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Global regulations and guidance

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

  1. Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG)
  2. Pembrolizumab Concentrate for Solution for Infusion 100 mg /4 mL Vial (25 mg/mL)
  3. 21 CFR 812.5: Labeling of investigational devices.
  4. 21 CFR 868.5580: Oxygen mask.
  5. Workshop on biosimilars takes place today
  6. RabiesHumanMonoclonalAntibody
  7. EU/3/20/2375 - orphan designation for treatment of Duchenne muscular dystrophy
  8. cdsco-august-4-2016-so2612-eAugust 4 2016 SO2612(E)
  9. Committee for Advanced Therapies (CAT): 11-12 August 2011
  10. GL-08-R2 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2025 Sep) PUB
  11. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 September 2019
  12. ema-rotashieldRotashield
  13. cdsco-pmz-1620PMZ-1620
  14. How EMA evaluates medicines for human use
  15. 21 CFR 1.904: What definitions apply to this subpart?
  16. PSUSA/00010693/202110 - periodic safety update report single assessment
  17. Adaptive pathways workshop
  18. Refusal of orphan designation for treatment of cystic fibrosis
  19. cdsco-octefibrinOctefibrin
  20. PSUSA/00002828/201604 - periodic safety update report single assessment
  21. Sutezolid, TBI-223, Pretomanid, Linezolid, Bedaquiline, Isoniazid, Rifampicin…
  22. EMEA-002649-PIP01-19 - paediatric investigation plan
  23. RESOLUTION RDC NO. 15, 28 MARCH 2014
  24. EMEA-002095-PIP01-16-M01 - paediatric investigation plan
  25. ema-solumarvSolumarv
  26. Coronavirus vaccine (rDNA) – BBV151
  27. Liposomal amphotericin B product-specific bioequivalence guidance
  28. Safety trial finds risk of blood clots in the lungs and death with higher dose of…
  29. NMPA Issued 3 Guidelines for Technical Review of the Registration of Synthetic Resin Teeth…
  30. Call to pool research resources into large multi-centre, multi-arm clinical trials to…
  31. ema-arti-cell-forteArti-Cell Forte
  32. Need for maximum residue limit (MRL) evaluation for biological substances - Scientific…
  33. Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 July 2021
  34. EMEA-002366-PIP01-18 - paediatric investigation plan
  35. ema-pregabalin-mylan-pharmaPregabalin Mylan Pharma
  36. EMEA-000184-PIP01-08-M02 - paediatric investigation plan
  37. PSUSA/00010245/201703 - periodic safety update report single assessment
  38. VICH GL34 Biologicals: testing for the detection of Mycoplasma contamination - Scientific…
  39. Drug Alert list for month of June 2013
  40. 21 CFR 822.10: What must I include in my surveillance plan?
  41. cdsco-vericiguat-therapyVericiguat therapy
  42. International Cooperation on Harmonisation of Technical Requirements for Registration of…
  43. AAMI Releases Special Report on Artificial Intelligence
  44. HSA Guidelines on Good Manufacturing Practice for CTGTP
  45. EU/3/21/2416 - orphan designation for treatment of glioma
  46. PSUSA/00001535/201901 - periodic safety update report single assessment
  47. Register Now for inaugural AAMI eXchange Golf Tournament
  48. Increased fees coming into effect on 1 April 2012
  49. “Make Your Medical Device Pitch For Kids!” and MedTech Color Competitions Announce…
  50. Inspection Strategy for Canada's Access to Medicines Regime (POL-0055)
  51. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
  52. EMEA-001904-PIP02-17 - paediatric investigation plan
  53. EU/3/06/427 - orphan designation for treatment of soft tissue sarcoma
  54. 21 CFR 862.1095: Ascorbic acid test system.
  55. PSUSA/00002096/201703 - periodic safety update report single assessment
  56. EU/3/20/2395 - orphan designation for treatment of amyotrophic lateral sclerosis
  57. Surrender and Cancellation of Cosmetics Registration Certificate No. RC/COS-003067 dated…
  58. EMEA-000828-PIP01-09-M09 - paediatric investigation plan
  59. FDA Seeks Comments on Planned Transition from Emergency Use Authorizations
  60. DR_G.S.R. 499(E) dt_17.07.2019_Consesquential amendments to GSR 1337(E) Dt. 27.10.2017
  61. Annual HTM Survey Hints at Rising Salaries and ‘Southern Boom’
  62. ema-ebolaEbola
  63. Committee for Orphan Medicinal Products elects new chair and vice-chair
  64. ema-kaletraKaletra
  65. Ulipristal acetate - paediatric investigation plan
  66. Medical Device Standards and Specifications
  67. DOR BIOPHARMA UK Ltd withdraws marketing authorisation application for orBec…
  68. Lansoprazol CT-Arzneimittel 15 mg and 30 mg - referral
  69. ema-repaglinide-accordRepaglinide Accord
  70. 21 CFR 870.4280: Cardiopulmonary prebypass filter.
  71. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 July 2014
  72. Osseor - withdrawal of application for variation to marketing authorisation
  73. Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities…
  74. PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya…
  75. cancellation order dated 24.08.2026 (Skintle Enterprises Pvt Ltd)
  76. EMEA Workshop on Neonates: Development of medicines for neonates needs multi disciplinary…
  77. 21 CFR 866.3375: Mycoplasma spp. serological reagents.
  78. Committee for Orphan Medicinal Products: January 2007 meeting
  79. PSUSA/00002500/202003 - periodic safety update report single assessment
  80. All herbal documents under consultation
  81. Union Pharmacovigilance Database: follow up webinar on collection and recording of…
  82. Bisphosphonates: use and safety
  83. 21 CFR 868.5130: Anesthesia conduction filter.
  84. EU/3/18/2089 - orphan designation for treatment of Duchenne muscular dystrophy
  85. New medicine to treat infections in adults
  86. PRAC recommends new measures to avoid valproate exposure in pregnancy
  87. Guideline for Clinical Evaluation of Antibacterial Drugs
  88. Notice regarding 32 meeting of the Apex Committee held on 03.11.2016
  89. ema-masivieraMasiviera
  90. Typhoid Conjugate vaccine
  91. 2026.04.10_G.S.R. 269(E)_Draft Notification to amend certain provisions w.r.t. Medical…
  92. 21 CFR 1.362: What records are excluded from this subpart?
  93. 2024.03.28_S.O. 1577(E)_implementation of Jan Vishwas (Amendment of Provisions) Act, 2023…
  94. Strict regulatory actions to prevent illegal manufacturing, sale, distribution and import…
  95. 21 CFR 73.1001: Diluents in color additive mixtures for drug use exempt from…
  96. EU/3/17/1872 - orphan designation for treatment of cutaneous T-cell lymphoma
  97. Benzathine benzylpenicillin intended for administration to food-producing species…
  98. EU/3/05/267 - orphan designation for treatment of malignant gastrointestinal stromal…
  99. Documents to Be Attached to Applications for Accreditation of Foreign Manufacturers of…
  100. 21 CFR 822.36: Can you inspect and copy the records related to my postmarket surveillance…
  101. COVID-19: Personal protective equipment 3D printing and manufacturing
  102. EU/3/15/1576 - orphan designation for treatment of ovarian cancer
  103. How to Find the Clinical AI in Your Facility and Govern It
  104. Recombinant Insulin Aspart Injection I.P (r-DNA origin) 100U/ml or 3.5 mg/ml of Insulin…
  105. Q&A on the Master File (MF) System, Part V
  106. ema-verafloxVeraflox
  107. ema-mirapexinMirapexin
  108. EMEA-002533-PIP01-18 - paediatric investigation plan
  109. 21 CFR 21.75: Rights of legal guardians.
  110. EMEA-000252-PIP01-08 - paediatric investigation plan
  111. Committee for Medicinal Products for Veterinary Use (CVMP): 2-4 June 2015
  112. Committee for Orphan Medicinal Products (COMP): 10-11 December 2013
  113. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30…
  114. Declaration of herbal substances and herbal preparations in herbal medicinal…
  115. Naftifine hydrochloride cream 2% b
  116. ema-miglustat-gen-orphMiglustat Gen.Orph
  117. Nodetrip (previously Xeristar)
  118. Who Supports the AAMI Foundation? Meet Andy Ulvenes of Renovo Solutions
  119. Paediatric Committee (PDCO): 14-16 January 2015
  120. EMEA-001461-PIP01-13 - paediatric investigation plan
  121. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March…
  122. EMEA-001514-PIP01-13-M01 - paediatric investigation plan
  123. 21 CFR 862.1640: Protein-bound iodine test system.
  124. SME info day on the new clinical trial regulation
  125. Eighth industry stakeholder platform: operation of the European Union (EU)…
  126. Live recombinant vector vaccines for veterinary use - Scientific guideline
  127. 21 CFR 870.4885: External vein stripper.
  128. DR_G.S.R. 900(E) dt_12.12.2001_Form 45 and others
  129. 21 CFR 870.1360: Trace microsphere.
  130. International coordination needed to encourage conduct of large, decision-relevant…
  131. ema-cimziaCimzia
  132. Software for use with COVID-19 rapid antigen self-tests
  133. EMEA-002824-PIP01-20 - paediatric investigation plan
  134. Trastuzumab Deruxtecan (T-DXd)
  135. EMEA-001060-PIP01-10 - paediatric investigation plan
  136. EMEA-000084-PIP02-10 - paediatric investigation plan
  137. Public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU
  138. EU/3/21/2505 - orphan designation for treatment of mucopolysaccharidosis type I
  139. 21 CFR 892.1860: Radiographic film/cassette changer.
  140. Nuvolo Extends its Sponsorship of AAMI’s BMET Apprenticeship Certification Program
  141. Resflor solution injectable and associated names - referral
  142. EMA Management Board: highlights of October 2015 meeting
  143. EU/3/07/435 - orphan designation for prevention of delayed graft function after solid…
  144. EMEA-002397-PIP01-18-M03 - paediatric investigation plan
  145. EMEA-002627-PIP01-19 - paediatric investigation plan
  146. EMEA-001701-PIP01-14-M02 - paediatric investigation plan
  147. Reporting adverse incidents: neurostimulators
  148. EU/3/08/595 - orphan designation for treatment of peripheral T-cell lymphoma
  149. Reflection papers on regulatory requirements for the development of medicinal products for…
  150. PSUSA/00002181/202101 - periodic safety update report single assessment
  151. Global regulators work towards alignment on policy approaches and regulatory flexibility…
  152. DR_G.S.R. 611(E) dt_31.07.2015_Amendment SchY_Relating to Informed Consent
  153. PSUSA/00010735/201910 - periodic safety update report single assessment
  154. First vaccine to protect adults from Chikungunya
  155. Infection Prevention Is Important Everywhere! A Conversation with APIC
  156. Committee for Medicinal Products for Human Use (CHMP): 15-18 February 2010
  157. Actions to support the development of medicines for children
  158. EMEA-000216-PIP01-08 - paediatric investigation plan
  159. EMEA-002559-PIP08-23 - paediatric investigation plan
  160. Hurricane Recovery and Repairing the IV Supply Chain
  161. Follicle Stimulating Hormone (Human Recombinant)
  162. Committee for Medicinal Products for Human Use (CHMP): 28-31 May 2018
  163. Filgrastim 300mcg/0.5ml
  164. ema-zoledronic-acid-accordZoledronic Acid Accord
  165. Doxazosin "Winthrop" 4mg - referral
  166. PSUSA/00009190/202101 - periodic safety update report single assessment
  167. EU/3/23/2754 - orphan designation for treatment of Huntington's disease
  168. European Medicines Agency recommends authorisation of novel antibiotic agent
  169. Carboplatin and Paclitaxel
  170. ema-zinnat-referralZinnat - referral
  171. Paediatric Committee (PDCO): 3-6 September 2024
  172. PSUSA/00000131/201909 - periodic safety update report single assessment
  173. Senate Bill Illuminates Future of Cyber Enforcement
  174. Draft Guidelines on Good Distribution Practices for Pharmaceutical Products
  175. 21 CFR 864.7320: Fibrinogen/fibrin degradation products assay.
  176. DR_G.S.R. 658(E) dt_31.08.1994_Amendment to First Schedule_Substitution Book name
  177. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 June 2014
  178. cdsco-bcg-vaccineBCG vaccine
  179. Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated…
  180. Guidance Document for Export NOC
  181. ema-giotrifGiotrif
  182. First AAMI eXchange Keynote Highlights the Power of Positive Reinforcement
  183. Tips from Cybersecurity Visionary Kevin Fu
  184. Montelukast IP + Fexofenadine Hydrochloride IP suspension (Phase III)
  185. Notification of intent to import an unlicensed medicinal product
  186. Common issues identified during clinical trial applications: Common issues: Clinical
  187. 21 CFR 890.5670: Internal therapeutic massager.
  188. Individual case safety report information day
  189. Committee for Advanced Therapies (CAT): 15-17 March 2017
  190. AAMI Foundation Offers 10 Scholarships in 10th Year of Program
  191. cdsco-ofatumumab-safetyOfatumumab safety
  192. EMEA-001305-PIP01-12 - paediatric investigation plan
  193. Identification of medicines: EU task force to implement new international standards
  194. Declaration of Conformity
  195. April 12, 2016: Pediatric Advisory Committee Meeting Announcement - 04/12/2016
  196. Month wise Tentative schedule of SEC (Vaccine) meetings of the year 2021
  197. Authenticity verification for electronic certificates
  198. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13…
  199. World Arthritis Day: 12 October 2012
  200. IT systems unavailable from 30 October to 3 November 2015
  201. Origani majoranae herba - herbal medicinal product
  202. NMPA Announcement on Revising the Package Insert of Methimazole Preparations
  203. Rubraca - direct healthcare professional communication (DHPC)
  204. PSUSA/00000599/201812 - periodic safety update report single assessment
  205. PSUSA/00010468/202201 - periodic safety update report single assessment
  206. EU/3/17/1874 - orphan designation for treatment of haemophilia A
  207. S.O. 1352(E) dated 23.03.2018_G.S.R. 1074(E) dated 30.10.2018
  208. 21 CFR 876.5320: Nonimplanted electrical continence device.
  209. ema-menitorix-referralMenitorix - referral
  210. 21 CFR 866.3960: Nucleic acid-based device for the amplification, detection, and…
  211. Variations to Marketing Authorisations (MAs)
  212. EU/3/06/416 - orphan designation for treatment of acute myeloid leukaemia
  213. Non-clinical and clinical development of similar biological medicinal products containing…
  214. EU/3/21/2408 - orphan designation for treatment of retinitis pigmentosa
  215. AAMI TIR99, 2024: Handy Reprocessing Insights for Ultrasound Probes & Dilators
  216. 21 CFR 14.29: Conduct of a hearing before an advisory committee.
  217. ema-xelodaXeloda
  218. Barbara Maguire: The Many Values of CBET Certification
  219. Best practice in the labelling and packaging of medicines
  220. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27…
  221. Bioactive concentrate from small marine fish + water for injection (WFI) solution for…
  222. EU/3/14/1416 - orphan designation for treatment of neuroblastoma
  223. Revefenacin Inhalation Solution 175 mcg/3ml
  224. EU/3/18/2037 - orphan designation for treatment of Friedreich’s ataxia
  225. 21 CFR 888.3570: Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
  226. Frontpro (previously known as Afoxolaner Merial)
  227. cdsco-baricitinib-eli-lilyBaricitinib eli lily
  228. PSUSA/00000696/202311 - periodic safety update report single assessment
  229. cdsco-brolucizumabBrolucizumab
  230. PSUSA/00010224/201502 - periodic safety update report single assessment
  231. Michele DeMeo: Why Professional Conferences Matter
  232. ema-zulvac-1-ovisZulvac 1 Ovis
  233. Pseudoephedrine - direct healthcare professional communication (DHPC)
  234. ema-neocoliporNeocolipor
  235. Nineteenth Meeting of the Management Board
  236. 21 CFR 872.3570: OTC denture repair kit.
  237. EMEA-002358-PIP03-19 - paediatric investigation plan
  238. ema-cystadropsCystadrops
  239. EMEA-002751-PIP02-22 - paediatric investigation plan
  240. Osimertinib in Combination with Savolitinib
  241. Electronic Common Technical Document (eCTD) submissions update
  242. 21 CFR 870.5325: Defibrillator tester.
  243. EU/3/07/451 - orphan designation for treatment of pancreatic cancer
  244. Dapivirine Vaginal Ring 25 mg
  245. EMA business hours over Ascension Day holidays, 26 and 27 May
  246. Notice-dated 12.10.2012: Directions issued under Section 33P of D & C Act 1940.
  247. Management Board meeting: 11 March 2021
  248. First medicine to treat neonatal diabetes
  249. 21 CFR 1.671: How will FDA review my application for direct accreditation or renewal of…
  250. 21 CFR 830.360: Records to be maintained by the labeler.
  251. DR_G.S.R. 752(E) dt_12.10.2011_Suspension of Letrozole for induction of Ovulation
  252. 21 CFR 1.1124: What are the records requirements for a recognized accreditation body?
  253. Inhalation and nasal spray registered medicines
  254. Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2021
  255. EMEA-002999-PIP01-21 - paediatric investigation plan
  256. 21 CFR 864.7675: Leukocyte peroxidase test.
  257. Document and information management procedures
  258. Mike Ahmadi: When It Comes to Cybersecurity, the Regulatory Will Is Weak
  259. PSUSA/00002067/201510 - periodic safety update report single assessment
  260. PSUSA/00000059/201709 - periodic safety update report single assessment
  261. EMEA-000347-PIP02-16-M05 - paediatric investigation plan
  262. PSUSA/00002307/201806 - periodic safety update report single assessment
  263. Alfuzosin Hydrochloride IP (extended release form) Tadalafil IP film coated tablets (Phase…
  264. ema-rss-feedsRSS feeds
  265. EU/3/09/614 - orphan designation for treatment of hypercortisolism (Cushing's syndrome) of…
  266. Ziltivekimab C 30 mg/ml / placebo
  267. Non-Clinical and New Approach Methodologies European Specialised Expert Community
  268. QMS P0002.006: Document Control Approval Procedure
  269. ema-ms-h-vaccineMS-H Vaccine
  270. Partial Revision of "Re-Examination Period of Prescription Drugs"
  271. Change Notification applications arising from the EU MDR/IVDR related changes to…
  272. Safety and residue data requirements for applications for non-immunological veterinary…
  273. EU/3/06/363 - orphan designation for treatment of glioma
  274. Development of live attenuated influenza vaccines
  275. EMEA-002779-PIP01-20 - paediatric investigation plan
  276. Questions and Answers (Q&A) on the Application for Confirmation of Change Plans for…
  277. Veterinary medicinal products controlling Varroa destructor parasitosis in bees…
  278. 21 CFR 884.1710: Closed loop hysteroscopic insufflator with cutter-coagulator.
  279. EMEA-002796-PIP01-20-M01 - paediatric investigation plan
  280. EU/3/08/574 - orphan designation for treatment of spinal cord injury
  281. 21 CFR 868.5870: Nonrebreathing valve.
  282. ICH M5 EWG Units and measurements controlled vocabulary - Scientific guideline
  283. EMEA-001832-PIP01-15-M02 - paediatric investigation plan
  284. (Appendix 4) The Standards for Marketing Approval of Oral Remedies for Rhinitis
  285. Workshop on the clinical investigation of new medicines for the treatment of multiple…
  286. EMEA-001541-PIP01-13 - paediatric investigation plan
  287. Alpelisib plus Fulvestrant
  288. Paediatrics: Regulatory and procedural guidance
  289. 21 CFR 890.3025: Prosthetic and orthotic accessory.
  290. Data requirements for multi-strain dossiers for inactivated veterinary vaccines…
  291. EMEA-002761-PIP01-20 - paediatric investigation plan
  292. ema-bovilis-blue-8Bovilis Blue-8
  293. Adaptogenic concept - Scientific guideline
  294. EMEA-002698-PIP03-22 - paediatric investigation plan
  295. EMEA-001782-PIP01-15-M03 - paediatric investigation plan
  296. Paediatric Committee (PDCO): 10-12 August 2011
  297. Committee for Orphan Medicinal Products (COMP): 15-17 May 2023
  298. PSUSA/00010155/201609 - periodic safety update report single assessment
  299. PSUSA/00009284/202302 - periodic safety update report single assessment
  300. EU/3/19/2149 - orphan designation for treatment of Huntington’s disease
  301. 21 CFR 54.6: Recordkeeping and record retention.
  302. EMEA-002662-PIP01-19 - paediatric investigation plan
  303. 21 CFR 870.3450: Vascular graft prosthesis.
  304. Transferring an orphan designation
  305. PSUSA/00002319/202212 - periodic safety update report single assessment
  306. Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal…
  307. EU/3/13/1202 - orphan designation for treatment of hepatocellular carcinoma
  308. Career Center: Six Steps for Strategic Planning
  309. cdsco-lou064-remibrutinibLOU064 (Remibrutinib)
  310. EMEA-000788-PIP02-11-M11 - paediatric investigation plan
  311. Quality, non-clinical and clinical issues relating specifically to recombinant…
  312. European Medicines Agency adopts a positive opinion for the use of Prozac in the treatment…
  313. ema-zafirideZafiride
  314. Healthcare Professionals' Working Group (HCPWG)
  315. EU/3/01/028 - orphan designation for treatment of graft-versus-host disease
  316. EMEA-000058-PIP01-07 - paediatric investigation plan
  317. 21 CFR 880.6250: Non-powdered patient examination glove.
  318. Responding to emerging health threats in the EU
  319. EMA closed 30-31 May 2019
  320. cfr-21-cfr-870-1-scope21 CFR 870.1: Scope.
  321. EU/3/20/2289 - orphan designation for treatment of bullous pemphigoid
  322. ema-ciclosporin-idl-referralCiclosporin IDL - referral
  323. EMEA-001887-PIP01-15 - paediatric investigation plan
  324. Considerations for the Clinical Evaluation of Blood Coagulation Factor VIII and Factor IX…
  325. PSUSA/00010271/201707 - periodic safety update report single assessment
  326. EU/3/22/2599 - orphan designation for treatment of uveal melanoma
  327. cdsco-imatinib-mesylateimatinib mesylate
  328. EU/3/05/316 - orphan designation for treatment of pulmonary arterial hypertension and…
  329. EU/3/18/2034 - orphan designation for treatment of neurodegeneration with brain iron…
  330. Non-clinical Working Party documents
  331. cdsco-everolimus-aloneEverolimus alone
  332. 21 CFR 892.1540: Nonfetal ultrasonic monitor.
  333. European Medicines Agency recommends new contraindication for Velcade (bortezomib)
  334. 21 CFR 1.1370: What must be included in a petition requesting modified requirements or an…
  335. 21 CFR 878.4493: Absorbable poly(glycolide/l-lactide) surgical suture.
  336. PSUSA/00000559/201901 - periodic safety update report single assessment
  337. EMEA-001208-PIP01-11-M03 - paediatric investigation plan
  338. OTC medicine monograph: Aspirin tablets for oral use
  339. Drugs Alert for the month of March 2015
  340. PSUSA/00000303/202303 - periodic safety update report single assessment
  341. 2024.02.02_DR_G.S.R. 91(E)_ Notification of Government Analysts for NIB Noida
  342. PSUSA/00010442/202101 - periodic safety update report single assessment
  343. ema-azacitidine-mylanAzacitidine Mylan
  344. EMEA-000804-PIP01-09-M02 - paediatric investigation plan
  345. Public Notice regarding DCGI meeting with Stakeholders Dated 15.04.2024 for 18 April 2024…
  346. EMEA-002369-PIP01-18-M02 - paediatric investigation plan
  347. Alan Lipschultz: Representing HTM in China’s ‘City of Flowers’
  348. Inactivated Influenza Vaccine (Split Virion) I.P. (Tetravalent) [VaxiFluTM-4] + LiteVax…
  349. 21 CFR 866.5430: Beta-2-glycoprotein I immunological test system.
  350. Update to Ongoing Safety Review of GnRH Agonists and Notification to Manufacturers of GnRH…
  351. FDA warns about serious heart problems with high doses of the antidiarrheal medicine…
  352. EU/3/16/1610 - orphan designation for treatment of acute myeloid leukaemia
  353. EMEA-001474-PIP02-16-M02 - paediatric investigation plan
  354. EMEA-002691-PIP01-19 - paediatric investigation plan
  355. EU/3/14/1266 - orphan designation for treatment of B-lymphoblastic leukaemia/lymphoma
  356. EMEA-000912-PIP01-10-M06 - paediatric investigation plan
  357. PSUSA/00010461/202109 - periodic safety update report single assessment
  358. EU/3/22/2655 - orphan designation for treatment of small cell lung cancer
  359. Vildagliptin / Metformin hydrochloride Accord
  360. Glycopyrronium IP eq. to Glycopyrronium 50mcg + Fluticasone Furoate Ph. Eur. 100mcg +…
  361. cdsco-efgartigimod-ph20-scEfgartigimod PH20 SC
  362. 21 CFR 801.410: Use of impact-resistant lenses in eyeglasses and sunglasses.
  363. Medical Devices (Registration) Regulations 2021 (SI 691/2021) [General]
  364. European network of paediatric research at the European Medicines Agency (Enpr-EMA)…
  365. EMA confirms measures to minimise risk of serious side effects with Janus kinase…
  366. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020
  367. Tegoprazan Tablets 50 mg
  368. Criteria to be considered for the evaluation of new active substance (NAS) status of…
  369. ema-desloratadine-krkaDesloratadine Krka
  370. EU/3/22/2679 - orphan designation for treatment of graft-versus-host-disease
  371. Core summary of product characteristics (SmPC) and package leaflet for fluorodopa (18F)…
  372. ICH Q5C Stability testing of biotechnological/biological products - Scientific guideline
  373. EU/3/07/440 - orphan designation for treatment of congenital alpha-1 antitrypsin…
  374. ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies…
  375. Lumeblue (previously known as Methylthioninium chloride Cosmo)
  376. VICH GL14 Efficacy of anthelmintics: specific requirements for caprines - Scientific…
  377. 21 CFR 876.5860: High permeability hemodialysis system.
  378. EMA annual report 2018 published
  379. EU/3/14/1379 - orphan designation for treatment of malignant hyperthermia
  380. ema-uU
  381. EMEA-002040-PIP01-16 - paediatric investigation plan
  382. Overview of the Assessment Program Flowchart
  383. DR_G.S.R. 328(E) dt_03.04.2017_Rule 122P_Blood banks and Blood Donation Camps
  384. Committee for Advanced Therapies (CAT): 4-6 December 2024
  385. EU/3/08/559 - orphan designation for treatment of idiopathic pulmonary fibrosis
  386. EU/3/16/1758 - orphan designation for treatment of acute myeloid leukaemia
  387. AAMI Looks to Extend Mission to Dental Field
  388. Authorised Prescriber Scheme
  389. 21 CFR 888.3230: Finger joint polymer constrained prosthesis.
  390. PSUSA/00010239/201602 - periodic safety update report single assessment
  391. ema-edistrideEdistride
  392. PSUSA/00001211/202303 - periodic safety update report single assessment
  393. EMEA-001373-PIP01-12-M04 - paediatric investigation plan
  394. Medical devices: software applications (apps): Appendix 4 - Field Safety Warnings and…
  395. What’s New in Vaporized Hydrogen Peroxide Sterilization? Overview of Existing and Future…
  396. EMEA recommends information on lung cancer cases to be included inExubera product…
  397. Alert on theft of multiple drug products of M/s. Novo Nordisk during transit
  398. EU/3/13/1218 - orphan designation for prevention of arteriovenous access dysfunction in…
  399. 21 CFR 866.5400: Alpha-globulin immunological test system.
  400. EMA publishes comments on Member States' hosting bids
  401. PSUSA/00001392/202108 - periodic safety update report single assessment
  402. 21 CFR 870.1800: Withdrawal-infusion pump.
  403. EMEA-002757-PIP01-19 - paediatric investigation plan
  404. Drug Alert list for month of December 2021
  405. New pilot programme to support orphan medical devices
  406. Anti-COVID19 Serum [Equine Anti Covid Antibody Fragments F(ab’)2]
  407. European Union (Clinical Trials on Medicinal Products for Human Use) (National Research…
  408. PSUSA/00010155/201909 - periodic safety update report single assessment
  409. Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
  410. Sixth workshop for micro, small and medium-sized enterprises (SMEs) - Focus on scientific…
  411. Allogeneic ex vivo expanded umbilical cord blood cells - paediatric investigation plan
  412. 21 CFR 864.7735: Prothrombin-proconvertin test and thrombotest.
  413. 21 CFR 58.10: Applicability to studies performed under grants and contracts.
  414. Zofran (ondansetron) - Abnormal heart rhythms may be associated with use of Zofran…
  415. Is diclofenac a threat to European vultures?
  416. 2nd EMEA Workshop on Orphan Medicinal Products for patients' representatives and learned…
  417. Check List for 30-day-Clinical Trial Notification Review on an Initial Clinical Trial…
  418. EMEA-001207-PIP01-11-M01 - paediatric investigation plan
  419. Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 September 2023
  420. EU/3/24/2929 - orphan designation for treatment of complex regional pain syndrome
  421. An “American Dream” in Healthcare Technology Management
  422. Tripartite meeting held between the EMA, Food and Drug Administration (FDA) and…
  423. EU/3/20/2281 - orphan designation for treatment of paroxysmal nocturnal haemoglobinuria
  424. PSUSA/00010285/201507 - periodic safety update report single assessment
  425. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting
  426. PSUSA/00001711/202007 - periodic safety update report single assessment
  427. DR_G.S.R. 521(E) dt_01.06.2018_Form12B_Extended validity of personal import licence
  428. European Medicines Agency workshop on the clinical investigation of medicines for the…
  429. Workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK)…
  430. EU/3/06/398 - orphan designation for treatment of myasthenia gravis
  431. Committee for Advanced Therapies (CAT): 12-13 January 2012
  432. EMEA-003296-PIP01-22 - paediatric investigation plan
  433. Guideline on the scientific application and the practical arrangements necessary to…
  434. EMEA-001545-PIP01-13-M02 - paediatric investigation plan
  435. Standardizing Packaging for ALL KINDS of Sterile Device Transportation
  436. General Office of the State Council Issued the Opinions on Establishing a Team of…
  437. Amendment of the Enforcement Regulations of the Act on Securing Quality, Efficacy and…
  438. ema-cresembaCresemba
  439. LinkedIn Live interview with Peter Arlett: Real-world evidence in medicines regulation
  440. ema-sumatriptan-galpharmSumatriptan Galpharm
  441. Deferasirox Formulation(Granules)
  442. Paediatric Committee (PDCO): 17-19 August 2016
  443. ema-gvk-biosciences-referralGVK Biosciences - referral
  444. EU/3/14/1367 - orphan designation for treatment of hereditary haemorrhagic telangiectasia
  445. Metacam - opinion on variation to marketing authorisation
  446. Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2017
  447. ema-starlixStarlix
  448. EU/3/04/226 - orphan designation for treatment of renal-cell carcinoma
  449. EMEA-002692-PIP01-19 - paediatric investigation plan
  450. PSUSA/0000958/201409 - periodic safety update report single assessment
  451. Saroten and associated names - referral
  452. EMA Paediatric Committee elects Brian Aylward as its new Chair
  453. 21 CFR 862.1475: Lipoprotein test system.
  454. EMEA-000384-PIP01-08 - paediatric investigation plan
  455. Latter to All state/UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs…
  456. NMPA Issued the Guidelines for Conditional Approval for Marketing of Medical Devices
  457. EMEA-002856-PIP01-20 - paediatric investigation plan
  458. Venous Self-Expanding Stent System Receives FDA Approval
  459. EMEA-002461-PIP01-18 - paediatric investigation plan
  460. CardioGen-82 - Increased radiation exposure due to undetected strontium breakthrough when…
  461. EU/3/22/2618 - orphan designation for treatment of amyotrophic lateral sclerosis
  462. European Union (National Research Ethics Committee for Clinical Investigations of Medical…
  463. EMA guidance supports development of new antibiotics
  464. cdsco-crizotinibCRIZOTINIB
  465. cdsco-empagliflozin-10mgEmpagliflozin 10mg
  466. Update on ongoing European review of pioglitazone–containing medicines
  467. Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2017
  468. EMEA-001894-PIP01-15-M01 - paediatric investigation plan
  469. Towards a permanent collaboration framework for EMA and Health Technology Assessment…
  470. European Medicines Agency workshop with European Union pharmaceutical industry…
  471. Pharmacovigilance Risk Assessment Committee (PRAC) elects chair and vice-chair
  472. Good Laboratory Practice (Nonclinical Laboratories)
  473. ema-voxzogoVoxzogo
  474. cdsco-dabigatran-etexilateDabigatran Etexilate
  475. EMEA-000973-PIP01-10-M04 - paediatric investigation plan
  476. AAMI Foundation Names Six Scholarship Recipients
  477. Details of Importers whose permissions have been suspended / cancelled 2024
  478. Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and…
  479. In Vivo Bioavailability-Bioequivalence Studies - Analytical
  480. ema-gonazonGonazon
  481. ema-stelfontaStelfonta
  482. March 21, 2024: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting…
  483. Interpretation of the NMPA Announcement on Further Adjustment and Optimization of Matters…
  484. Committee for Advanced Therapies (CAT): 18-20 May 2016
  485. EU/3/12/999 - orphan designation for treatment of cytomegalovirus disease in patients with…
  486. Here's How the FDA Is Reducing Time to Process Device Submissions
  487. 21 CFR 880.5240: Medical adhesive tape and adhesive bandage.
  488. 21 CFR 872.2060: Jaw tracking device.
  489. PSUSA/00003004/201902 - periodic safety update report single assessment
  490. ema-didanosine-referralDidanosine - referral
  491. Doxazosin Retard "Arrow" 4 mg - referral
  492. PSUSA/00010376/201510 - periodic safety update report single assessment
  493. ema-herzumaHerzuma
  494. cdsco-ql1205-versus-lucentisQL1205 Versus Lucentis
  495. cdsco-noticeNotice
  496. Joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop takes place today
  497. Guideline on clinical investigation of medicinal products for the treatment of chronic…
  498. EU/3/12/1087 - orphan designation for treatment of growth hormone deficiency
  499. Workshop on generation and use of Health Based Exposure Limits (HBEL)
  500. ema-mulsevoMulsevo
  501. ARCHIVED - How to Submit a Trade Complaint
  502. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 1…
  503. EMEA-001777-PIP01-15 - paediatric investigation plan
  504. Avandia - Avandia (rosiglitazone) labels now contain updated information about…
  505. Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs
  506. NMPA Issued the Announcement on Implementing Work Specifications for Cosmetics…
  507. 21 CFR 10.33: Administrative reconsideration of action.
  508. Budesonide IP + Formoterol Fumarate IP + Glycopyrronium Ph. Eur inhalation powder (Phase…
  509. Levodopa/carbidopa/entacapone product-specific bioequivalence guidance
  510. Handling of Situations requiring submission of “Documents related to Clinical Study…
  511. EMEA- 002191-PIP02-17 - paediatric investigation plan
  512. EMEA-002172-PIP02-17-M02 - paediatric investigation plan
  513. 21 CFR 872.3300: Hydrophilic resin coating for dentures.
  514. Fifth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical…
  515. Duloxetine Boehringer Ingelheim
  516. Stolen Covidien Surgical Stapler Reloads: FDA Safety Communication
  517. ema-brimica-genuairBrimica Genuair
  518. EMEA-001834-PIP02-16-M01 - paediatric investigation plan
  519. Paediatric strategy forum for medicinal product development for epigenetic modifiers in…
  520. EMEA-001649-PIP02-21 - paediatric investigation plan
  521. EU/3/08/548 - orphan designation for treatment of multiple myeloma
  522. DR_G.S.R. 640(E) dt_29.06.2016_Sch MIII(Rule 69, 69A,75,75A,76)_Quality management system…
  523. EMA getting ready for the publication of clinical data
  524. PSUSA/00001744/201703 - periodic safety update report single assessment
  525. FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has…
  526. Committee for Medicinal Products for Human Use (CHMP): 19-22 June 2017
  527. EMEA-001872-PIP01-15-M02 - paediatric investigation plan
  528. EMEA-000627-PIP01-09-M04 - paediatric investigation plan
  529. EU/3/02/087 - orphan designation for treatment of familial adenomatous polyposis (FAP)
  530. ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions…
  531. Guidance Policy - Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research…
  532. Center for Drug Evaluation of NMPA Announced on Issuing the Administrative Measures for…
  533. 21 CFR 814.108: Supplemental applications.
  534. Webinar on submissions of parallel distribution notifications for centrally authorised…
  535. MDR_G.S.R. 777(E) dt_14.10.2022_exemption of non sterile and non measuring Class A medical…
  536. Summary of requirements for active substances in the quality part of the dossier…
  537. EMEA-003075-PIP01-21 - paediatric investigation plan
  538. Padcev - opinion on variation to marketing authorisation
  539. Committee for Medicinal Products for Veterinary Use (CVMP): 05-07 November 2024
  540. Bevacizumab (r-DNAorigin) drug product100mg/4ml& 400mg/16m
  541. Merged existing Medical Devices risk-classification
  542. All herbal community lists
  543. ema-inspections-proceduresInspections procedures
  544. Notification of a new proprietary ingredient
  545. Easing Pandemic Sparks Telemedicine Worries
  546. Standardised units of measurement
  547. Safety Study of Atezolizumab
  548. Committee for Herbal Medicinal Products (HMPC): 21-22 November 2011
  549. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24…
  550. Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102)
  551. QMS P0007: Control of Quality Records Procedure
  552. ema-besponsaBesponsa
  553. Tetanus Vaccine (Adsorbed) I. P.
  554. Drug Alert list for month of July 2023
  555. ema-coliprotec-f4-f18Coliprotec F4/F18
  556. Clinical investigation of medicinal products for the treatment of asthma - Scientific…
  557. 21 CFR 26.79: Territorial application.
  558. EU/3/10/838 - orphan designation for treatment of post-essential thrombocythaemia…
  559. cdsco-satralizumabSATRALIZUMAB
  560. Metoprolol Succinate ER + Chlorthalidone + Telmisartan (50mg+12.5mg+40mg…
  561. Points to Consider for the Design of Clinical Trials to Assess the Effects of Psychotropic…
  562. Notice-Online Application for the issuance of Form 41 (Registration certificate) and Form…
  563. Overview of the current regulatory testing requirements for medicinal products for human…
  564. EU/3/10/848 - orphan designation for treatment of calciphylaxis
  565. Nivolumab 10mg/ml(100 mg/10 mL) concentrate for solution for infusion
  566. European Medicines Agency recommends lifting suspension of aprotinin
  567. Paediatric Committee (PDCO): 7-9 October 2015
  568. Committee for medicinal products for veterinary use: Meeting of 13 to 15 July 2004
  569. EMA recommends expanding remdesivir compassionate use to patients not on mechanical…
  570. Benefit-risk review of Multaq started
  571. EU/3/20/2256 - orphan designation for treatment of amyotrophic lateral sclerosis
  572. AS P0020.002: Special On Site Assessment Procedure
  573. Measles, Mumps, Rubella and Varicella vaccine (Live attenuated, Freeze dried)
  574. 26th meeting of the Committee for Orphan Medicinal Products
  575. Committee for Advanced Therapies (CAT): 6-8 November 2019
  576. cdsco-pasireotidePasireotide
  577. Datopotamab deruxtecan (DS-1062a) 100mg/ vial; 2. Rilvegostomig (AZD2936) 750mg/vial…
  578. Third European Medicines Agency-Medicines for Europe bilateral meeting
  579. ema-striascanStriascan
  580. FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver…
  581. ema-amversioAmversio
  582. 21 CFR 862.1175: Cholesterol (total) test system.
  583. Managing the Domino Effect of International Standards Revision
  584. ema-immunologicals-stabilityImmunologicals: stability
  585. ema-nimesulide-referralNimesulide - referral
  586. EMEA-003044-PIP01-21 - paediatric investigation plan
  587. European Medicines Agency recommends authorisation of first generic medicine for human use
  588. ema-ivabradine-zentivaIvabradine Zentiva
  589. Second 2017 meeting of the coordinating group of the European network of paediatric…
  590. Medical devices: software applications (apps): Appendix 2 - clinical calculators
  591. Chimpanzee Adenovector Corona Virus Vaccine (BBV152)
  592. 21 CFR 878.4783: Negative pressure wound therapy device for reduction of wound…
  593. EMEA-002468-PIP04-18 - paediatric investigation plan
  594. Creutzfeldt-Jakob disease and advanced therapy medicinal products - Scientific guideline
  595. Clinical investigation of medicinal products for the treatment of attention deficit…
  596. Committee for Medicinal Products for Veterinary Use (CVMP): 15-17 March 2016
  597. ema-sortis-referralSortis - referral
  598. PSUSA/00000171/202102 - periodic safety update report single assessment
  599. PSUSA/00002647/201510 - periodic safety update report single assessment
  600. European Medicines Agency updates on ongoing safety review of sibutramine: Weight-loss…
  601. GN-23-R1-1 Guidance on Labelling for Medical Devices [ARCHIVED on 22 Sep 2022] [PDF, 522…
  602. EMEA-000343-PIP01-08 - paediatric investigation plan
  603. DR_G.S.R. 287(E) dt_08.03.2016_Amendment SchY_PSUR, Systemic Toxicity studies
  604. Hamamelidis cortex - herbal medicinal product
  605. PSUSA/00001499/201602 - periodic safety update report single assessment
  606. Gadoteridol 279.3mg/ml Injection
  607. European Medicines Agency Human Scientific Committees' Working Party with Patients' and…
  608. cdsco-iodixanolIodixanol
  609. Draft Guidance Document: Applications for Medical Device Investigational Testing…
  610. EU/3/13/1225 - orphan designation for treatment of hepatitis delta virus infection
  611. Teneligliptin hydrobromide hydrate eq to Teneligliptin IP + Dapagliflozin Propanediol…
  612. Paper calls for continued support for development of advanced therapies
  613. Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing
  614. GN-24-R2 Guidance on the Change of Registrant (2025 Jul) PUB
  615. European Medicines Agency's Management Board endorses work programme 2013
  616. EMEA-001748-PIP01-15-M01 - paediatric investigation plan
  617. CHMP: Working parties and other groups
  618. PSUSA/00002427/201806 - periodic safety update report single assessment
  619. Details of Importers whose permissions have been suspended / cancelled 2022
  620. 21 CFR 864.1865: Cervical intraepithelial neoplasia (CIN) test system.
  621. AAMI News, July 2020, Vol.55, No.7
  622. Application for leave or for extension of leave(Related to Employees)
  623. EMEA-000380-PIP01-08-M04 - paediatric investigation plan
  624. ema-imatinib-accordImatinib Accord
  625. Donald Armstrong: Hire Biomeds for Attitude, Train for Skill
  626. EMEA-001193-PIP01-11 - paediatric investigation plan
  627. 2026.06.23 G.S.R. 515(E)_Draft notification regarding amendments under Medical Devices…
  628. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November…
  629. Regulatory information – 1.7% increase of fees from 1 April 2018
  630. EU/3/12/1004 - orphan designation for treatment of gastric cancer
  631. 21 CFR 864.8950: Russell viper venom reagent.
  632. William Hyman: The Mystery of ‘Updated’ FDA Web Pages
  633. 21 CFR 880.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  634. New Study Finds Pre- and Post- Pandemic Medical Device Shortages
  635. 21 CFR 862.1509: Methylmalonic acid (nonquantitative) test system.
  636. EudraVigilance system overview
  637. EU/3/09/716 - orphan designation for treatment of chronic myeloid leukaemia
  638. European Commission closes infringement procedure against Roche
  639. 21 CFR 884.5100: Obstetric anesthesia set.
  640. Prescription medicines registration process
  641. Risk classification list of medical devices pertaining to Oncology
  642. cdsco-expec9vExPEC9V
  643. Valproate Pregnancy Prevention Programme: temporary advice for management during…
  644. ema-zavescaZavesca
  645. EU/3/20/2393 - orphan designation for treatment of Pitt-Hopkins syndrome
  646. EMEA-002155-PIP01-17 - paediatric investigation plan
  647. Articles About AI, Cybersecurity, and Alarm System Safety Recognized with AAMI Award
  648. PSUSA/00000902/201712 - periodic safety update report single assessment
  649. EU/3/02/128 - orphan designation for adjunctive treatment in patients at risk of…
  650. Stakeholder consultation for feedback on SEC meetings dated 22.04.2024
  651. 21 CFR 73.2110: Bismuth citrate.
  652. ema-azomyrAzomyr
  653. Committee for Orphan Medicinal Products (COMP): 16-18 June 2020
  654. RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD)
  655. Modernising the orphan designation process
  656. Crisis preparedness and management
  657. Drug Alert list for month of November 2020
  658. State Drug Alert for the Month of August 2024
  659. ema-saveneSavene
  660. SPOR and xEVMPD Stakeholder Engagement Webinars : Referentials Management Service (RMS)
  661. Committee for medicinal products for veterinary use: Meeting of 15-17 September 2009
  662. EU/3/20/2275 - orphan designation for treatment of insulin autoimmune syndrome
  663. ECDC and EMA update on COVID-19
  664. Three-Dimensional Printing Needs AI to Truly Become ‘Point of Care’
  665. PSUSA/00010285/201807 - periodic safety update report single assessment
  666. EMEA-001055-PIP01-10 - paediatric investigation plan
  667. Regulations Governing the Inspection of the Medical Device Quality Management System and…
  668. EU/3/12/1050 - orphan designation for treatment of traumatic spinal cord injury
  669. Handling of Application for Confirmation of Change Protocol Related to Change of Strains…
  670. Chapter 10 - General Advice on Vigilance - Northern Ireland
  671. EMEA-000254-PIP01-08 - paediatric investigation plan
  672. EU/3/23/2759 - orphan designation for treatment of amyotrophic lateral sclerosis
  673. ema-nintedanib-accordNintedanib Accord
  674. Regulatory information – Changes in SME registration procedures to reduce administrative…
  675. 21 CFR 803.11: What form should I use to submit reports of individual adverse events and…
  676. cdsco-js016JS016
  677. Medicinal Products (Prescription and Control of Supply) (Amendment) (No 4) Regulations…
  678. European Medicines Agency (EMA) Healthcare Professionals' (HCPWP) Working Party meeting
  679. cdsco-zy-19489ZY-19489
  680. EU/3/12/997 - orphan designation for treatment of schwannoma
  681. Xeloda / Capecitabine Accord / Capecitabine Medac / Capecitabine Teva / Ecansya…
  682. PSUSA/00010326/201607 - periodic safety update report single assessment
  683. EU/3/11/864 - orphan designation for treatment of mucopolysaccharidosis VI (Maroteaux-Lamy…
  684. EU/3/10/841 - orphan designation for treatment of non-24-hour sleep-wake disorders in…
  685. 21 CFR 872.6870: Disposable fluoride tray.
  686. EMEA-002535-PIP03-19 - paediatric investigation plan
  687. EMEA-000018-PIP01-07-M12 - paediatric investigation plan
  688. 21 CFR 1.1114: How does an accreditation body apply to FDA for recognition or renewal of…
  689. ema-ocaliva-referralOcaliva - referral
  690. Clinical Trials Information System (CTIS) bitesize talk: Modifications
  691. EMEA-001238-PIP01-12 - paediatric investigation plan
  692. Avoiding the ‘HIPAA Hole’: Will Patient Privacy Rules Trip Up Telehealth Progress?
  693. EMEA-coordinated PROTECT project has been accepted for funding by the Innovative Medicines…
  694. EU/3/10/834 - orphan designation for treatment of acute peripheral arterial occlusion
  695. Adjustment for baseline covariates in clinical trials - Scientific guideline
  696. PSUSA/00002429/201704 - periodic safety update report single assessment
  697. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  698. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  699. Milk Safety Program
  700. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - May 2017
  701. ema-protopyProtopy
  702. Information day on new services and systems in pharmacovigilance: preparing for business…
  703. 21 CFR 56.114: Cooperative research.
  704. ema-zyrtec-referralZyrtec - referral
  705. EMEA-001150-PIP03-22 - paediatric investigation plan
  706. Withaniae somniferae radix - herbal medicinal product
  707. EU/3/05/290 - orphan designation for treatment of Ep-CAM-YES squamous cell carcinoma of…
  708. hsa-telehealth-products-r2-1Telehealth Products R2.1
  709. EU/3/13/1103 - orphan designation for treatment of chronic thromboembolic pulmonary…
  710. Assessment of bioavailability of bound residues in food commodities of animal origin in…
  711. Promoting high-quality clinical research in children through strengthened international…
  712. Notice regarding Pre-submission meeting
  713. cdsco-lnp023-rituximabLNP023(Rituximab)
  714. ema-rabigen-sag2Rabigen SAG2
  715. 21 CFR 73.2150: Dihydroxyacetone.
  716. 21 CFR 25.10: Policies and NEPA planning.
  717. Recommendations issued for 2011/2012 seasonal flu vaccine composition
  718. cdsco-capmatinibCapmatinib
  719. Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA…
  720. ema-tauvidTauvid
  721. PSUSA/00000197/202102 - periodic safety update report single assessment
  722. Methodological issues with pharmacogenomic biomarkers in relation to clinical development…
  723. International regulators’ recommendations on COVID-19 vaccines and the Omicron variant
  724. ema-sirturoSirturo
  725. Medicinal Products (Control of Manufacture) Regulations 2007 (SI 539/2007) [Establishment…
  726. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 April…
  727. EMEA-001975-PIP01-16-M02 - paediatric investigation plan
  728. Rituzena (previously Tuxella)
  729. EU/3/04/208 - orphan designation for treatment of polycythaemia vera
  730. EMA multi-stakeholder workshop on qualification of novel methodologies
  731. Regulatory status of software (including apps) used in the diagnosis, treatment and…
  732. 21 CFR 864.3700: Whole slide imaging system.
  733. 21 CFR 74.2254: D&C Orange No. 4.
  734. 21 CFR 866.5870: Thyroid autoantibody immunological test system.
  735. EMEA-002267-PIP02-19 - paediatric investigation plan
  736. SGLT2 inhibitors - referral
  737. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 September 2010
  738. EMEA-001716-PIP05-20 - paediatric investigation plan
  739. Curcumin (Biocurcumax cap) as an adjunct drug to standard therapy [(Artesunate) +…
  740. Thiocolchicoside-containing medicines - referral
  741. cdsco-deupirfenidone-lyt-100Deupirfenidone (LYT-100)
  742. Partial Revision of “Designation of Orphan Drugs etc.”
  743. Step into the ‘AAMI Alligator Tank’ at AAMI eXchange REWIRED
  744. EU/3/20/2269 - orphan designation for treatment of hepatocellular carcinoma
  745. Committee for Medicinal Products for Human Use (CHMP): 21-24 July 2025
  746. MORE Registrations - user reference guide
  747. cdsco-picrorhiza-kurroaPicrorhiza kurroa
  748. Are Artificial Intelligence and Machine Learning Technologies Enabling or Hindering Health…
  749. Management Board meeting: 19-20 March 2014
  750. Comments invited on joint EU-Japan reflection paper on medicines delivered using…
  751. 21 CFR 890.5650: Powered inflatable tube massager.
  752. Partial Revision of "Handling of Designation of Drugs for Specific Use"
  753. MedTech Mitra's In-Vitro Diagnostic Innovators Handbook
  754. Non-clinical documentation in applications for marketing authorisation / registration of…
  755. cdsco-ct-p42CT-P42
  756. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical…
  757. nbcg-mdeg-reportMDEG Report
  758. The Poisons Standard and medical devices
  759. Vaccines for pandemic influenza
  760. Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin + Dapagliflozin tablets (Phase…
  761. EMEA-000669-PIP01-09-M02 - paediatric investigation plan
  762. Explanatory note to GVP module VII
  763. EU/3/10/825 - orphan designation for treatment of colchicine poisoning
  764. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018
  765. Clinical pharmacology and pharmacokinetics: questions and answers
  766. Quality aspects of single-dose veterinary spot-on products - Scientific guideline
  767. Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of…
  768. 21 CFR 878.3910: Noninflatable extremity splint.
  769. Trastuzumab 150 mg lyophilized powder in Single Dose Vial
  770. Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April…
  771. Info session on web-based electronic Application Form (eAF) add package
  772. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8…
  773. PSUSA/00010354/201705 - periodic safety update report single assessment
  774. cdsco-masitinib-vs-placeboMasitinib vs Placebo
  775. EU/3/18/2069 - orphan designation for treatment of idiopathic pulmonary fibrosis
  776. ema-duzalloDuzallo
  777. PSUSA/00002972/202110 - periodic safety update report single assessment
  778. Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on…
  779. ema-tolperisone-referralTolperisone - referral
  780. ema-cookiesCookies
  781. EMEA-000888-PIP01-10 - paediatric investigation plan
  782. 21 CFR 870.4075: Endomyocardial biopsy device.
  783. NMPA Announcement on Issuance and Implementation of the Measures for the Administration of…
  784. EMA experts awarded for excellence in standards development
  785. Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring…
  786. NM8074 (Recombinant humanized monoclonal antibody)
  787. Challan (TR-6) for depositing fee(For Stakeholders)
  788. EMEA-002956-PIP01-21 - paediatric investigation plan
  789. ema-orphan-incentivesOrphan incentives
  790. Can measuring anticoagulant activity and concentration in the body play a role in clinical…
  791. Drug Alert list for month of February 2018
  792. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29…
  793. EMEA recommends new warnings and contraindications for rosiglitazone
  794. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for sponsors…
  795. PSUSA/00001764/201505 - periodic safety update report single assessment
  796. EMEA-002558-PIP01-19 - paediatric investigation plan
  797. Public stakeholder meeting: development and authorisation of safe and effective COVID-19…
  798. 21 CFR 2.125: Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.
  799. Setting specifications for related impurities in antibiotics - Scientific guideline
  800. ema-emdocamEmdocam
  801. PSUSA/00001696/202011 - periodic safety update report single assessment
  802. New medicine to help in the fight against antimicrobial resistance
  803. 21 CFR 870.3710: Pacemaker repair or replacement material.
  804. Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2020
  805. EU/3/22/2733 - orphan designation for treatment in haematopoietic stem cell…
  806. UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety…
  807. 21 CFR 880.5270: Neonatal eye pad.
  808. Xenogeneic cell-based medicinal products - Scientific guideline
  809. cdsco-oav101OAV101
  810. 21 CFR 872.4620: Fiber optic dental light.
  811. EU/3/20/2383 - orphan designation for treatment of respiratory distress syndrome
  812. ema-alvesco-referralAlvesco - referral
  813. EMEA-001757-PIP02-15-M03 - paediatric investigation plan
  814. Committee for Herbal Medicinal Products (HMPC): 4-6 May 2020
  815. Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 October 2014
  816. Paliperidone Palmitate Prolonged Release Suspension for Injection 25mg/50mg/75mg/100mg and…
  817. 21 CFR 26.72: Sectoral contact points.
  818. EMA confirms WeWork as new sub-tenant for 30 Churchill Place; EMA also settles court case…
  819. EMEA-000612-PIP01-09 - paediatric investigation plan
  820. Concept paper for the development of a reflection paper on a tailored clinical approach in…
  821. PSUSA/00003175/202103 - periodic safety update report single assessment
  822. EU/3/15/1543 - orphan designation for treatment of mitochondrial encephalomyopathy, lactic…
  823. ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - data…
  824. EU/3/03/178 - orphan designation for treatment of pulmonary arterial hypertension and…
  825. Baxdrostat Tablets 1 mg or 2 mg or placebo
  826. Bayovac IBR Marker Vivum - referral
  827. PSUSA/00010441/202004 - periodic safety update report single assessment
  828. 21 CFR 872.1740: Caries detection device.
  829. EU/3/08/563 - orphan designation for treatment of traumatic spinal cord injury
  830. Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation…
  831. ema-temozolomide-sandozTemozolomide Sandoz
  832. cdsco-bms-986369-cc-99282BMS-986369 CC-99282
  833. ema-champixChampix
  834. PSUSA/00002102/201605 - periodic safety update report single assessment
  835. 21 CFR 870.4420: Cardiopulmonary bypass cardiotomy return sucker.
  836. Dissolution specification for generic oral immediate release products
  837. cdsco-selinexor-kpt-330Selinexor (KPT-330
  838. 21 CFR 888.5850: Nonpowered orthopedic traction apparatus and accessories.
  839. ema-acrescentAcrescent
  840. Rob Jensen: Taking a Side in the Debate over Medical Device Service
  841. EMEA-001332-PIP01-12-M06 - paediatric investigation plan
  842. 21 CFR 864.9225: Cell-freezing apparatus and reagents for in vitro diagnostic use.
  843. ema-equilis-prequenzaEquilis Prequenza
  844. Career Center: Looking for a Job or a Candidate? AAMI Career Center Can Help
  845. cdsco-ct-p13CT-P13
  846. Esmya: new measures to minimise risk of rare but serious liver injury
  847. Stem Cell Treatment and Advertisements for various diseases
  848. PSUSA/00002310/202308 - periodic safety update report single assessment
  849. European Medicines Agency/European Federation of Pharmaceutical Industries and…
  850. Notice: Static Magnets Sold as Medical Devices
  851. P/3/2010 - paediatric investigation plan
  852. EU/3/17/1870 - orphan designation for treatment of mitochondrial DNA depletion syndrome…
  853. Telehealth Products R2.1 [PDF, 1.23 MB]
  854. PSUSA/00001738/202307 - periodic safety update report single assessment
  855. Private Label Medical Devices: Questions and Answers
  856. PSUSA/00010299/201803 - periodic safety update report single assessment
  857. NOTICE regarding Not of Standard Quality Combipack ABD
  858. cfr-21-cfr-888-1-scope21 CFR 888.1: Scope.
  859. EMEA-000266-PIP01-08-M01 - paediatric investigation plan
  860. Targocid and associated names - referral
  861. Warning against use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory…
  862. Joint-Team-NB-IG-NB-PositionPaper-AI-in-MD-Questionnaire-V1.1
  863. Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
  864. Nanotop and associated names - referral
  865. DARWIN EU Advisory Board meeting - 11 December 2023
  866. Second international awareness session for international regulators, academia and…
  867. EMEA-002939-PIP01-20 - paediatric investigation plan
  868. Committee for Orphan Medicinal Products (COMP): 8-9 November 2011
  869. Joint workshop with representatives from patients', consumers' and healthcare…
  870. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations…
  871. Regulation for the Issuance and Management of Western Pharmaceuticals Distribution…
  872. PSUSA/00003135/201812 - periodic safety update report single assessment
  873. PSUSA/00010299/201508 - periodic safety update report single assessment
  874. EU/3/24/2939 - orphan designation for treatment of systemic sclerosis
  875. Management Board meeting: 15-16 June 2022
  876. February 2nd 2017 GSR 102(E)
  877. EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
  878. New Postmarket Cybersecurity Responsibilities Poised to Have Major Impact on Device…
  879. 21 CFR 822.14: May I reference information previously submitted instead of submitting it…
  880. cfr-21-cfr-73-450-riboflavin21 CFR 73.450: Riboflavin.
  881. Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 November 2015
  882. Training on electronic reporting of individual case safety reports (ICSRs) to…
  883. Registration open for Committee for Advanced Therapies stakeholders workshop
  884. EU/3/20/2364 - orphan designation for treatment of retinitis pigmentosa
  885. 21 CFR 870.1310: Vessel dilator for percutaneous catheterization.
  886. Voriconazole Hikma (previously Voriconazole Hospira)
  887. Paediatric Committee (PDCO): 15-18 October 2024
  888. EU/3/16/1743 - orphan designation for treatment of neonatal encephalopathy
  889. 21 CFR 11.200: Electronic signature components and controls.
  890. Post-authorisation procedures
  891. EU/3/09/632 - orphan designation for treatment of acute intermittent porphyria
  892. EMEA-000639-PIP03-16-M02 - paediatric investigation plan
  893. 21 CFR 73.37: Astaxanthin dimethyldisuccinate.
  894. PSUSA/00000812/202006 - periodic safety update report single assessment
  895. EU/3/10/795 - orphan designation for treatment of Hodgkin's lymphoma
  896. EU/3/10/822 - orphan designation for treatment of Fanconi anaemia type A
  897. Acenocoumarol product-specific bioequivalence guidance
  898. European Medicines Agency recommends new advice on safer use of fibrin sealant spray…
  899. Buying veterinary medicines online
  900. CANCELLED: March 20, 2023: Joint Meeting of the Nonprescription Drugs Advisory Committee…
  901. 21 CFR 880.2720: Patient scale.
  902. Medical Device Work Order Types Standardized by CMMS Collaborative
  903. In Memoriam: Marvin Dale Shepherd
  904. AAMI Guidance Helps ‘Clean Up’ Medical Device Instructions for Use
  905. cdsco-moroctocog-alfaMoroctocog alfa
  906. March 7, 2017: Pediatric Advisory Committee Meeting Announcement - 03/07/2018
  907. European Union clinical trials portal and Union database: Meeting with stakeholders
  908. 21 CFR 882.1925: Ultrasonic scanner calibration test block.
  909. Committee for Medicinal Products for Human Use (CHMP): 22-25 May 2023
  910. EMEA-001663-PIP01-14 - paediatric investigation plan
  911. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 19-22…
  912. cdsco-ms-veedaMS/ Veeda
  913. Committee for Advanced Therapies (CAT): 6-8 December 2017
  914. PSUSA/00010354/201505 - periodic safety update report single assessment
  915. Office Memorandum-dated 16.08.2011: Monitoring of functioning of all Port Offices of…
  916. Enforcement Rules of Medical Devices Act
  917. cdsco-vedolizumab-ivVedolizumab IV
  918. Details of Importers whose permissions/ licenses have been suspended/cancelled
  919. Rules for the sale, supply and administration of medicines
  920. cdsco-edoxaban-tosylateEdoxaban tosylate
  921. ema-tresibaTresiba
  922. Keytruda - withdrawal of application for variation to marketing authorisation
  923. New Type of AAMI Resource Aims to Address Need for Rapid Guidance
  924. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July…
  925. cdsco-letrozole-tablet-5-mgLetrozole Tablet 5 mg
  926. Team-NB PositionPaper NB-ConfirmationLetterEU2023-607 V2
  927. Supply unlicensed medicinal products (specials): The supply of unlicensed medicinal…
  928. EU requirements for batches with maximum and minimum titre or batch potency for…
  929. Single-use medical devices: implications and consequences of re-use
  930. Formulating responses to GCP inspection findings
  931. 21 CFR 878.4450: Nonabsorbable gauze for internal use.
  932. Exploring opportunities for collaboration between regulators and healthcare payers
  933. Development pharmaceutics - Scientific guideline
  934. ema-dafiro-hctDafiro HCT
  935. EU/3/16/1698 - orphan designation for treatment of bullous pemphigoid
  936. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20…
  937. cdsco-azd2693AZD2693
  938. 21 CFR 1.77: Radiation-emitting electronic products.
  939. Antibiotic resistance guidance
  940. cdsco-apixabanApixaban
  941. 21 CFR 1.681: How frequently must eligible entities be recertified?
  942. EMEA-001504-PIP01-13 - paediatric investigation plan
  943. How Is Standards Development ‘Addictive’? 2023 AAMI Fellow Explains
  944. Committee for Orphan Medicinal Products (COMP): 6-8 October 2015
  945. ema-gG
  946. EMEA-000653-PIP01-09-M05 - paediatric investigation plan
  947. Latanoprost - paediatric investigation plan
  948. Security Breach Affects 90,000 Patients
  949. ema-industry-standing-groupIndustry Standing Group
  950. ema-virbagen-omegaVirbagen Omega
  951. Committee for Advanced Therapies (CAT): 14-15 February 2013
  952. EU/3/14/1401 - orphan designation for treatment of traumatic spinal cord injury
  953. Committee for Advanced Therapies (CAT): 5-7 October 2022
  954. PSUSA/00000267/202212 - periodic safety update report single assessment
  955. Destroy of the product demaged due to fire
  956. ICH guideline E11A on pediatric extrapolation - Scientific guideline
  957. Cannabis flos - herbal medicinal product
  958. 21 CFR 880.5410: Neonatal transport incubator.
  959. 21 CFR 862.3555: Lidocaine test system.
  960. PSUSA/00001356/201712 - periodic safety update report single assessment
  961. March 24-25, 2021: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety…
  962. External Performance evaluation of IVD's under MDR further guidance
  963. FDA requires multiple new safety measures for leukemia drug Iclusig; company expected to…
  964. Metformin Hydrochloride IP (as sustained release) + Teneligliptin Hydrobromide Hydrate IP…
  965. 21 CFR 73.1645: Aluminum powder.
  966. EU/3/14/1362 - orphan designation for treatment of idiopathic pulmonary fibrosis
  967. ema-komboglyzeKomboglyze
  968. cdsco-scrub-typhus-intrestScrub Typhus INTREST
  969. PSUSA/00001769/202004 - periodic safety update report single assessment
  970. EMEA-001329-PIP01-12 - paediatric investigation plan
  971. 21 CFR 874.1100: Earphone cushion for audiometric testing.
  972. Committee for Advanced Therapies (CAT): 16-17 June 2011
  973. EMEA-001323-PIP01-12 - paediatric investigation plan
  974. Medical Devices Alert on MiniMed 620G Insulin Pump/Pump Kits & MiniMed 640G Insulin…
  975. EMEA-001340-PIP01-12-M03 - paediatric investigation plan
  976. Adhatodae vasicae folium - herbal medicinal product
  977. CVMP interested parties' meeting
  978. EMEA-003380-PIP01-22 - paediatric investigation plan
  979. European Medicines Agency recommends suspension of oral buflomedil-containing medicines
  980. Q&A clinic on Product Management Service (PMS) Product User Interface - 13 June 2024
  981. PSUSA/00000438/202310 - periodic safety update report single assessment
  982. EMEA-000901-PIP04-17-M02 - paediatric investigation plan
  983. Bilastine + Montelukast Sodium IP eq. to Montelukast uncoated tablet (Phase III)
  984. EU/3/16/1707 - orphan designation for treatment of citrullinaemia type 1
  985. Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on…
  986. Bicalutamide 150 mg - referral
  987. Union Pharmacovigilance Database: webinar on adverse event collection and recording
  988. Report of the Expert Committee to address the Issue of Faulty ASRâ„¢ Hip Implants (Dr…
  989. Emtricitabine/tenofovir disoproxil product-specific bioequivalence guidance
  990. Inactivated Hepatitis A Vaccine (Adsorbed) I.P.6nov
  991. ema-efavirenz-tevaEfavirenz Teva
  992. Handling of Performance Evaluation Tests of Diagnostic Medical Devices Using Existing…
  993. Management Board meeting: 1 October 2020

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