Global regulations and guidance

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

1. Rewards and incentives for paediatric medicines
2. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19…
3. Using Organisations Management Services (OMS) and Referentials Management Service (RMS)…
4. Porcilis PCV ID - opinion on variation to marketing authorisation
5. EU/3/05/281 - orphan designation for treatment of idiopathic pulmonary fibrosis
6. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate…
7. Fluad Tetra - opinion on variation to marketing authorisation
8. PSUSA/00000420/202111 - periodic safety update report single assessment
9. Submission of Post Approval Changes Applications through SUGAM Portal
10. 21 CFR 862.2900: Automated urinalysis system.
11. Scientific guidelines for veterinary medicines
12. ema-fosavanceFosavance
13. ema-upsteldaUpstelda
14. Virtual live hands-on training course for clinical trials sponsors using EudraVigilance…
15. Annual report 2011 shows continuously high level of activities
16. Third Meeting of the Management Board of the European Agency for the Evaluation of…
17. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July…
18. Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices
19. EMEA's provision of information to the EMEA's stakeholders
20. Clinical Trials Information System (CTIS): Walk-in clinic - 5 May 2022
21. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 8-10 February 2011
22. ema-apexelsinApexelsin
23. 21 CFR 872.1870: Sulfide detection device.
24. Typhoid Conjugate Vaccine (Monovalent)
25. Bisoprolol fumarate / acetylsalicylic acid - paediatric investigation plan
26. Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Group…
27. Bilastine + Dextromethorphan Hydrobromide + Phenylephrine Hydrochloride syrup (Phase III)
28. Signed Request Form for Buffer Stock Application Type
29. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 29…
30. Eleventh Meeting of the Management Board
31. Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2010…
32. EMEA-002136-PIP01-17 - paediatric investigation plan
33. 21 CFR 864.9100: Empty container for the collection and processing of blood and blood…
34. ema-jubbontiJubbonti
35. AS F0005.3.001: AO Assessment Program Approval Form
36. PSUSA/00000616/202012 - periodic safety update report single assessment
37. EU/3/08/558 - orphan designation for treatment of acute myeloid leukaemia
38. Voices of Cybersecurity: Michelle Jump
39. UK Parallel Import Licences Following Agreement of the Windsor Framework
40. Committee for Orphan Medicinal Products: February 2006 meeting
41. 21 CFR 866.2420: Oxidase screening test for gonorrhea.
42. PSUSA/00000444/201612 - periodic safety update report single assessment
43. PSUSA/00001910/202012 - periodic safety update report single assessment
44. cdsco-rsvpref3RSVPreF3
45. EU/3/15/1498 - orphan designation for treatment of cystic fibrosis
46. Sales of antibiotics for animal use decrease by 13% in Europe between 2011 and 2015
47. PSUSA/00001450/201911 - periodic safety update report single assessment
48. Fasturtec - direct healthcare professional communication (DHPC)
49. 21 CFR 884.6170: Assisted reproduction water and water purification systems.
50. PSUSA/00002856/201610 - periodic safety update report single assessment
51. Fimasartan Potassium + Chlorthalidone IP tablets (Phase III)
52. 21 CFR 860.15: Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug…
53. EU/3/19/2179 - orphan designation for treatment of hyperargininaemia
54. Cooperation between regulators and HTA bodies creates synergies
55. cdsco-omalizumab150-mg-mlOmalizumab150 mg/ml
56. Considerations for Updated Ethics Frameworks for Use of Digital Data
57. ema-entacapone-tevaEntacapone Teva
58. Webinar presentation: Manufacturing investigational medicinal products
59. Announcing 2021 Members to AAMI HTM Leadership Groups
60. Format and content of applications for agreement or modification of a Paediatric…
61. Training opportunities for non-EU regulators
62. Further data needed to determine risk of heart attack with abacavir
63. European Medicines Agency recommends authorisation of first bluetongue vaccine through…
64. Notification on Approval Application for In Vitro Companion Diagnostics and Corresponding…
65. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May…
66. ema-hypnovel-referralHypnovel - referral
67. ema-flexicamFlexicam
68. Classification of Medical Device Pertaining to Radiotherapy under the Provisions of…
69. Testing of Biochemical kits for estimation of glucose
70. ema-rayvowRayvow
71. Assessing your compliance with the Food and Drugs Act
72. ema-orgalutranOrgalutran
73. PSUSA/00000989/202106 - periodic safety update report single assessment
74. ema-duoplavinDuoPlavin
75. EU/3/12/1007 - orphan designation for treatment of retinitis pigmentosa
76. PSUSA/00001535/202201 - periodic safety update report single assessment
77. 21 CFR 884.1300: Uterotubal carbon dioxide insufflator and accessories.
78. Fee-related incentives for advanced-therapy medicines to expire on 30 December 2012
79. nbcg-leaflet-pms-training-2Leaflet PMS Training 2
80. Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Test Kits intended to be…
81. cdsco-levonadifloxacinLevonadifloxacin
82. Procedure for regularisation of FDCs w.r.t. payment of fees regarding
83. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 April 2013
84. CHMP elects new chair and vice-chair at its first meeting
85. EU/3/12/1056 - orphan designation for treatment of acute myeloid leukaemia
86. Management Board meeting: 19 March 2015
87. Crafting an intended purpose in the context of Software as a Medical Device (SaMD)…
88. 21 CFR 872.5525: Preformed tooth positioner.
89. 21 CFR 886.1640: Ophthalmic preamplifier.
90. Tech World: The Next Imperative in Medical Device Cybersecurity
91. Sprycel - Sprycel (dasatinib) and risk of pulmonary arterial hypertension
92. 21 CFR 820.65: Traceability.
93. 2026.02.02 G.S.R. 98(E)_Draft Notification regarding amendment in NDCT Rules, 2019 for…
94. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May…
95. Committee for Proprietary Medicinal Products (CPMP) 57th plenary meeting
96. EMEA-002868-PIP01-20 - paediatric investigation plan
97. PSUSA/00001079/201504 - periodic safety update report single assessment
98. EudraVigilance information day
99. EU/3/21/2516 - orphan designation for treatment of pancreatic cancer
100. PSUSA/00010378/201705 - periodic safety update report single assessment
101. Apremilast Film Coated 10/10/30mg Tablets
102. cdsco-alirocumabAlirocumab
103. ema-vizamylVizamyl
104. ema-oxlumoOxlumo
105. European Medicines Agency recommends extending use of Abraxane to include treatment of…
106. Committee for veterinary medicinal products: Meeting of 10 to 12 December 2002
107. PSUSA/00000034/201509 - periodic safety update report single assessment
108. (Attachment) Questions and Answers (Q & A) on Guidelines for Nonclinical Studies of…
109. EU/3/11/896 - orphan designation for treatment of cystic fibrosis
110. Questions and answers on the Haemagglutination Inhibition (HI) test for qualification of…
111. EMA closed 1 November 2019
112. Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids…
113. Committee for Orphan Medicinal Products: July 2004 meeting
114. March 13th 2018 GSR 222(E)
115. Procedure to be followed for subsequent applicants in respect of FDCs declared as rational…
116. cdsco-anifrolumabasAnifrolumabAs
117. Reproduce or re-use MHRA information
118. 21 CFR 862.1555: Phenylalanine test system.
119. NMPA Announcement on Issuing 5 Technical Review Guidances for Registration
120. EU/3/20/2258 - orphan designation for treatment of immune thrombocytopenia
121. Rienso - withdrawal of application for variation to marketing authorisation
122. ema-paediatric-regulationPaediatric Regulation
123. 21 CFR 20.2: Production of records by Food and Drug Administration employees.
124. PSUSA/00010291/201606 - periodic safety update report single assessment
125. Guideline on clinical investigation of medicinal products for the treatment of acute heart…
126. EMEA-000118-PIP04-17 - paediatric investigation plan
127. Organisation Management System (OMS) Trouble Shooting Session for CTIS users - June 2022
128. EU/3/16/1699 - orphan designation for treatment of echinococcosis
129. Dircction under section 33P of the Drugs & Cosmetics Act, 1940 for issuance of…
130. 21 CFR 870.2320: Ballistocardiograph.
131. finerenone plus empagliflozin
132. EMEA-001586-PIP01-13 - paediatric investigation plan
133. EMEA-001230-PIP01-11-M05 - paediatric investigation plan
134. EU/3/17/1911 - orphan designation for treatment of pancreatic cancer
135. ema-lytenavaLytenava
136. EMEA-002198-PIP01-21 - paediatric investigation plan
137. 21 CFR 866.6030: AFP-L3% immunological test system.
138. Cooperation on medicines regulation intensified
139. EU/3/03/133 - orphan designation for treatment of angioedema
140. Recall of OZURDEX (Dexamethasone Intravitreal Implant 0.7mg)
141. Inspection of Medical Device Manufacturers
142. Sodium used as an excipient in medicinal products for human use
143. Fourth veterinary big data stakeholder forum
144. unadjuvanted RSV Maternal vaccine
145. EMEA-002744-PIP01-19 - paediatric investigation plan
146. EMEA-001061-PIP01-10-M03 - paediatric investigation plan
147. 21 CFR 870.2810: Paper chart recorder.
148. ema-benefit-risk-methodologyBenefit-risk methodology
149. FAQ in Vitro Diagnostic IVD Devices 2024
150. EMEA recommends a new warning for epoetins for their use in cancer patients
151. GN-23-R2 Guidance on Labelling for Medical Devices(2022 Sep) PUB [PDF, 293 KB]
152. EMA publishes 2013 annual report
153. EU/3/16/1779 - orphan designation for treatment of fibrodysplasia ossificans progressiva
154. 21 CFR 12.24: Ruling on objections and requests for hearing.
155. EMEA-001908-PIP01-15 - paediatric investigation plan
156. EU/3/24/2921 - orphan designation for treatment of hyperphenylalaninaemia
157. 21 CFR 1.900: Who is subject to this subpart?
158. ema-abiraterone-krkaAbiraterone Krka
159. EU/3/20/2250 - orphan designation for treatment of Duchenne muscular dystrophy
160. Management Board meeting: 5 May 2011
161. EMEA-002903-PIP03-21 - paediatric investigation plan
162. Paediatric Committee (PDCO): 19-22 March 2024
163. ema-dexxienceDexxience
164. Get to Know the AAMI Standards Team: Chenai Maguwah, Senior Manager
165. Evaluation of Drugs in rare diseases, Eudipharm & EMEA seminar
166. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 July 2021
167. Disposal/Rejection of Long-Pending Applications on Sugam Portal Awaiting Query Response
168. NMPA Issued the Administrative Measures for Key Laboratories of NMPA
169. AZD0901 Powder for solution for infusion (50 mg/vial)
170. EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
171. PSUSA/00000906/202005 - periodic safety update report single assessment
172. Methylcobalamin Nasal spray 500 mcg
173. Partial revision of "English version of the Standards for Marketing Approval of Cold…
174. Best practice guidance on patient information leaflets
175. HTM Professionals Provide Crucial FDA Feedback Using MedSun
176. Study: Bedside Portable MRI May be Effective in Safely Diagnosing Hemorrhagic Strokes
177. PSUSA/00010068/202207 - periodic safety update report single assessment
178. Application Form for Revised Investigational Testing Authorization (ITA)
179. Canagliflozin in Children
180. General guidance for listed medicines
181. Pharmacovigilance Risk Assessment Committee (PRAC): 25 - 28 November 2024
182. PSUSA/00001888/202204 - periodic safety update report single assessment
183. European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FVE) webinar on…
184. Assessment of the risk to public health from antimicrobial resistance due to the use of an…
185. 21 CFR 864.4020: Analyte specific reagents.
186. ACMD meeting statement, Meeting 31, 24 February 2017
187. EMEA-000380-PIP11-23 - paediatric investigation plan
188. Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized, allergenic extract…
189. 21 CFR 862.2270: Thin-layer chromatography system for clinical use.
190. EU/3/12/1057 - orphan designation for treatment of cutaneous T-cell lymphoma
191. EMEA-000698-PIP02-10-M01 - paediatric investigation plan
192. PSUSA/00010209/201702 - periodic safety update report single assessment
193. ema-infanrix-hepbInfanrix HepB
194. ema-aprotinin-referralAprotinin - referral
195. Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1…
196. cdsco-mdac-dentalMDAC Dental
197. 21 CFR 880.5420: Pressure infusor for an I.V. bag.
198. Clinical trials for medicines: guidance on compliance with ICH E6 good clinical practice…
199. Zonisamide product-specific bioequivalence guidance
200. Checklist for Form MD-16 IVD (Application for licence to Import medical devices for the…
201. List of clarifications and NOC issued from 2011 to 2017
202. Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
203. 21 CFR 882.5030: Methyl methacrylate for aneurysmorrhaphy.
204. Notice inviting quotation to dispose off unserviceable articles materials in CDL Kolkata…
205. Workshop on clinical investigation of new medicines for the treatment of multiple…
206. Paediatric Committee (PDCO): 22-24 June 2016
207. 21 CFR 882.5802: Transcranial magnetic stimulation system for neurological and psychiatric…
208. PSUSA/00002673/202012 - periodic safety update report single assessment
209. Metformin HCl (SR) + Myo-Inositol film coated bilayered tablets (Phase III)
210. Vantavo (previously Alendronate sodium and colecalciferol, MSD)
211. DR_G.S.R. 766(E) dt_21.10.2021_reg Rule 90,Form 29 deemed approval
212. EMEA-003034-PIP01-21 - paediatric investigation plan
213. ema-xenpozymeXenpozyme
214. Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)
215. Committee for Orphan Medicinal Products: December 2004 meeting
216. ema-imfinziImfinzi
217. ema-calcitonin-referralCalcitonin - referral
218. Guidance 23: Nonclinical studies
219. EMEA-000414-PIP02-11 - paediatric investigation plan
220. EMEA-002338-PIP03-21 - paediatric investigation plan
221. PRO details of all Zones/Sub Zones
222. European Medicines Agency releases guideline on biosimilar interferon beta for public…
223. cdsco-pegfilgrastimPegfilgrastim
224. SONOVUE (1) (sulphur hexafluoride): New contraindication in patients with heart disease…
225. Dorzolamide Hydrochloride 22.26mg eq. to Dorzolamide 20mg + Brimonidine Tartrate IP 1mg…
226. cfr-21-cfr-1-83-definitions21 CFR 1.83: Definitions.
227. Focus group on veterinary pharmacovigilance reporting in poultry
228. Aide Memoire on GMP Particularities for Clinical Trial Products
229. ema-foscanFoscan
230. ema-oxapexOxapex
231. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 January 2015
232. 21 CFR 886.1270: Exophthalmometer.
233. cdsco-aur107AUR107
234. Strengthening interaction with academia
235. EMEA-003015-PIP01-21 - paediatric investigation plan
236. GN-21-R4.6 Guidance on Change Notification for Registered MD [ARCHIVED on 17 Feb 2020]…
237. PSUSA/00010465/201612 - periodic safety update report single assessment
238. Cenobamate Tablets 12.5mg,25mg,50mg100mg,150mg,200mg
239. Equine Anti Covid Antibody Fragments F(ab)2
240. cfr-21-cfr-25-30-general21 CFR 25.30: General.
241. EU/3/20/2388 - orphan designation for treatment of congenital muscular dystrophy
242. European Medicines Agency widens public access to documents
243. EMEA-000794-PIP01-09-M01 - paediatric investigation plan
244. 21 CFR 1.278: Who is authorized to submit prior notice?
245. aami-we-heart-htmWe "Heart" HTM
246. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 October 2018
247. Regulation on Approval of Medical Device Clinical Trial Plan
248. Mifepristone 10/25 mg Tablet
249. Scientific advice for veterinary medicines
250. Skimmed cow's milk powder - paediatric investigation plan
251. EMEA-003165-PIP01-21 - paediatric investigation plan
252. PSUSA/00009271/201703 - periodic safety update report single assessment
253. 21 CFR 886.1500: Headband mirror.
254. 21 CFR 20.83: Disclosure required by court order.
255. 21 CFR 1.653: What must an accredited third-party certification body do when issuing food…
256. 21 CFR 870.1100: Blood pressure alarm.
257. Policy on veterinary medicines for minor use, minor species / limited market revised
258. Virion Inactivated Corona Virus Vaccine
259. EMEA-001331-PIP01-12-M02 - paediatric investigation plan
260. Product Management Services (PMS) deep-dive webinar
261. cdsco-finasteride-minoxidilFinasteride+Minoxidil
262. EU/3/07/445 - orphan designation for prevention of corneal graft rejection
263. EMEA-000315-PIP02-15-M03 - paediatric investigation plan
264. Alan Lipschultz: Pay Close Attention to TJC's Imaging Requirements
265. Metoprolol Succinate eq. to Metoprolol Tartrate IP + Azelnidipine IP tablets (Phase III)
266. New restrictions on use of medicines containing ergot derivatives
267. Core management documents
268. EU/3/18/2090 - orphan designation for treatment of haemophilia B
269. ema-ulunar-breezhalerUlunar Breezhaler
270. Making IT services for medicine regulation in Europe more efficient
271. ema-botox-referralBotox - referral
272. Chikungunya vaccine (Inactivated)
273. EMA's medical literature monitoring enters into full operation
274. Meeting highlights from the Paediatric Committee: 16 - 18 September 2009
275. European Medicines Agency recommends revoking authorisations of Caustinerf arsenical and…
276. Get Active for a Good Cause during the AAMI Exchange
277. Addendum to the note for guidance on antiarrhythmics on atrial fibrillation and atrial…
278. cdsco-filgotinib-safetyFilgotinib safety
279. Study Finds Patients More Likely to Accept Interventions from Humans than from AI…
280. EMEA-002435-PIP01-18-M03 - paediatric investigation plan
281. EU/3/09/672 - orphan designation for treatment of multiple myeloma
282. Expressions of interest invited for workshop on ethics of clinical trials in children
283. Regulations on Good Clinical Practice for Medical Devices
284. 21 CFR 876.5970: Hernia support.
285. Zetomipzomib KZR-616 30 mg or 60
286. ema-nasonex-referralNasonex - referral
287. 21 CFR 892.2050: Medical image management and processing system.
288. SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
289. European Medicines Agency launches new organisational structure and new visual identity
290. Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effectiv
291. EU/3/22/2707 - orphan designation for treatment of Guillain-Barré syndrome
292. Clinical investigation of medicinal products for the treatment of acute stroke…
293. Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2010
294. EMEA-002248-PIP01-17 - paediatric investigation plan
295. Meeting on monitoring of sales of veterinary antimicrobial agents in Europe
296. PSUSA/00001074/201507 - periodic safety update report single assessment
297. EMEA-001226-PIP01-11-M01 - paediatric investigation plan
298. Project Team Work Item (PTWI) Proposal / Approval Form
299. ema-blectiforBlectifor
300. Committee for Medicinal Products for Human Use (CHMP): 23-26 March 2020
301. Data submission on investigational medicines: guidance for clinical trial sponsors
302. Assessment of cardiovascular safety profile of medicinal products - Scientific guideline
303. Tacrolimus lipid tablet 3mg
304. Bioanalytical method validation - Scientific guideline
305. Ninth industry stakeholder platform on the operation of EU pharmacovigilance legislation
306. 21 CFR 870.1230: Fiberoptic oximeter catheter.
307. May 20-21, 2025: Meeting of the Oncologic Drugs Advisory Committee - 05/20/2025
308. EMEA-002149-PIP01-17 - paediatric investigation plan
309. Patients' and Consumers' Working Party/Healthcare Professionals' Working Group joint…
310. DR_G.S.R. 702(E) dt_14.10.1999_26A_reg combination of Vitamins (B1, B6 and B12)
311. 21 CFR 862.1805: Vitamin A test system.
312. EU/3/09/658 - orphan designation for treatment of acute promyelocytic leukaemia
313. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
314. FAQ (3DP Medical Devices) 2021 [PDF, 805 KB]
315. 2023.11.07_S.O. 4834(E)_In compliance to the Jan Vishwas (Amendment of Provisions) Act…
316. Test Formulation A: Dutasteride 0.05% w/w + Minoxidil 5% w/w & Test Formulation B…
317. Emergency Contact Information Form
318. Linagliptin + Dapagliflozin tablets (Phase III)
319. AC-203 Diacerein 1% Ointment
320. PSUSA-00001811-202207 - periodic safety update report single assessment
321. PSUSA/00010810/202304 - periodic safety update report single assessment
322. PSUSA/00010348/202109 - periodic safety update report single assessment
323. The Provisions for Registration and Filing of Cosmetics
324. EMEA-000811-PIP01-09 - paediatric investigation plan
325. EMEA-002926-PIP01-20 - paediatric investigation plan
326. 21 CFR 870.4220: Cardiopulmonary bypass heart-lung machine console.
327. ema-epysqliEpysqli
328. EMA reviewing safety of Uptravi for pulmonary arterial hypertension (updated)*
329. EMEA-002553-PIP01-19 - paediatric investigation plan
330. Committee for veterinary medicinal products: Meeting of 11 to 13 March 2003
331. ema-aripiprazole-sandozAripiprazole Sandoz
332. 21 CFR 58.215: Alternative or additional actions to disqualification.
333. Type-IA variations: questions and answers
334. EMEA-000907-PIP01-10 - paediatric investigation plan
335. Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 April 2022
336. Global regulators work towards strengthening collaboration on observational research…
337. EU/3/05/343 - orphan designation for treatment of glioma
338. 21 CFR 82.1260: D&C Orange No. 10.
339. Guidance Document Software as a Medical Device (SaMD): Definition and Classification
340. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
341. European Medicines Agency/CHMP Working Group with Healthcare Professionals' Organisations…
342. Identify and Engage! Building Your Medical Device Cybersecurity Risk Management Team
343. 21 CFR 868.5690: Incentive spirometer.
344. EU/3/16/1803 - orphan designation for treatment of progressive myoclonic epilepsy type 2…
345. Meeting highlights from the Paediatric Committee: 4 - 6 February 2009
346. PSUSA/00010378/202305 - periodic safety update report single assessment
347. Paediatric Committee (PDCO): 23-26 March 2021
348. 2023-2027 PIC/S Strategic Plan
349. Sovateltide injection 30μg
350. cdsco-desidustatDesidustat
351. 21 CFR 12.105: Examination of record.
352. EMEA-002507-PIP02-19 - paediatric investigation plan
353. What Can AI Learn from Clinical Engineering? Lessons on 'Brittleness'
354. Training session for patients, consumers and healthcare professionals interested in…
355. Talazoparib With Enzalutamide
356. 21 CFR 58.45: Animal supply facilities.
357. PSUSA/00001617/201907 - periodic safety update report single assessment
358. Pharmacovigilance Risk Assessment Committee (PRAC): 30 September - 3 October 2024
359. cdsco-fiasp-2014FIAsP 2014
360. PSUSA/00010425/202308 - periodic safety update report single assessment
361. Advanced therapy medicinal products: regulation and licensing
362. Standards Spotlight: Demystifying Standards: A Journey into New Sterilization Standards
363. Ramatroban tablets 75 mg
364. PSUSA/00010332/202004 - periodic safety update report single assessment
365. Gerrit Johan Schefferlie elected new Chair of EMA Committee for Veterinary Medicinal…
366. Medicinal Products (Prescription and Control of Supply) Regulations 2022 (SI 32/2022)…
367. ema-mavencladMavenclad
368. PSUSA/00010558/202106 - periodic safety update report single assessment
369. 21 CFR 888.3110: Ankle joint metal/polymer semi-constrained cemented prosthesis.
370. PSUSA/00003146/201507 - periodic safety update report single assessment
371. Guideline on clinical investigation of medicinal products in the treatment of epileptic…
372. Empagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin (10mg + 100mg &…
373. Committee for Orphan Medicinal Products (COMP): 5-7 September 2023
374. EMEA-002205-PIP01-17-M04 - paediatric investigation plan
375. MDS - REQ 7: Requirements for Unique Device Identification (UDI) for Medical Devices
376. cdsco-qaw039-on-fev1QAW039 on FEV1
377. Committee for Proprietary Medicinal Products (CPMP) 29th plenary meeting
378. EU/3/13/1152 - orphan designation for treatment of pancreatic cancer
379. ema-clopidogrel-hcsClopidogrel HCS
380. PSUSA/00010225/201710 - periodic safety update report single assessment
381. Committee for Proprietary Medicinal Products (CPMP) 32nd plenary meeting
382. Impact of liver immaturity when investigating medicinal products intended for neonatal use…
383. EU/3/18/2104 - orphan designation for treatment of C3 glomerulopathy
384. PSUSA/00000557/202201 - periodic safety update report single assessment
385. EMEA-000849-PIP01-10-M01 - paediatric investigation plan
386. Confidence Spinal Cement System
387. Gam-COVID-Vac combined vector vaccine Component Iand Component II
388. PSUSA/00000383/202006 - periodic safety update report single assessment
389. PSUSA/00010346/202111 - periodic safety update report single assessment
390. 21 CFR 874.3330: Master hearing aid.
391. ema-previcoxPrevicox
392. EU/3/07/493 - orphan designation for treatment of Gaucher disease
393. cdsco-mino-lok-therapy-mltMino-Lok Therapy (MLT
394. ema-infiniaInfinia
395. Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working…
396. Higher tier testing to investigate the effects of parasiticidal veterinary medicinal…
397. Initial evaluation procedures
398. PSUSA/00002664/202211 - periodic safety update report single assessment
399. EU/3/23/2807 - orphan designation for treatment of malignant mesothelioma
400. EU/3/18/2083 - orphan designation for treatment of graft-versus-host disease
401. cdsco-herceptin-or-tx05Herceptin® or TX05
402. ema-nexgard-spectraNexgard Spectra
403. EMEA-001084-PIP01-10 - paediatric investigation plan
404. PSUSA/00000050/201512 - periodic safety update report single assessment
405. PSUSA/00010000/201412 - periodic safety update report single assessment
406. cdsco-astegolimabASTEGOLIMAB
407. 21 CFR 884.5900: Therapeutic vaginal douche apparatus.
408. Enforcement activities to stop hoarding/back marketing/overcharging of COVID Managment…
409. Paediatric Committee (PDCO): 12-14 January 2011
410. Clinical investigation of medicinal products for long-term use
411. 36th meeting of the Committee for Orphan Medicinal Products
412. Guidance on the management of GMP compliance signals
413. EU/3/22/2639 - orphan designation for treatment of cystic fibrosis
414. cfr-21-cfr-54-3-scope21 CFR 54.3: Scope.
415. ema-committee-highlightsCommittee highlights
416. FDA to Focus on Lowering Ethylene Oxide Emissions
417. Committee for Orphan Medicinal Products (COMP): 6-8 December 2022
418. European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging…
419. Tocilizumab 80mg(rDNA) solution for intravenousinfusion 80mg/4ml vial
420. EMEA-001013-PIP01-10-M01 - paediatric investigation plan
421. cdsco-isoniazidIsoniazid
422. ema-public-health-threatsPublic health threats
423. Apply for a licence to market a medicine in the UK
424. European Agency for the evaluation of medicinal products: Committee for Proprietary…
425. 21 CFR 862.1665: Sodium test system.
426. Drug Alert list for month of January 2019
427. World Health Organization Identifies Top AI Concerns for Regulators
428. EMEA-001741-PIP03-16-M03 - paediatric investigation plan
429. 21 CFR 20.46: Waiver or reduction of fees.
430. Alison Bloomquist: A Simple Solution to Improve Syringe Pump Safety
431. Ribavirin Teva Pharma B.V.
432. ema-newsletter-archiveNewsletter archive
433. EU/3/24/2927 - orphan designation for treatment of arrhythmogenic cardiomyopathy caused by…
434. Quality Working Party questions and answers on API mix - Scientific guideline
435. Statutory advisory committee forms
436. NMPA Announcement on Matters Concerning the Importation of Pre-approval Commercial-Scale…
437. Zoledronic acid Teva Pharma
438. 21 CFR 862.1595: Porphyrins test system.
439. EMEA-002815-PIP01-20 - paediatric investigation plan
440. EMEA-001992-PIP02-16-M01 - paediatric investigation plan
441. EMEA-001501-PIP01-13-M07 - paediatric investigation plan
442. EMEA-001539-PIP01-13-M05 - paediatric investigation plan
443. Gator Tank Winners Aim to Reinvent BMET Talent Management
444. Regulation on Management of Safety Information Including Medical Device Side Effects, Etc
445. 21 CFR 14.70: Administrative record of a public hearing before an advisory committee.
446. EU/3/06/377 - orphan designation for treatment of growth hormone (GH) gene deletion who…
447. EU/3/22/2578 - orphan designation for treatment of amyotrophic lateral sclerosis
448. Assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal…
449. 21 CFR 1.1116: What must a recognized accreditation body do to voluntarily relinquish or…
450. PSUSA/00010236/201701 - periodic safety update report single assessment
451. 21 CFR 866.4750: Automated indirect immunofluorescence microscope and software-assisted…
452. TGA conformity assessment procedures for immunohaematology reagents
453. 21 CFR 870.1340: Catheter introducer.
454. One on One with Horlando Cintron
455. Regulation of import and manufacture of certain medical devices covered under the…
456. Prescription medicine registration form
457. EU/3/18/2049 - orphan designation for treatment of ectonucleotide…
458. 21 CFR 872.3450: Ethylene oxide homopolymer and/or karaya denture adhesive.
459. European Medicines Agency Human Scientific Committees' Working Parties with Patients' and…
460. ema-leqembiLeqembi
461. Fourth European Medicines Agency and European Federation of Pharmaceutical Industries and…
462. Novartis Europharm Ltd. withdraws its application for an extension of indication for…
463. Paediatric Committee (PDCO): 17-19 July 2013
464. Integrating patients' views in clinical studies of anticancer medicines
465. European Medicines Agency publishes booklet on European regulatory system for medicines
466. 21 CFR 860.132: Procedures when the Commissioner initiates a performance standard or…
467. EU/3/23/2768 - orphan designation for treatment of CDKL5 deficiency disorder
468. ema-elleforeEllefore
469. ema-suvaxyn-pcvSuvaxyn PCV
470. Concept Paper on the Revision of Annex 4 of the Guidelines on Good Manufacturing Practice…
471. EMEA-000931-PIP01-10 - paediatric investigation plan
472. Eylea - direct healthcare professional communication (DHPC)
473. New Telehealth Report Rates State Telehealth Policies
474. Drug Alert list for month of September 2021
475. EMEA-003339-PIP01-22 - paediatric investigation plan
476. Standards of Review Fees for the Registration of Western Medicines
477. ema-eklira-genuairEklira Genuair
478. 21 CFR 866.5530: Immunoglobulin G (Fc fragment specific) immunological test system.
479. 21 CFR 884.6190: Assisted reproductive microscopes and microscope accessories.
480. Patient group directions (PGDs)
481. 21 CFR 20.107: Food and Drug Administration manuals.
482. Archived versions of the European Medicines Agency's website
483. European Medicines Agency encourages submission of quality type-I variations by end of…
484. EU/3/19/2181 - orphan designation for treatment of soft tissue sarcoma
485. FDA recommends against the continued use of propoxyphene
486. Nplate and Promacta - Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate…
487. PSUSA/00001711/202107 - periodic safety update report single assessment
488. PSUSA/00001124/201411 - periodic safety update report single assessment
489. Combination: Species pectorales - herbal medicinal product
490. EU/3/14/1398 - orphan designation for treatment of malignant mesothelioma
491. cfr-21-cfr-17-39-evidence21 CFR 17.39: Evidence.
492. Guidance Document: Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid…
493. cdsco-bevacizumabBevacizumab
494. Questions and answers: Article 30 referral procedures
495. How are new medicines approved by EMA?
496. Medical Device Post-Market Surveillance: The 7 Deadly Sins to Avoid
497. International regulators provide guiding principles for COVID-19 clinical trials
498. Herbal medicinal products
499. EMEA brings in new openness measures and acts to encourage development of veterinary…
500. EU/3/16/1753 - orphan designation for treatment of leukocyte adhesion deficiency type I
501. EMEA-001531-PIP01-13-M04 - paediatric investigation plan
502. Singapore-Specific Annex (SSA)
503. Notice regarding Risk based inspections of the manufacturing facilities regarding
504. cdsco-vedolizumabVedolizumab
505. Bempedoic acid 180 mg tabletct
506. EMEA-001237-PIP01-11 - paediatric investigation plan
507. C1 esterase inhibitor (plasma-derived, human)
508. EudraVigilance: how to register
509. 21 CFR 888.3770: Wrist joint carpal trapezium polymer prosthesis.
510. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
511. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 5-7 November 2013
512. Slenyto - opinion on variation to marketing authorisation
513. PSUSA/00000007/201412 - periodic safety update report single assessment
514. ema-protium-referralProtium - referral
515. EU/3/10/831 - orphan designation for treatment of mantle cell lymphoma
516. EMEA-000602-PIP02-12 - paediatric investigation plan
517. Notice inviting comments / Suggestions of Pharma and Medical Device Associations for…
518. Consultation: Cleaning Validation Guidance (GUI-0028)
519. Denosumab Injection 120 mg/1.7 mL (70 mg/mL)
520. Efficacy: veterinary limited markets
521. Advanced therapy medicinal products: Overview
522. EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
523. ema-polysorbatesPolysorbates
524. EU/3/14/1380 - orphan designation for treatment of mucopolysaccharidosis type I
525. emaglutide 2.4 mg CT/18/000019
526. EU/3/12/1093 - orphan designation for treatment of glioma
527. cdsco-evenamide-nw-3509Evenamide(nw-3509)
528. EMEA-001095-PIP03-19 - paediatric investigation plan
529. 21 CFR 4.2: How does FDA define key terms and phrases in this subpart?
530. Drug Safety Update: monthly PDF newsletter: Drug Safety Update October 2021
531. EMEA-001266-PIP04-19 - paediatric investigation plan
532. Medicines: Get integrated scientific advice from the MHRA and NICE
533. EMEA-000160-PIP01-07-M05 - paediatric investigation plan
534. EU/3/08/546 - orphan designation for treatment of congenital alpha-1 antitrypsin…
535. cfr-21-cfr-884-5300-condom21 CFR 884.5300: Condom.
536. PSUSA/00010374/201801 - periodic safety update report single assessment
537. VICH GL6 Environmental impact assessment (EIAS) for veterinary medicinal products - Phase…
538. EU/3/24/2953 - orphan designation for treatment of Prader-Willi syndrome
539. Public Statement on Orlaam (Levacetylmethadol) - Life threatening Ventricular Rhythm…
540. NMPA Issues Announcement on Performing Consistency Evaluation of the Quality and Efficacy…
541. cdsco-july-14-2014-gsr-503-eJuly 14 2014 GSR 503(E)
542. Concept paper for the development of a guideline on the demonstration of therapeutic…
543. 2026.02.02 G.S.R. 97(E)_Draft Notification regarding submission of post approval changes…
544. Flupentixol + Melitracen tablets (Phase IV)
545. EudraVigilance training on the electronic reporting of individual case safety reports…
546. ema-rilutekRilutek
547. ema-invanzInvanz
548. amended Clinical Trial protocol version 1.4 by ICMR dated 2020-04-22_on convalescent…
549. EMEA-003094-PIP02-21 - paediatric investigation plan
550. PSUSA/00003016/201708 - periodic safety update report single assessment
551. ASEAN Guideline for the Conduct of Bioavailability and Bioequivalence Studies
552. With Changes on the Horizon, Mills Charts Path for Meeting TJC Maintenance Requirements
553. EMA Management Board: highlights of June 2023 meeting
554. Risk-analysis approach for residues of VMPs in food of animal origin - Scientific…
555. January 06,2016 GSR 11(E)
556. Committee for Advanced Therapies (CAT): 9-11 August 2023
557. New safety features for medicines sold in the EU
558. Danielle McGeary: To the Class of 2020
559. Second periodic safety update report information day
560. ema-aripiprazole-zentivaAripiprazole Zentiva
561. EMEA-002497-PIP01-18 - paediatric investigation plan
562. EU/3/24/2907 - orphan designation for treatment of Becker muscular dystrophy
563. FDA requires label changes to warn of rare but serious neurologic problems after epidural…
564. 2021.06.22_SO 2449(E)_Notification of 14 Govt Analysts for CDTL Mumbai
565. cdsco-lumateperoneLumateperone
566. Reclassification of active implantable medical devices (AIMD)
567. EU actions to support availability of medicines during COVID-19 pandemic – update #2
568. EU/3/13/1145 - orphan designation for treatment of soft tissue sarcoma
569. AS F0012.1.001: Witnessed Audit Flowchart
570. EU/3/08/527 - orphan designation for treatment of systemic-onset juvenile idiopathic…
571. EU-USA strategic meeting on the future of paediatric medicines
572. EMEA-000311-PIP05-17-M02 - paediatric investigation plan
573. ema-exjadeExjade
574. Vaxzevria (previously COVID-19 Vaccine AstraZeneca) - direct healthcare professional…
575. ema-dovatoDovato
576. European Medicines Agency issues guidance on prevention of HIV transmission for public…
577. Fees payable to the European Medicines Agency
578. PSUSA/00010484/201711 - periodic safety update report single assessment
579. 21 CFR 74.101: FD&C Blue No. 1.
580. Durvalumab plus Olaparib
581. EMEA-001665-PIP01-14-M06 - paediatric investigation plan
582. Info day for micro, small and medium-sized enterprises: supporting innovative medicines'…
583. Mayo Clinic Details Best Practices in the ‘Healthcare Internet of Things’
584. Urticae folium - herbal medicinal product
585. 21 CFR 890.5760: Nonpowered lower extremity pressure wrap.
586. European Union (EU) International Organization for Standardization (ISO) identification of…
587. EU/3/17/1886 - orphan designation for treatment of tuberous sclerosis
588. EMEA-002093-PIP02-17-M01 - paediatric investigation plan
589. 19th meeting of the Committee for Orphan Medicinal Products
590. Vaccines Working Party documents
591. Committee for Advanced Therapies (CAT): 17-18 September 2015
592. EU/3/13/1216 - orphan designation for treatment of progressive familial intrahepatic…
593. 21 CFR 10.45: Court review of final administrative action; exhaustion of administrative…
594. Mifepristone Linepharma - referral
595. Committee for Orphan Medicinal Products (COMP): 18-20 April 2023
596. fda-mddt-face-q-aestheticsFACE-Q | Aesthetics
597. European Medicines Agency appoints new Head of Unit for Veterinary medicines and…
598. European Medicines Agency is consulting on the reflection paper on the use…
599. ema-steqeymaSteqeyma
600. ema-isturisaIsturisa
601. Lasers, intense light source systems and LEDs
602. Committee for Medicinal Products for Human Use (CHMP) Blood Products Working Party (BPWP)…
603. VICH GL48 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in…
604. Antimicrobial-resistance surveillance as post-marketing authorisation commitment…
605. cdsco-imu-838IMU-838
606. PSUSA/00000629/202108 - periodic safety update report single assessment
607. Robert Sayle: Going with the (Analytics) Flow
608. Committee for Advanced Therapies (CAT): 9-11 October 2024
609. PSUSA/00002767/201704 - periodic safety update report single assessment
610. Committee for Medicinal Products for Human Use (CHMP): 16-19 September 2019
611. February 1st 2017 GSR 80(E)
612. Yellow Fever Vaccine (Live) I.P.
613. Drug Alert list for month of December 2017
614. “EMA ready to address challenges ahead”
615. EU/3/15/1492 - orphan designation for treatment of Huntington’s disease
616. 2020.07.27_S.O. 2450(E)_Reg. validity of existing Registration Certificate for import of…
617. Glossary used for the ACTD and ACTR
618. European Medicines Agency explains EU incident management plan for human medicines
619. In Memoriam: Alan Tallentire
620. Committee for Orphan Medicinal Products (COMP): 7-8 April 2010
621. Assessment and procurement of coronavirus (COVID-19) tests
622. Regulatory information - European Medicines Agency publishes guidance on validation…
623. tga-medicinal-gases-guidanceMedicinal gases guidance
624. EMA advice on use of colistin in animals to be updated
625. ema-zesslyZessly
626. Vismodegib product-specific bioequivalence guidance
627. March 30 2017 GSR 302(E)
628. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare…
629. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 February 2020
630. ema-pP
631. Paediatric Committee (PDCO): 10-13 November 2020
632. CDRH Update on Cybersecurity
633. European Medicines Agency Human Scientific Committees' Working Party with Patients' and…
634. 21 CFR 866.5425: Alpha-2-glycoproteins immunological test system.
635. EMEA-002915-PIP01-20-M01 - paediatric investigation plan
636. Daratumumab Concentrate for Solution for Infusion 100mg/5mLVial and 400 mg/20 mL Vial
637. Montelukast Sodium IP eq. to Montelukast + Bilastine orodispersible tablet (Phase III)
638. Paediatric Committee (PDCO): 24-27 April 2018
639. Flurbiprofen Geiser - referral
640. ema-vegzelmaVegzelma
641. Refusal of orphan designation for treatment of epidermolysis bullosa
642. 21 CFR 866.3780: Toxoplasma gondii serological reagents.
643. EMEA-002945-PIP02-21 - paediatric investigation plan
644. EMEA-000530-PIP02-11 - paediatric investigation plan
645. Brexit-related guidance for companies
646. EMA reviewing risk of dosing errors with methotrexate
647. Olezarsen (ISIS 678354)M/s. Medpace Clinical
648. European Medicines Agency annual report for 2006 shows record numbers of applications…
649. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24…
650. Obtaining an EU marketing authorisation, step-by-step
651. 21 CFR 1.514: What are some consequences of failing to comply with the requirements of…
652. Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs)…
653. 21 CFR 866.5110: Antiparietal antibody immunological test system.
654. First workshop for the EMEA/CHMP Working Group with Patients' Organisations
655. Epilepsy medicines and pregnancy
656. DR_G.S.R. 532(E) dt_18.05.2016_Addition of Vishakhapatnam Sea and air port
657. Medical Device Shortages SPOC Working Party meetings
658. cdsco-jan-19-2011-g-s-r-40-eJan 19, 2011 (G.S.R 40 (E))
659. EMEA-001884-PIP03-18 - paediatric investigation plan
660. IRIS for Good Pharmacovigilance practice (GVP) inspections training session for industry…
661. February 2nd 2017 GSR 101(E)
662. Expressions of interest invited for transatlantic workshop on drug-related PML
663. EMEA-002877-PIP01-20 - paediatric investigation plan
664. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo…
665. 21 CFR 862.1045: Aldosterone test system.
666. Provisional determination
667. Central register of data processing records
668. EMEA-001190-PIP01-11 - paediatric investigation plan
669. 21 CFR 862.1290: Fatty acids test system.
670. cdsco-ly3537982LY3537982
671. ema-imraldiImraldi
672. PMDA’s Support to Venture Companies
673. Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to…
674. PSUSA/00001231/202210 - periodic safety update report single assessment
675. EMEA-000864-PIP01-10 - paediatric investigation plan
676. ema-vyeptiVyepti
677. 21 CFR 14.25: Portions of advisory committee meetings.
678. EU/3/13/1109 - orphan designation for treatment of hepatocellular carcinoma
679. 21 CFR 862.3250: Cocaine and cocaine metabolite test system.
680. European Medicines Agency recommends new contraindication and warning for Rasilez and…
681. List of Drugs Medical Devices Vaccine and Cosmetics declared as Spurious for the Month of…
682. Mandatory requirements for an effective application to vary the Permissible Ingredients…
683. Team-NB-MDR-IVDR-Application-201712
684. Testosterone-containing medicines - referral
685. cdsco-pertuzumabPertuzumab
686. EMEA-001274-PIP01-12 - paediatric investigation plan
687. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 May 2017
688. EMEA-002460-PIP01-18 - paediatric investigation plan
689. ema-nobivac-lovo-l4Nobivac LoVo L4
690. August 16, 2016: Microbiology Devices Panel of the Medical Devices Advisory Committee…
691. Overcome the ‘Blame Game’ of Device Connectivity Issues through Strong Staff Connections
692. How Data Sharing Can Promote Patient Safety
693. OSIRIX CDE Software Module
694. European Medicines Agency veterinary medicines info day 2023
695. Training on electronic reporting of individual case safety reports (ICSRs) to…
696. Machine Learning Predicts Prediabetes with Continuous Glucose Monitor Tracking
697. 21 CFR 878.3680: Nose prosthesis.
698. Committee for Proprietary Medicinal Products (CPMP) 54th plenary meeting
699. cdsco-ly3537031LY3537031
700. EMA update on shortages of antibiotics in the EU
701. EMEA-002121-PIP03-19-M01 - paediatric investigation plan
702. Team-NB-List-PositionPapers-20240911
703. EU/3/16/1633 - orphan designation for treatment of gastro-entero-pancreatic neuroendocrine…
704. PSUSA/00002174/201502 - periodic safety update report single assessment
705. FDA Drug Safety Communication: Drug labels now contain updated recommendations on the…
706. PSUSA/00001583/201702 - periodic safety update report single assessment
707. Radioactive Drug Research Committee (PDF - 142KB)
708. UPDATED AGENDA INFORMATION : July 25, 2024 Meeting of the Oncologic Drugs Advisory…
709. Numeta G13%E and Numeta G16%E emulsion for infusion - referral
710. PSUSA/00010199/202105 - periodic safety update report single assessment
711. 2021.08.03_Draft G.S.R. 533(E)_Rule 90, Form 29 Deemed approval
712. EU/3/10/752 - orphan designation for treatment of Gaucher disease
713. 21 CFR 860.90: Consultation with panels.
714. EU/3/14/1412 - orphan designation for treatment of pancreatic cancer
715. EMEA-002244-PIP02-18 - paediatric investigation plan
716. Regulatory information – EMA provides advice notes on pharmacovigilance annual fees
717. Ark Therapeutics Ltd withdraws its marketing authorisation application for Cerepro…
718. 21 CFR 864.2220: Synthetic cell and tissue culture media and components.
719. EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)
720. EMEA-002059-PIP01-16 - paediatric investigation plan
721. Paediatric Committee (PDCO): 7-9 December 2011
722. Committee for Advanced Therapies (CAT): 16-18 October 2013
723. ema-firmagonFirmagon
724. cdsco-rp7214jssRP7214jss
725. cdsco-ly3437943LY3437943
726. EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
727. EMEA/ICH Workshop on Viral/Vector Shedding
728. Pharmacokinetics Working Party
729. Industrial Applications of New Biochemical Technolgy
730. EMEA-002016-PIP04-20 - paediatric investigation plan
731. EU/3/15/1581 - orphan designation for treatment of pyruvate dehydrogenase complex…
732. Committee for Medicinal Products for Human Use (CHMP): 22-25 June 2026
733. Seroquel / Seroquel XR and associated names - referral
734. Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin + Dapagliflozin Propanediol…
735. PSUSA/00002846/202004 - periodic safety update report single assessment
736. Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety…
737. ema-eladynosEladynos
738. 21 CFR 868.5375: Heat and moisture condenser (artificial nose).
739. Committee for Orphan Medicinal Products (COMP): 5-6 December 2012
740. Paediatric Committee (PDCO): 17-20 January 2023
741. PSUSA/00002896/202209 - periodic safety update report single assessment
742. EMEA-002561-PIP02-20 - paediatric investigation plan
743. PSUSA/00002150/201505 - periodic safety update report single assessment
744. cdsco-june-16-2009-g-s-r-355June 16,2009 (G.S.R.355)
745. 21 CFR 58.15: Inspection of a testing facility.
746. EMEA-002299-PIP01-17 - paediatric investigation plan
747. EU/3/19/2225 - orphan designation for treatment of autosomal recessive congenital…
748. The FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict…
749. EMEA-003080-PIP03-22 - paediatric investigation plan
750. Specification and criteria for acceptance for test performed on syphilis raid and ELISA…
751. Merisone and associated names - referral
752. EU/3/09/617 - orphan designation for treatment of beta thalassaemia intermedia and major
753. EU/3/17/1916 - orphan designation for treatment of biliary tract cancer
754. EMEA-002206-PIP02-19 - paediatric investigation plan
755. cdsco-dupilumabrDupilumabr
756. New add-on treatment for patients with severe asthma
757. 21 CFR 878.5400: Low level laser system for aesthetic use
758. Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid…
759. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 March 2021
760. EU/3/17/1951 - orphan designation for treatment of pemphigus
761. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations…
762. cdsco-study-nestStudy (NEST)
763. ema-mimparaMimpara
764. Lansoprazol-ratiopharm 15 mg and 30 mg - referral
765. EMEA-001279-PIP01-12 - paediatric investigation plan
766. Rusci rhizoma - herbal medicinal product
767. Regulations of Medicament Manufacturer Inspection
768. EU/3/14/1299 - orphan designation for treatment of systemic sclerosis
769. EudraVigilance Veterinary
770. cdsco-ribiciclibRibiciclib
771. cdsco-trastuzumab-deruxtecanTrastuzumab Deruxtecan
772. Guidance on determining whether an amendment to a clinical trial is a substantial…
773. ema-mozobilMozobil
774. Committee for Herbal Medicinal Products (HMPC): 3-5 May 2021
775. Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and…
776. 21 CFR 1.715: When must a user fee required by this subpart be submitted?
777. EU/3/20/2386 - orphan designation for treatment of idiopathic hypersomnia
778. 21 CFR 886.5900: Electronic vision aid.
779. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - October 2016
780. EMA starts review of conditional marketing authorisation application for Skycovion…
781. Study Shows AI Model May Be Able to Predict Best Epilepsy Drug for Each Patient
782. ema-vasotop-p-referralVasotop P - referral
783. 21 CFR 866.3945: Dengue virus serological reagents.
784. 2013 annual workshop of the European Network of Paediatric Research at the European…
785. Filgotinib combined phase
786. Committee for Medicinal Products for Human Use (CHMP): 9-12 October 2017
787. EU/3/12/998 - orphan designation for treatment of Wiskott-Aldrich syndrome
788. EU/3/09/653 - orphan designation for treatment of atypical haemolytic uraemic syndrome…
789. EU/3/15/1590 - orphan designation for treatment of Merkel cell carcinoma
790. cdsco-bcd-021BCD-021
791. ema-erbituxErbitux
792. Guideline on registry-based studies - launch of public consultation
793. Adapalene EP + Benzoyl Peroxide EP per gram topical Gel (Phase IV)
794. Paediatric Committee (PDCO): 12-14 November 2014
795. PSUSA/00001713/202212 - periodic safety update report single assessment
796. EU/3/22/2742 - orphan designation for treatment of diffuse large B-cell lymphoma
797. NexoBrid - opinion on variation to marketing authorisation
798. Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540/2007)…
799. First European Medicines Agency - Vaccines Europe meeting
800. PSUSA/00001244/201704 - periodic safety update report single assessment
801. EMEA-003005-PIP01-21 - paediatric investigation plan
802. A Call for Papers on Mobile Health
803. Hydroxyprogesterone caproate - direct healthcare professional communication (DHPC)
804. EU/3/22/2572 - orphan designation for treatment of peripheral T-cell lymphoma
805. EU/3/14/1284 - orphan designation for treatment of invasive aspergillosis
806. EMEA-000306-PIP01-08-M04 - paediatric investigation plan
807. 21 CFR 890.5860: Ultrasound and muscle stimulator.
808. ema-aclastaAclasta
809. Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Cilnidipine IP film coated…
810. 14th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
811. Blue Guide: advertising and promoting medicines: Appendix 4 - Blue Guide
812. Medical Devices Regulations (SOR/98-282)
813. Executive Steering Group on Shortages and Safety of Medicinal Products
814. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June…
815. Committee for medicinal products for veterinary use: Meeting of 8 to 10 November 2005
816. PSUSA/00002235/202108 - periodic safety update report single assessment
817. Big data training curriculum
818. EMEA-001548-PIP01-13 - paediatric investigation plan
819. EU/3/17/1866 - orphan designation for treatment in solid organ transplantation
820. PIC/S Work Plan for 2021
821. EU/3/18/2052 - orphan designation for treatment of primary hyperoxaluria
822. Revision of Notification on Electronic Study Data
823. Management Board meeting: 15 March 2018
824. Azilsartan KamedoxomilChlorthalidone IP tablet
825. Vildagliptin + Metformin Hydrochloride IP Film coated bilayered tablets (Phase III)
826. ema-qizendayQizenday
827. EU/3/08/550 - orphan designation for treatment of pancreatic cancer
828. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
829. EU/3/20/2346 - orphan designation for treatment of GM1 gangliosidosis
830. Regulations for Administration on Human Organ Bank
831. EU/3/17/1917 - orphan designation for treatment of pancreatic cancer
832. GN-33 R1.2 Guidance on the Application of Singapore Standard GDPMDS(2022 Nov)_PUB
833. EMEA-001214-PIP05-19 - paediatric investigation plan
834. Veterinary Focus group Meeting - PK/PD modelling
835. EU/3/08/581 - orphan designation for treatment of chronic lymphocytic leukaemia
836. EU/3/21/2561 - orphan designation for treatment of primary biliary cholangitis
837. Paediatric Committee (PDCO): 26-29 January 2021
838. Public statement - European Medicines Agency announces regulatory action on COX-2…
839. cdsco-adagrasibAdagrasib
840. EMA responds to European Ombudsman
841. FDA Drug Safety Communication: FDA suspends pediatric clinical trials of Sensipar…
842. Cellular, Tissue, and Gene Therapies Advisory Committee June 29-30, 2022 Meeting…
843. Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel…
844. Update of EU recommendations for 2020/2021 seasonal flu vaccine composition
845. Empagliflozin + Linagliptin + Metformin Hydrochloride IP (10mg + 5mg + 1000mg & 25mg + 5mg…
846. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 October 2015
847. PSUSA/00001789/201411 - periodic safety update report single assessment
848. Nominations Open for the 2024 AAMI Awards
849. EMEA-000880-PIP02-11-M04 - paediatric investigation plan
850. Exceptional GMP flexibilities for medicines manufacturers during the coronavirus…
851. FDA Drug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of…
852. 21 CFR 882.5840: Implanted intracerebral/subcortical stimulator for pain relief.
853. AAMI on Air with HTM Podcaster ‘The Bearded Biomed’ and Others
854. Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting…
855. EMEA-001313-PIP01-12-M13 - paediatric investigation plan
856. Opdivo - withdrawal of application for variation to marketing authorisation
857. EMEA-001616-PIP01-13 - paediatric investigation plan
858. PSUSA/00002085/201705 - periodic safety update report single assessment
859. DEHP phthalates in medical devices
860. Tezepelumab or Placebo Solution for injection 110 mg/ mL
861. Clinical investigation of medicinal products for the treatment of Duchenne and Becker…
862. Updated temporary treatment recommendations for Cerezyme
863. Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible…
864. PSUSA/00002681/202010 - periodic safety update report single assessment
865. ema-zepatierZepatier
866. EU/3/09/721 - orphan designation for treatment of Hodgkin's lymphoma
867. cfr-21-cfr-820-3-definitions21 CFR 820.3: Definitions.
868. Clopidogrel Acino Pharma GmbH
869. EU/3/12/1059 - orphan designation for treatment of malignant thymoma
870. Joint European Forum for Good Clinical Practice / Drug Information Association / European…
871. Novartis Europharm Ltd withdraws its marketing-authorisation application for Ruvise…
872. Herbal medicinal products: scientific guidelines
873. 21 CFR 820.80: Receiving, in-process, and finished device acceptance.
874. Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly…
875. Cyberattack on EMA - update 2
876. EU/3/05/320 - orphan designation for treatment of chronic eosinophilic leukaemia and the…
877. ema-lartruvoLartruvo
878. PUBLIC NOTICE Video Conferencing Facility for promotion of innovation & start up business…
879. Public Statement on Sifrol, Daquiran, Mirapexin (Pramipexole) - Recommendation to…
880. Consideration of the directions of Hon'ble Supreme Court in the case of 294 FDCs in…
881. Phil Cogdill: What Do Hiking the Na Pali Coast and Standards Development Have in Common?
882. EU/3/08/576 - orphan designation for treatment of methylmalonic acidaemia
883. Guideline on registry-based studies
884. 21 CFR 890.3665: Congenital hip dislocation abduction splint.
885. ema-enro-k-referralEnro-K - referral
886. ema-ximluciXimluci
887. Biphasic Isophane Insulinm
888. EU/3/18/2056 - orphan designation for treatment of idiopathic pulmonary fibrosis
889. FDA Draft Guidance Addresses Computational Modeling and Simulation Credibility in Medical…
890. ICH Q3B (R2) Impurities in new drug products - Scientific guideline
891. Pneumococcal polysaccharide conjugate vaccine (14-valent)
892. Construction of new EMA building in Amsterdam on track
893. Announcement of "Implementation items and transition periods of the Western…
894. CVMP: meeting archive 2005-2012
895. cdsco-pegozaferminPegozafermin
896. Guidelines on Compounding of Offences under the Drugs and Cosmetics Act, 1940 as per Drugs…
897. Regulations Governing Contract Manufacturing of Medical Devices
898. Pharmacovigilance system (veterinary medicines)
899. cdsco-osimertinibOsimertinib
900. Requirements for quality documentation concerning biological investigational medicinal…
901. 21 CFR 888.1240: AC-powered dynamometer.
902. The Nation is Going Metric (rescinded)
903. Exemption for Certain Clinical Decision Support Software
904. 21 CFR 20.61: Trade secrets and commercial or financial information which is privileged or…
905. ema-iasibonIasibon
906. 21 CFR 1.611: What legal authority must an accreditation body have to qualify for…
907. cdsco-assessment-report-formAssessment report Form
908. Tropicamide 0.2mg + Phenylephrine Hydrochloride IP 3.1mg + Lidocaine Hydrochloride IP 10mg…
909. Favipiravir tablet 800 mg
910. Team-NB MD Sector Survey PressReleas
911. ema-imbarkydImbarkyd
912. cdsco-mirikizumabMirikizumab
913. Leaflet RiskManagement Training 3
914. Recommendation-NB-MED-2_5_1-6_rev4 Renewal of EC Design-Examination and Type-Examination
915. Reflecting on Recent Trends in Cybersecurity
916. EMEA-002444-PIP02-18 - paediatric investigation plan
917. 21 CFR 882.4060: Ventricular cannula.
918. Good pharmacovigilance practices (GVP)
919. cfr-21-cfr-58-3-definitions21 CFR 58.3: Definitions.
920. Esmolol Hydrochloride 14.00% w/w topical gel
921. cdsco-benralizumab-100mgBenralizumab 100mg
922. ema-xeljanzXeljanz
923. Tripartite meeting between EMA, PMDA and FDA on regulatory approaches for the evaluation…
924. PSUSA/00001392/201808 - periodic safety update report single assessment
925. PSUSA/00001454/202202 - periodic safety update report single assessment
926. PSUSA/00003013/201905 - periodic safety update report single assessment
927. 21 CFR 862.1542: Oxalate test system.
928. European Medicines Agency starts review of orlistat-containing medicines
929. cdsco-march-30-2015-so-873-eMarch 30 2015 SO 873(E)
930. PSUSA/00001442/202209 - periodic safety update report single assessment
931. EMEA-001160-PIP01-11-M03 - paediatric investigation plan
932. EMEA-001283-PIP01-12 - paediatric investigation plan
933. Committee for Orphan Medicinal Products (COMP): 7-9 October 2014
934. New measures to avoid valproate exposure in pregnancy endorsed
935. 21 CFR 892.1650: Image-intensified fluoroscopic x-ray system.
936. ema-gutal-referralGutal - referral
937. ema-naglazymeNaglazyme
938. TOPOTECAN AND CYCLOPHOSPHAMIDE
939. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April…
940. Publication of the Regulations Amending the Medical Devices Regulations - Non-Corrective…
941. EMEA-001780-PIP01-15 - paediatric investigation plan
942. EU/3/05/261 - orphan designation for treatment of non-infectious uveitis affecting the…
943. EU/3/05/323 - orphan designation for treatment of malabsorption due to exocrine pancreatic…
944. EU/3/03/140 - orphan designation for treatment of Pseudomonas aeruginosa lung infection in…
945. 21 CFR 14.30: Chairperson of an advisory committee.
946. PSUSA/00001191/202305 - periodic safety update report single assessment
947. FDA Recognizes First AI-Focused Document, AAMI CR34971:2022, in List of Consensus…
948. EMEA-002141-PIP01-17-M03 - paediatric investigation plan
949. 21 CFR 20.91: Use of data or information for administrative or court enforcement action.
950. 21 CFR 862.1155: Human chorionic gonadotropin (HCG) test system.
951. ema-european-union-agenciesEuropean Union agencies
952. Document required for approval of BA-BE center
953. ema-hemaryoHemAryo
954. Abatacept Solution for Injection, 125mg/mL
955. Periodic Safety Update Reports (PSURs) for medicinal products
956. ema-intronaIntronA
957. EU/3/20/2338 - orphan designation for treatment of sickle cell disease
958. EMEA-002880-PIP01-20-M01 - paediatric investigation plan
959. Reporting adverse incidents involving Software as a Medical Device under the vigilance…
960. European Medicines Agency receives second application for human pandemic influenza vaccine
961. EMLA cream and associated names - referral
962. 21 CFR 812.110: Specific responsibilities of investigators.
963. Meeting of the Ad-hoc Executive Steering Group on Shortages and Safety of Medicinal…
964. November 2-3, 2022: Pharmaceutical Science and Clinical Pharmacology Advisory Committee…
965. Committee for Orphan Medicinal Products (COMP):3-4 November 2016
966. Guidance Notes on Good Distribution Practice (GUIDE-MQA-013)
967. cdsco-the-drugs-rules-1945THE DRUGS RULES 1945
968. PSUSA/00010390/201801 - periodic safety update report single assessment
969. EMEA-003085-PIP01-21 - paediatric investigation plan
970. Submission of notarized/ apostilled documents for import and Registration of cosmetics in…
971. PSUSA/00002085/202305 - periodic safety update report single assessment
972. 2018.03.07_Final GSR 76_ Notification of Medical Device Officers (MDO)
973. ema-nucalaNucala
974. PSUSA/00010774/202103 - periodic safety update report single assessment
975. Pharmaceutical development of medicines for use in the older population - Scientific…
976. Leave Travel Concession Bill(Related to Employees)
977. EMEA-001859-PIP02-15 - paediatric investigation plan
978. EMA receives application for marketing authorisation for Ronapreve (casirivimab /…
979. ema-adzynmaAdzynma
980. PSUSA/00003104/202205 - periodic safety update report single assessment
981. 21 CFR 872.6350: Ultraviolet detector.
982. PSUSA/00001552/202007 - periodic safety update report single assessment
983. Vabysmo - direct healthcare professional communication (DHPC)
984. cdsco-clindamycin-tretinoinClindamycin+Tretinoin
985. PSUSA/00001582/201712 - periodic safety update report single assessment
986. 21 CFR 58.219: Reinstatement of a disqualified testing facility.
987. EMA reviewing veterinary medicine Velactis
988. EU/3/17/1915 - orphan designation for treatment of Charcot-Marie-Tooth disease
989. Larry Fennigkoh: Lessons from the Hawaiian Missile Scare
990. EU/3/22/2621 - orphan designation for treatment of hyperphenylalaninaemia
991. Notice-dated 01.10.2012 : Extension of implementations of GSR No. 426(E) dt 19.05.2010
992. International Pharmaceutical Regulators Programme (IPRP)