardipine
  802. New TIR on Infusion Pump Testing Focuses on Clinically Relevant Metrics
  803. EU/3/16/1805 - orphan designation for treatment of soft tissue sarcoma
  804. 21 CFR 70.42: Criteria for evaluating the safety of color additives.
  805. Public Notice regarding the process of regulatory guidance from specific division of CDSCO…
  806. 21 CFR 10.40: Promulgation of regulations for the efficient enforcement of the law.
  807. ema-sibutramine-referralSibutramine - referral
  808. ema-pioglitazone-tevaPioglitazone Teva
  809. QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal…
  810. Suiseng Diff/A - opinion on variation to marketing authorisation
  811. Q&A of Plasma Derived Medicinal Products (PMDPs) [PDF, 31.80 KB]
  812. EU/3/17/1882 - orphan designation for treatment of growth hormone deficiency
  813. Pharmacovigilance-related recommendations to product information for centrally authorised…
  814. Nitrosamine Implementation Oversight Group (NIOG) - Kick-off meeting
  815. 21 CFR 882.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  816. PSUSA/00010283/201501 - periodic safety update report single assessment
  817. Workshop: safe use of medicines during pregnancy and breastfeeding
  818. Committee for Medicinal Products for Human Use (CHMP): 28-30 April 2020
  819. EU/3/07/490 - orphan designation for treatment of non-traumatic osteonecrosis
  820. ema-cardoreg-4mg-referralCardoreg 4mg - referral
  821. PSUSA/00000715/202305 - periodic safety update report single assessment
  822. Clinical investigation of human normal immunoglobulin for subcutaneous and/or…
  823. Chapter 5 - Presentation Guidance Northern Ireland: Chapter 5 - Presentation Guidance - NI
  824. European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) workshop on testing…
  825. Pregabalin IP 75mg + Duloxetine hydrochloride IP eq. to Duloxetine 30mg + Mecobalamin IP…
  826. PSUSA/00001368/201804 - periodic safety update report single assessment
  827. Addendum to the guideline on the evaluation of medicinal products indicated for treatment…
  828. Ginkgo folium - herbal medicinal product
  829. ICH Q8, Q9 and Q10 - questions and answers - Scientific guideline
  830. PSUSA/00000485/202211 - periodic safety update report single assessment
  831. 21 CFR 870.4475: Surgical vessel dilator.
  832. ema-vylaer-spiromaxVylaer Spiromax
  833. ema-zolgensmaZolgensma
  834. PSUSA/00002615/201504 - periodic safety update report single assessment
  835. 21 CFR 872.3360: Preformed cusp.
  836. Pharmacovigilance for advanced therapies
  837. Second industry stakeholder platform on the operation of the centralised procedure for…
  838. ema-topiramate-referralTopiramate - referral
  839. PDF version - 423 KB
  840. EU/3/17/1940 - orphan designation for treatment of haemophilia B
  841. Need for assessment of reproduction toxicity of human insulin analogues - Scientific…
  842. 21 CFR 880.6310: Medical device data system.
  843. ema-workshop-on-neonatesWorkshop on Neonates
  844. UK medicines export and Windsor Framework labelling requirements
  845. Lyophilization of Parenterals
  846. decitabine-tetrahydrouridine
  847. FDA Releases Draft Guidance for Submitting Post-Approval Modifications to Medical Devices…
  848. 21 CFR 866.3820: Treponema pallidum nontreponemal test reagents.
  849. icotrokinra (JNJ-77242113)
  850. Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal…
  851. tga-ectd-withdrawalseCTD withdrawals
  852. cdsco-dec-29-2014-so-3298-eDec 29 2014 SO 3298(E)
  853. Devices made by Silimed: Final update: 22 November 2018
  854. Medical devices for use in relation to COVID-19
  855. EMA review of data on paternal exposure to valproate
  856. Third industry stakeholder platform: operation of European Union pharmacovigilance…
  857. PSUSA/00002849/201811 - periodic safety update report single assessment
  858. ema-clopidogrel-ratiopharmClopidogrel ratiopharm
  859. 21 CFR 73.2775: Manganese violet.
  860. Blood Regulations (SOR/2013-178)
  861. Clinical investigations for electrically powered devices
  862. Information day on the new individual case safety report international standard and ICH…
  863. Public notice of interim decisions on proposed amendments to the Poisons Standard…
  864. Questions and Answers (Q&A) on the “Guidelines for Clinical Evaluation of Drugs for the…
  865. EudraGMP 2.0 gives public access to information about good manufacturing practice (GMP)
  866. Exceptions and modifications to the EU guidance on good pharmacovigilance practices that…
  867. EMEA-003174-PIP02-22 - paediatric investigation plan
  868. PSUSA/00002634/201501 - periodic safety update report single assessment
  869. European Medicines Agency closed 29 August 2016
  870. CDR132L 45.2 (45,2) mg/vial1
  871. STATE NSQ ALERT FOR THE MONTH OF JANUARY-2025
  872. EU/3/16/1810 - orphan designation for treatment of Alström syndrome
  873. Thirty-second meeting of the Management Board
  874. Form MD-12 Specimen proforma for Medical Devices
  875. Submission of notarized/apostilled documents for Import and Registration of cosmetics in…
  876. EMEA-000932-PIP01-10-M02 - paediatric investigation plan
  877. ema-veozaVeoza
  878. EMEA-001094-PIP01-10-M04 - paediatric investigation plan
  879. Faster access to clinical trial information in Europe
  880. November 15, 2016: Science Board to the FDA Meeting Announcement - 11/14/2016
  881. EU/3/18/2084 - orphan designation for treatment of ovarian cancer
  882. Comparable overseas regulators (CORs) for prescription medicines
  883. cdsco-utreglutideUtreglutide
  884. ICH Considerations: general principles to address the risk of inadvertent germline…
  885. PSUSA/00001382/202306 - periodic safety update report single assessment
  886. EMEA-000939-PIP01-10 - paediatric investigation plan
  887. 21 CFR 888.5890: Noninvasive traction component.
  888. (Appendix 9) The Standards for Marketing Approval of Vitamin Preparations
  889. 21 CFR 20.29: Prohibition on withdrawal of records from Food and Drug Administration…
  890. EU/3/15/1565 - orphan designation for treatment of hepatocellular carcinoma
  891. EU/3/12/968 - orphan designation for treatment of pneumonia caused by Staphylococcus…
  892. Imeglimin Hydrochloride Sustained Relase Tablet 1000 mg
  893. PSUSA/00010206/201505 - periodic safety update report single assessment
  894. Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on…
  895. mhra-project-orbisProject Orbis
  896. New treatment for children with type 2 diabetes
  897. EMEA-001730-PIP02-15 - paediatric investigation plan
  898. UPDATED INFORMATION: March 16, 2023: Antimicrobial Drugs Advisory Committee Meeting…
  899. cdsco-imeglimin-tabletsImeglimin tablets
  900. ema-picato-referralPicato - referral
  901. cdsco-bcd-055BCD-055
  902. ema-zulvac-8-ovisZulvac 8 Ovis
  903. Dasatinib Accord Healthcare
  904. ema-zejulaZejula
  905. A Look Ahead: What to Expect in AAMI Standards in 2023
  906. PSUSA/00002925/201805 - periodic safety update report single assessment
  907. ema-fluad-tetraFluad Tetra
  908. KarXT/BMS-986510 Xanomeline+Trospium Chloride
  909. Paediatric Committee (PDCO): 18-21 September 2018
  910. 21 CFR 1.243: Is food registration information available to the public?
  911. Public Notice for feedback on SUGAM Online Portal
  912. Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and…
  913. PSUSA/00010434/201807 - periodic safety update report single assessment
  914. PSUSA/00010484/201905 - periodic safety update report single assessment
  915. UCB Pharma withdraws its marketing authorisation application for Lacosamide Pain UCB…
  916. Committee for Advanced Therapies (CAT): 11-12 November 2010
  917. EMEA-001671-PIP01-14 - paediatric investigation plan
  918. Paediatric Committee (PDCO): 15-17 May 2013
  919. Salmeterol and Fluticasone Propionate - referral
  920. EU/3/24/2903 - orphan designation for treatment of Berardinelli-Seip syndrome (congenital…
  921. cdsco-fs118FS118
  922. Update on somatropin-containing medicines
  923. Human medicines: highlights of 2015
  924. ARGB Appendix 6 - Guidance on TGO 83
  925. ema-abraxaneAbraxane
  926. Common Standards and Specifications on Electromechanical Safety of Medical Devices
  927. Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
  928. PSUSA/00002781/201801 - periodic safety update report single assessment
  929. Nomination form along with family details
  930. Manufacture of the finished dosage form (veterinary) - Scientific guideline
  931. EU/3/21/2501 - orphan designation for treatment of ovarian cancer
  932. Registration opens for workshop on conflicts of interests
  933. Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2023
  934. ema-skycovionSkycovion
  935. PSUSA/00002942/201506 - periodic safety update report single assessment
  936. 21 CFR 882.5070: Bite block.
  937. FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay…
  938. EMEA-001095-PIP02-12 - paediatric investigation plan
  939. New medicine for hereditary rare disease
  940. EMEA-001657-PIP01-14-M01 - paediatric investigation plan
  941. Pantoprazole Sodium IP eq. to Pantoprazole (as gastro-resistant tablet) + Acotiamide…
  942. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18…
  943. EMEA-002485-PIP01-18 - paediatric investigation plan
  944. EU/3/15/1491 - orphan designation for treatment of mucopolysaccharidosis IIIC (Sanfilippo…
  945. CMC Requirements for CTGTP for Clinical Trials and Product Registration
  946. EU/3/15/1569 - orphan designation for treatment of idiopathic hypersomnia
  947. Kenneth Maddock: Building a Foundation for Respect
  948. Regulatory information - Updated variations application form for human and veterinary…
  949. Frangulae cortex - herbal medicinal product
  950. ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data - Scientific…
  951. PSUSA/00001622/202206 - periodic safety update report single assessment
  952. Metformin and metformin-containing medicines - referral
  953. cdsco-imu-131-her2-neuIMU-131 HER2/neu
  954. Steve Campbell: What Did You Say?
  955. cdsco-denosumab-injectionDenosumab Injection
  956. Metformin Hydrochloride IP eq. to Metformin (as extended release form) + Dapagliflozin +…
  957. EMEA-001197-PIP01-11 - paediatric investigation plan
  958. EU/3/19/2187 - orphan designation for treatment of myasthenia gravis
  959. Regulatory information – New tool for companies to facilitate maintenance of information…
  960. Committee for Medicinal Products for Human Use (CHMP): 24-27 February 2025
  961. Pegfilgrastim 6mg/0.6ml subcutaneous injection
  962. 21 CFR 888.3060: Spinal intervertebral body fixation orthosis.
  963. PSUSA/00002843/201804 - periodic safety update report single assessment
  964. Notice for Vaccine Guidelines dated 21 Sept 2020
  965. Measurement of Relative Humidity in the ETO Process
  966. Stability testing of herbal medicinal products and traditional herbal medicinal products…
  967. EMEA-001594-PIP02-13 - paediatric investigation plan
  968. Tech World: Environmental Challenges in Sterile Processing
  969. Review of Corlentor/Procoralan started
  970. September 26, 2019: Meeting of the Pediatric and Drug Safety and Risk Management Advisory…
  971. ema-lupkynisLupkynis
  972. EMEA-001126-PIP01-10-M03 - paediatric investigation plan
  973. EU/3/01/034 - orphan designation for treatment of Wegener's granulomatosis
  974. 21 CFR 830.320: Submission of unique device identification information.
  975. cdsco-bbv154BBV154
  976. EMEA-002598-PIP01-19 - paediatric investigation plan
  977. May 19,2010(G.S.R_426 E)
  978. cdsco-eltrombopagEltrombopag
  979. cdsco-pamrevlumabPamrevlumab
  980. Committee for Herbal Medicinal Products (HMPC): 29-30 May 2017
  981. 21 CFR 884.3900: Vaginal stent.
  982. FAQ on notification for in-house manufacturers of medical devices and in vitro diagnostic…
  983. PSUSA/0001079/201804 - periodic safety update report single assessment
  984. EMEA-002224-PIP01-17 - paediatric investigation plan
  985. Names of liposomal medicines to be changed to avoid medication errors
  986. Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs
  987. 21 CFR 880.2500: Spinal fluid manometer.
  988. 2021.04.07_S.O. 1520(E)_Notification of Raghuram Reddy Adidala, CDTL Hyderabad
  989. ema-nexium-controlNexium Control
  990. Mary Ann Drosnock: New Sterile Processing TIR Will Help Reduce Confusion
  991. EU/3/17/1833 - orphan designation for treatment of plasma cell myeloma
  992. Ciprofloxacin Hikma - referral
  993. Febuxostat Viatris (previously Febuxostat Mylan)
  994. PSUSA/00003161/201808 - periodic safety update report single assessment
  995. New online platform for scientific advice

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