Global regulations and guidance

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

1. cdsco-ligelizumab-qge031ligelizumab (QGE031)
2. Sacituzumab vedotin (ZRC-3328) 50 mg/ vial
3. cdsco-nifedipine-dagaNifedipine Daga
4. 21 CFR 878.1800: Speculum and accessories.
5. Testing for simian virus 40 (SV40) in polio virus vaccines - Scientific guideline
6. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17…
7. Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication
8. 21 CFR 73.30: Annatto extract.
9. cdsco-deglusterolDEGLUSTEROL
10. ema-insulin-lispro-sanofiInsulin lispro Sanofi
11. 21 CFR 884.4340: Fetal vacuum extractor.
12. 21 CFR 862.1365: Glutathione test system.
13. Batch potency testing of immunological veterinary medicinal product - Scientific guideline
14. Drugs Alert for the month of July 2017
15. Recommendations on labelling and packaging for non-prescription medicines released for…
16. Committee for Advanced Therapies (CAT): 17-19 July 2024
17. cdsco-molnupiravir-moderatenMolnupiravir Moderaten
18. EMEA-002737-PIP01-19 - paediatric investigation plan
19. Legislative Decree No. (21) for the year 2015 On Private Health facilities
20. Duloxetine Hydrochloride eq. to Duloxetine (as delayed release pellets) + Pregabalin IP…
21. cdsco-lnp023nLNP023n
22. Food and Drug Administration / European Medicines Agency orphan-product designation and…
23. PSUSA/00010364/201609 - periodic safety update report single assessment
24. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23…
25. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 July 2017
26. EU/3/21/2548 - orphan designation for treatment of acute myeloid leukaemia
27. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare…
28. EU/3/15/1438 - orphan designation for treatment of adenovirus infection following…
29. European Medicines Agency concludes class review of bisphosphonates and atypical fractures
30. EMEA-002220-PIP01-17 - paediatric investigation plan
31. cdsco-durvalumabDurvalumab
32. PSUSA/00002897/201612 - periodic safety update report single assessment
33. EMEA-001872-PIP02-19 - paediatric investigation plan
34. Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 January…
35. Zanil and associated names, and generic products thereof - referral
36. EU/3/22/2715 - orphan designation for treatment of spinocerebellar ataxia
37. Office Memorandum Nomination of representatives for e-governance
38. AAMI Foundation Seeks Applicants for 2023 Logan Grants
39. Committee for medicinal products for veterinary use: Meeting of 7 - 9 November 2006
40. Early dialogue to support development of medicines for children
41. Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)
42. 21 CFR 14.142: Functions of a color additive advisory committee.
43. cfr-21-cfr-876-4560-ribdam21 CFR 876.4560: Ribdam.
44. 21 CFR 10.65: Meetings and correspondence.
45. Danger in 13 Pixels: ML-Enabled Cyberthreats Inspire Incoming AAMI Consensus Report
46. 21 CFR 862.1265: Estriol test system.
47. 2022 Mary K. Logan Grant Awarded to Novel Sterility Assurance Research
48. EMA press briefing on human medicines highlights in 2023
49. cdsco-larotrectinibLarotrectinib
50. Balsamum peruvianum - herbal medicinal product
51. Fourth small and medium-sized enterprise workshop for micro, small and medium-sized…
52. 21 CFR 884.6195: Assisted Reproduction Embryo Image Assessment System.
53. 21 CFR 1.1450: What procedures apply if FDA tentatively determines that a waiver should be…
54. EU/3/05/312 - orphan designation for treatment of soft tissue sarcoma
55. Basic principles on Utilization of Registry for Applications
56. Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2022
57. 21 CFR 886.4115: Thermal cautery unit.
58. In Vitro Diagnostic roadmap
59. European Medicines Agency boosts EU transparency with online publication of suspected side…
60. Sutent - withdrawal of application for variation to marketing authorisation
61. 21 CFR 60.26: Final action on regulatory review period determinations.
62. EMEA-000635-PIP01-09 - paediatric investigation plan
63. ema-copaliaCopalia
64. PSUSA/00001413/202112 - periodic safety update report single assessment
65. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019
66. EMEA-002618-PIP02-20 - paediatric investigation plan
67. EU/3/08/543 - orphan designation for treatment of amyotrophic lateral sclerosis
68. European Medicines Agency (EMA) / Drug Information Association (DIA) statistics forum: The…
69. EU/3/09/696 - orphan designation for treatment of ovarian cancer
70. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22…
71. EU/3/07/510 - orphan designation for treatment of malaria
72. Blue card adverse reaction reporting form
73. EMEA-000128-PIP02-09-M04 - paediatric investigation plan
74. cdsco-nbtxr3NBTXR3
75. 21 CFR 1.329: Do other statutory provisions and regulations apply?
76. Romiplostim 250µg/0.5mL
77. cfr-21-cfr-19-1-scope21 CFR 19.1: Scope.
78. European Union International Organization for Standardization (ISO) for the identification…
79. EU/3/24/2943 - orphan designation for treatment of hepatocellular carcinoma
80. 21 CFR 884.1100: Endometrial brush.
81. DIA/EFGCP/EMA better medicines for children annual conference
82. Committee for Orphan Medicinal Products: May 2006 meeting
83. ema-rasilamloRasilamlo
84. EMEA-001007-PIP02-15 - paediatric investigation plan
85. October 26-27, 2022: General and Plastic Surgery Devices Panel of the Medical Devices…
86. EMEA-001075-PIP04-15-M06 - paediatric investigation plan
87. ema-porcilis-pestiPorcilis Pesti
88. Core summary for product characteristics for human albumin solution - Scientific guideline
89. DARWIN EU Advisory Board meeting: 6 February 2023
90. Dapagliflozin PC D1699C00001
91. Approval of form in which information sufficient for determination of applications in the…
92. PF-06823859 Solution for Injection, 60 mg per m
93. 21 CFR 26.46: Listing of additional CAB's.
94. EU/3/22/2628 - orphan designation for treatment of gain-of-function mutations of STIM1 and…
95. PSUSA/00002201/201706 - periodic safety update report single assessment
96. 21 CFR 860.5: Confidentiality and use of data and information submitted in connection with…
97. PSUSA/00001583/202002 - periodic safety update report single assessment
98. EMEA-002586-PIP01-19-M01 - paediatric investigation plan
99. EMEA-000052-PIP01-07-M03 - paediatric investigation plan
100. EU/3/17/1852 - orphan designation for treatment in haematopoietic stem cell…
101. Multidisciplinary: nanomedicines
102. Drug Establishment Licence Application Forms and Instructions (FRM-0033)
103. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 12-13 March…
104. Bacterial lysate medicines for respiratory conditions to be used only for prevention of…
105. cdsco-oql011OQL011
106. Additional manufacturing site for COVID-19 Vaccine Janssen
107. Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication
108. European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017…
109. EMEA-003280-PIP01-22 - paediatric investigation plan
110. 21 CFR 74.1705: FD&C Yellow No. 5.
111. Questions and answers on the guideline on the clinical investigation of corticosteroids…
112. Start of review of medicines manufactured at Pharmaceutics International Inc., USA
113. Guidance on the regulation of menstrual cups in Australia
114. COVID-19: developers of medicines or vaccines to benefit from free scientific advice
115. EU/3/06/410 - orphan designation for treatment of soft tissue sarcoma
116. European Medicines Agency recommends measures to manage contamination of…
117. Public consultation open on guideline on the acceptability of names for human medicines
118. Joining Report after EL
119. EMEA-002042-PIP02-20-M01 - paediatric investigation plan
120. 21 CFR 886.1170: Color vision tester.
121. Study: Many Health Apps Pose Data Privacy Risks
122. Procurement activities 2023
123. Requirements for vaccines against foot-and-mouth disease - Scientific guideline
124. Highlighting Important Changes in ANSI/AAMI ST8 and ST24: Two Key Hospital Sterilizer…
125. Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New…
126. EU/3/18/1981 - orphan designation for treatment of hepatocellular carcinoma
127. Notice regarding Draft SOP for handling of NSQ samples
128. EU/3/03/139 - orphan designation for treatment of systemic sclerosis (scleroderma)
129. Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly…
130. PSUSA/00002057/201709 - periodic safety update report single assessment
131. EMEA-002343-PIP01-18 - paediatric investigation plan
132. Classification of Medical Device Pertaining to Interventional Radiology under the…
133. ICH M5 Data elements and standards for drug dictionaries - Scientific guideline
134. 2020.01.27_G.S.R. 52(E) Exemption of Import of Oxytocin reference standards from…
135. Committee for veterinary medicinal products: 71st meeting
136. February 15, 2023: Joint Meeting of the Nonprescription Drugs Advisory Committee and the…
137. cdsco-ranibizumab-brillianceRanibizumab Brilliance
138. 21 CFR 1.75: Animal drugs and veterinary devices.
139. 21 CFR 890.5110: Paraffin bath.
140. PSUSA/00002592/201604 - periodic safety update report single assessment
141. EMEA-001984-PIP02-20-M01 - paediatric investigation plan
142. Committee for Proprietary Medicinal Products (CPMP) 59th plenary meeting
143. Intravenous nicardipine medicines - referral
144. EMEA-001251-PIP01-11-M06 - paediatric investigation plan
145. EMEA-001871-PIP01-15 - paediatric investigation plan
146. EU/3/14/1238 - orphan designation for prevention of delayed graft function after solid…
147. cdsco-trc041266TRC041266
148. 21 CFR 864.3300: Cytocentrifuge.
149. Committee for Orphan Medicinal Products (COMP): 6-8 September 2016
150. EU/3/17/1860 - orphan designation for treatment of ovarian cancer
151. Clinical investigation of medicinal products for the treatment of juvenile idiopathic…
152. Update on review of valsartan medicines following detection of impurity in active…
153. Notice regarding Rational use of antibiotics fro limiting antimicrobial reistance dated…
154. EU/3/08/571 - orphan designation for treatment of atypical haemolytic uraemic syndrome…
155. 21 CFR 876.5160: Urological clamp.
156. European Medicines Agency launches adaptive licensing pilot project
157. Public consultation on a multi-stakeholder platform to improve clinical trials in the EU
158. Approved for Marketing in India
159. PSUSA/00000419/201509 - periodic safety update report single assessment
160. Verify Your Cleaning Methods! Insights from an AAMI Summit
161. EU/3/10/774 - orphan designation for treatment of epidermolysis bullosa
162. Team-NB-MD-Survey-PressRelease-20170413
163. Good Manufacturing Practice (GMP) requirements for medicinal products: PIC/S Guide to GMP…
164. ema-sabumalin-referralSabumalin - referral
165. Management Board meeting: 10 June 2010
166. Brigatinib Tablets 30 mg, 90 mg & 180 mg.
167. cfr-21-cfr-10-3-definitions21 CFR 10.3: Definitions.
168. ema-tasermityTasermity
169. EU/3/15/1535 - orphan designation for treatment of acute radiation syndrome
170. Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and…
171. William Hyman: The FDA Again Addresses Material Specifications
172. Paediatric Committee (PDCO): 11-13 November 2015
173. EU/3/14/1278 - orphan designation for treatment of choroideraemia
174. Notice Order regarding Streamlining the regulatory procedures
175. EU recommendations for 2021-2022 seasonal flu vaccine composition
176. Staying safe when buying medicines online
177. ema-cereniaCerenia
178. PSUSA/00010245/202103 - periodic safety update report single assessment
179. EMEA-001753-PIP02-15 - paediatric investigation plan
180. '100% Certified' Elevates BMET Team
181. 21 CFR 880.6265: Examination gown.
182. Highlights of Management Board: October 2020 meeting
183. Committee for Orphan Medicinal Products: July 2006 meeting
184. Introducing a review and update of existing EU guidelines on residues studies to bring…
185. ema-filsuvezFilsuvez
186. European Medicines Agency and U.S. Food and Drug Administration (FDA) launch Good Clinical…
187. 21 CFR 74.2330: D&C Red No. 30.
188. Reminder to applicants regarding requirements for future eCTD submissions
189. PSUSA/00000210/202208 - periodic safety update report single assessment
190. EMEA-002837-PIP01-20 - paediatric investigation plan
191. 21 CFR 866.3940: West Nile virus serological reagents.
192. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May…
193. April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
194. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
195. ema-dimherityDimherity
196. EMEA-001173-PIP01-11-M01 - paediatric investigation plan
197. Introduction
198. 21 CFR 882.1790: Ocular plethysmograph.
199. EU/3/14/1317 - orphan designation for treatment of diffuse large B-cell lymphoma
200. EU/3/16/1764 - orphan designation for diagnosis of glioma
201. PSUSA/00002589/202307 - periodic safety update report single assessment
202. PSUSA/00000131/201609 - periodic safety update report single assessment
203. cfr-21-cfr-810-2-definitions21 CFR 810.2: Definitions.
204. EU/3/20/2379 - orphan designation for treatment of Angelman syndrome
205. European Medicines Agency issues revised guidance on genotoxicity testing of medicines
206. cdsco-hydrogen-peroxidehydrogen peroxide
207. Good laboratory practice (GLP) facilities: risk-based quality assurance
208. 21 CFR 878.3530: Silicone inflatable breast prosthesis.
209. EMEA-003364-PIP02-22 - paediatric investigation plan
210. Q&A for Stability Guideline on Vaccine
211. 21 CFR 864.6650: Platelet adhesion test.
212. Paediatric Committee (PDCO): 22-25 March 2022
213. Committee for veterinary medicinal products: 69th meeting
214. Tips for Quickly Resolving Issues with ECG Machines
215. Glycopyrroinum Bromide Ph. Eur + Vilanterol Trifenatate inhalation powder
216. Infringement notice - Omega Pharma Limited: Infringement notice - Omega Pharma limited
217. Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014)
218. EU/3/23/2855 - orphan designation for treatment of Prader-Willi syndrome
219. PSUSA/00001842/201610 - periodic safety update report single assessment
220. 21 CFR 1.1154: What other records requirements must a LAAF-accredited laboratory meet?
221. PIC/S GMP Guide (PE 009-17) Part II
222. Thymosin a-1 for Injection 1.6mg
223. ema-ibaflinIbaflin
224. European Medicines Agency to begin PSUR assessment based on active substances in both…
225. PSUSA/00002026/202311 - periodic safety update report single assessment
226. Clinical Trials Information System (CTIS) sponsor end user training programme - June 2024
227. Transparency on AI in Medtech: FDA Accepts Industry Comments
228. Combination: Species sedativae - herbal medicinal product
229. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7…
230. European Medicines Agency excellence in pharmacovigilance: Clinical trials and…
231. Nertrasudil + Latanoprost
232. Committee for Medicinal Products for Human Use (CHMP): 25-28 May 2020
233. EMEA-003239-PIP01-22 - paediatric investigation plan
234. Gadolinium-containing contrast agents - referral
235. EU/3/14/1397 - orphan designation for treatment of Pseudomonas aeruginosa lung infection…
236. 21 CFR 2.25: Grain seed treated with poisonous substances; color identification to prevent…
237. PSUSA/00010354/202305 - periodic safety update report single assessment
238. 21 CFR 82.1330: D&C Red No. 30.
239. EU/3/21/2537 - orphan designation for prevention of bronchopulmonary dysplasia
240. Declaration of the quantitative composition/potency labelling of biological…
241. ema-riensoRienso
242. Requirements for the assessment of medical devices containing animal material
243. Opdivo - withdrawal of application for variation to marketing authorisation
244. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 November…
245. Regulatory information - European Medicines Agency revises rules on fees
246. Committee for Herbal Medicinal Products (HMPC): 19-20 November 2018
247. Consideration of adjuvants and preservatives under Council Regulation (EEC) No 2377/90…
248. EU/3/21/2438 - orphan designation for treatment of marginal zone lymphoma
249. EMEA-002932-PIP02-21 - paediatric investigation plan
250. Notice-27.09.2018_Draft Pharmacovigilance System Inspection Guideline
251. PSUSA/00010651/201805 - periodic safety update report single assessment
252. Typhoid Conjugate Vaccine (Bivalent)
253. 21 CFR 892.5900: X-ray radiation therapy system.
254. La Jolla Limited withdraws its marketing authorisation application for Riquent
255. PSUSA/00002354/201510 - periodic safety update report single assessment
256. Silver, used as an antimicrobial agent
257. (r-hFSH) 900 IU (66.0 μg)/1.5 mL Solution
258. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 April 2020
259. EMEA-001613-PIP01-14-M04 - paediatric investigation plan
260. November 7, 2023: Radiological Devices Panel of the Medical Devices Advisory Committee…
261. November 19, 2026: Microbiology Devices Panel of the Medical Devices Advisory Committee…
262. Committee for medicinal products for veterinary use: Meeting of 17 to 18 May 2005
263. Medicines authorised during pandemic
264. Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes - FDA Safety…
265. 21 CFR 1.233: Are there optional items included in the registration form?
266. PDF version - 504 KB
267. cdsco-pegfilgrastimnPegfilgrastimn
268. EMEA-002743-PIP01-19 - paediatric investigation plan
269. PSUSA/00010199/201505 - periodic safety update report single assessment
270. User safety for immunological veterinary medicinal products - Scientific guideline
271. EU/3/10/731 - orphan designation for treatment of chronic myeloid leukaemia
272. 21 CFR 99.103: Mandatory statements and information.
273. Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events
274. November 20-21, 2024: Digital Health Advisory Committee Meeting Announcement - 11/20/2024
275. William Hyman: Bills in Congress Address Medical Device Safety
276. Clinical Trials Information System (CTIS) bitesize talk: Document and personal data in…
277. This Rehab Robot from Singapore Catches Patients
278. AAMI News, October 2022, Vol.57, No.10
279. Matt Baretich: Seize the Day with New TJC Requirements
280. EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair
281. AAMI News, July 2021, Vol.56, No.7
282. Mpox (monkeypox) tests: Notice to industry
283. 21 CFR 884.6100: Assisted reproduction needles.
284. COVID-19 vaccines approved in the country as on 11.08.2025
285. PSUSA/00001624/201506 - periodic safety update report single assessment
286. 21 CFR 886.5820: Closed-circuit television reading system.
287. PSUSA/00002425/202209 - periodic safety update report single assessment
288. Animal health professionals
289. ema-febuxostat-krkaFebuxostat Krka
290. EMEA-000237-PIP01-08-M10 - paediatric investigation plan
291. 21 CFR 876.4730: Manual gastroenterology-urology surgical instrument and accessories.
292. cdsco-abemaciclibAbemaciclib
293. EMEA-002484-PIP01-18 - paediatric investigation plan
294. PPIs - Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor…
295. August 23 2016 GSR 812(E)
296. Benefits of medicines containing combination of methocarbamol and paracetamol continue to…
297. COVID-19 Vaccine Janssen: EMA recommendation on booster dose
298. Phenazopyridine hydrochloride
299. Appendix 14C Part C: Checklist on Dossier Requirements for MIV-2 (Do-and-tell) Variation…
300. ‘Regulatory science to 2025’: live broadcast of post-consultation workshop on veterinary…
301. cdsco-hgco19HGCO19
302. EU/3/07/487 - orphan designation for treatment of chronic lymphocytic leukaemia
303. ema-procoxProcox
304. EMA and EUnetHTA take stock of their cooperation
305. FDA requires Boxed Warning about serious mental health side effects for asthma and allergy…
306. PSUSA/00001568/201602 - periodic safety update report single assessment
307. ema-docetaxel-mylanDocetaxel Mylan
308. 21 CFR 25.60: Environmental effects abroad of major agency actions.
309. 21 CFR 872.3540: OTC denture cushion or pad.
310. EU/3/03/143 - orphan designation for treatment pancreatic cancer in combination with…
311. ema-supporting-informationSupporting information
312. Committee for medicinal products for veterinary use: Meeting of 11 to 13 May 2004
313. Ad-hoc Management Board meeting on CTIS
314. Annual bulletins on veterinary pharmacovigilance activities (2003-19)
315. cdsco-asciminib-tabletsAsciminib tablets
316. ema-about-usAbout us
317. PSUSA/00010771/201912 - periodic safety update report single assessment
318. EMEA-000225-PIP01-08 - paediatric investigation plan
319. Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with…
320. Paclitaxel-Carboplatin-Oregovomab)
321. cdsco-nnc0194-0499NNC0194-0499
322. 21 CFR 862.3300: Digitoxin test system.
323. EU/3/15/1593 - orphan designation for treatment of myelofibrosis
324. Esomeprazole sodium, Esomeprazole magnesium trihydrate - paediatric investigation plan
325. Committee for Medicinal Products for Human Use (CHMP): 22-25 September 2014
326. EMEA-000904-PIP01-10 - paediatric investigation plan
327. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 June 2017
328. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
329. Environmental risk assessments for medicinal products containing, or consisting of…
330. 21 CFR 1.1345: What records must I keep when I receive a food on the Food Traceability…
331. EU/3/11/923 - orphan designation for treatment of glioma
332. EU/3/20/2373 - orphan designation for treatment of mantle cell lymphoma
333. Pharmaceutical Good Manufacturing Practice Regulations Part 3 Good Manufacturing Practices…
334. EU/3/04/223 - orphan designation for treatment of idiopathic pulmonary fibrosis
335. cdsco-teriparatideTeriparatide
336. Multaq (dronedarone) - Severe liver injury associated with the use of dronedarone…
337. ema-filgrastim-hexalFilgrastim Hexal
338. Clinical trial of convalescent plasma in COVID-19 Patients
339. 21 CFR 870.5900: Thermal regulating system.
340. The Joint Commission’s Herman McKenzie Answers Your Coronavirus Questions
341. NMPA Issues the Announcement on 6 Technical Review Guidances for Registration Including…
342. First Mary K. Logan Grant Recipients Describe Award’s Impact
343. Four more EU Member States benefit from EU-US mutual recognition agreement for inspections
344. PSUSA/00010570/201808 - periodic safety update report single assessment
345. EMEA-001220-PIP08-20 - paediatric investigation plan
346. 21 CFR 870.3545: Ventricular bypass (assist) device.
347. European Medicines Agency's Management Board endorses work programme 2014
348. EU/3/14/1243 - orphan designation for treatment of Farber disease
349. EU/3/22/2623 - orphan designation for treatment of primary IgA nephropathy
350. EU/3/13/1186 - orphan designation for treatment of extranodal marginal-zone lymphoma of…
351. Notification on Handling of In Vitro Diagnostics and Medical Device Products Aiming for…
352. Vaccines and Related Biological Products Advisory Committee April 6, 2022 Meeting…
353. Coordinating investigator signature of clinical study reports - Scientific guideline
354. SAMR Issued the Measures for the Administration of Imported Medicinal Materials
355. EU/3/12/1026 - orphan designation for treatment of calciphylaxis
356. PSUSA/00001907/202202 - periodic safety update report single assessment
357. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
358. ema-cervarixCervarix
359. PSUSA/00000275/201812 - periodic safety update report single assessment
360. 21 CFR 803.32: If I am a user facility, what information must I submit in my individual…
361. Guide on methodological standards in pharmacoepidemiology revised to include…
362. EU/3/06/423 - orphan designation for treatment of congenital ichthyoses
363. Advanced therapies: post-authorisation
364. EU/3/17/1898 - orphan designation for treatment of Wilson's disease
365. Cabazitaxel Accord - direct healthcare professional communication (DHPC)
366. EU/3/18/2097 - orphan designation for treatment of glioma
367. PSUSA/00002487/202401 - periodic safety update report single assessment
368. Medicines for older people
369. 21 CFR 1.1350: What records must I keep when I transform a food on the Food Traceability…
370. 21 CFR 892.5725: Absorbable perirectal spacer.
371. 21 CFR 862.2120: Continuous glucose monitor data management system.
372. Dimethyl fumarate Neuraxpharm
373. EMEA-000493-PIP01-08-M01 - paediatric investigation plan
374. European Medicines Agency and European Food Safety Authority commit to greater…
375. ema-dany-s-bienenwohlDany's BienenWohl
376. Quality aspects on the isolation of candidate influenza vaccine viruses in cell culture…
377. PSUSA/00010353/201605 - periodic safety update report single assessment
378. EMEA-000903-PIP01-10 - paediatric investigation plan
379. EMEA-002795-PIP01-20 - paediatric investigation plan
380. EMEA-001042-PIP02-11 - paediatric investigation plan
381. EMEA-002321-PIP01-17 - paediatric investigation plan
382. ISTA Pharma Ltd withdraws its marketing authorisation application for Vitragan
383. European Medicines Agency's Scientific Coordination Board starts reflection on best…
384. ema-temozolomide-hexalTemozolomide Hexal
385. Paediatric Committee (PDCO): 21-24 July 2020
386. PSUSA/00010734/202111 - periodic safety update report single assessment
387. Assessment of the risk of transmission of animal spongiform encephalopathy agents by…
388. 21 CFR 20.119: Lists of names and addresses.
389. EU/3/19/2241 - orphan designation for treatment of Fabry disease
390. EMEA-002370-PIP01-18 - paediatric investigation plan
391. European Medicines Agency/European Federation of Pharmaceutical Industries and…
392. Paediatric Committee (PDCO): 6-8 February 2013
393. Paediatric Committee (PDCO): 13-16 October 2020
394. Pharmacovigilance Risk Assessment Committee (PRAC): 1-4 October 2018
395. Menthae piperitae aetheroleum - herbal medicinal product
396. PSUSA/00010570/201902 - periodic safety update report single assessment
397. PSUSA/00010437/201804 - periodic safety update report single assessment
398. Drug Alert list for July, 2018
399. Clinical investigations in Great Britain
400. 21 CFR 864.8500: Lymphocyte separation medium.
401. Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation…
402. PRAC starts review of topiramate use in pregnancy and women of childbearing potential
403. ema-strangvacStrangvac
404. Metformin Hydrochloride IP (as extended release) + Dapagliflozin + Teneligliptin…
405. "Datopotamab Deruxtecan (DS- 1062a) Lyophilised powder for concentrate for solution for…
406. Joint HMA/EMA workshop on artificial intelligence in medicines regulation
407. EU/3/21/2465 - orphan designation for treatment of growth hormone deficiency
408. ema-spedraSpedra
409. Medicinal Products (Control of Manufacture) Regulations 2007 (Amendment) Regulations 2009…
410. Transition to paperless (digital) access for unapproved therapeutic goods
411. Priority applicant guidelines for medical devices (including IVDs)
412. cdsco-finerenoneFinerenone
413. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course
414. 21 CFR 26.8: Other transition activities.
415. PSUSA/00001270/202204 - periodic safety update report single assessment
416. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 November 2016
417. Fluoroquinolones - direct healthcare professional communication (DHPC)
418. EMEA-002730-PIP04-21-M01 - paediatric investigation plan
419. Refusal of orphan designation for treatment of retinopathy of prematurity
420. EMEA-002772-PIP01-20 - paediatric investigation plan
421. EU/3/10/844 - orphan designation for treatment of renal-cell carcinoma
422. Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results: FDA…
423. EU/3/22/2594 - orphan designation for treatment of argininosuccinic aciduria
424. ICMRA high-level meeting on global health emergencies and regulatory approaches
425. Joint EMEA(NRG)/EFPIA Workshop on Invented Names
426. EMEA-001276-PIP01-12-M02 - paediatric investigation plan
427. EU/3/19/2207 - orphan designation for treatment of soft tissue sarcoma
428. Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 June 2014
429. ema-kyprolisKyprolis
430. ema-ibandronic-acid-hexalIbandronic Acid Hexal
431. eXtended EudraVigilance Medicinal Product Dictionary training course
432. World Veterinary Day 2014 – focus on animal welfare
433. Expert workshop on process validation for the manufacture of biotechnology-derived active…
434. ema-ammonapsAmmonaps
435. European Medicines Agency launches public consultation on rules of procedures for public…
436. Criteria for determining that an active substance is essential when considered in the…
437. EMEA-002966-PIP01-21 - paediatric investigation plan
438. EU/3/01/037 - orphan designation for treatment of multiple myeloma
439. European Communities (Medical Devices) (Amendment) Regulations 2001 (SI 444/2001) [Active…
440. EU/3/20/2350 - orphan designation for treatment of hypoparathyroidism
441. EMEA-000962-PIP01-10 - paediatric investigation plan
442. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 14-16 September…
443. Core summary of product characteristics for plasma-derived fibrin sealant/haemostatic…
444. Career Center: Transitions are Exciting—And Scary
445. Cancellation of Cosmetics Registration certificate No. RC/Cos-000107 M/s Aurelia…
446. Committee for Orphan Medicinal Products (COMP): 12-13 June 2012
447. 21 CFR 882.1570: Powered direct-contact temperature measurement device.
448. cdsco-tezepelumabTezepelumab
449. Solithromycin Triskel EU Services
450. Re-establishment of working seeds and working cell banks using TSE compliant materials…
451. cdsco-medi3506MEDI3506
452. cdsco-dapagliflozin-10mgDapagliflozin 10mg
453. 21 CFR 892.5050: Medical charged-particle radiation therapy system.
454. EU/3/17/1939 - orphan designation for treatment in solid organ transplantation
455. Recommendations for use of aminoglycosides in animals to reduce risk of antimicrobial…
456. Paediatric Committee (PDCO): 10-13 October 2023
457. EMEA-002350-PIP01-18-M02 - paediatric investigation plan
458. FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain
459. Visudyne - direct healthcare professional communication (DHPC)
460. Software development companies invited to express interest in workshop on electronic…
461. PSUSA/00001781/202001 - periodic safety update report single assessment
462. Health-ISAC Surveys Cyber and Health IT Pros
463. Jardiance - opinion on variation to marketing authorisation
464. ema-closantel-referralClosantel - referral
465. ema-kadcylaKadcyla
466. 21 CFR 872.3590: Preformed plastic denture tooth.
467. Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
468. ema-prokanazol-referralProkanazol - referral
469. EU/3/18/2038 - orphan designation for treatment of multiple osteochondromas
470. European Medicines Agency recommends lifting of suspension for Viracept
471. Terlipressin-containing medicinal products indicated in the treatment of hepatorenal…
472. EMEA-001454-PIP05-18 - paediatric investigation plan
473. Micah Bongberg: What Can Amazon Teach Us About AEDs?
474. European Medicines Agency information day on risk management planning: implementation of…
475. EMA regular press briefing on public health emergencies
476. Medicines: notes for applicants and holders of a manufacturer licence
477. EMEA-001930-PIP01-16-M04 - paediatric investigation plan
478. Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ…
479. ema-porcilis-pcvPorcilis PCV
480. Points to Consider for Evaluation of Efficacy and Safety Using Information Collected as…
481. EU/3/20/2327 - orphan designation for treatment of diffuse large B-cell lymphoma
482. International Women’s Day 2023: #EmbraceEquity: Harriet Teare, Regulatory Science…
483. 21 CFR 892.1740: Tomographic x-ray system.
484. ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human…
485. EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome
486. Metformin Hydrochloride + Doxycycline Hyclate gel (Phase II)
487. Warning statements for labels and leaflets of certain medicines: Additional warning…
488. PSUSA/00001184/201912 - periodic safety update report single assessment
489. Agrimoniae herba - herbal medicinal product
490. PSUSA/00000266/201710 - periodic safety update report single assessment
491. 21 CFR 82.1333: D&C Red No. 33.
492. Notice - clarification and requirements related to post approval changes as per CDSCO…
493. EMEA-001535-PIP01-13-M01 - paediatric investigation plan
494. EMEA-003169-PIP01-21 - paediatric investigation plan
495. 21 CFR 73.1125: Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).
496. Nulojix - direct healthcare professional communication (DHPC)
497. PSUSA/00010560/201804 - periodic safety update report single assessment
498. PSUSA/00010465/201912 - periodic safety update report single assessment
499. Fluticasone Furoate + Umeclidinium Bromide + Vilanterol Trifenatate powder for inhalation…
500. 21 CFR 868.5915: Manual emergency ventilator.
501. EU/3/10/793 - orphan designation for treatment of Friedreich's ataxia
502. Standards of Medical Device Good Manufacturing Practices
503. European Union (EU) International Organisation for Standardization (ISO) for…
504. cdsco-relamorelinRelamorelin
505. EMEA-001642-PIP02-20 - paediatric investigation plan
506. Carvykti - opinion on variation to marketing authorisation
507. ema-movymiaMovymia
508. EU/3/21/2451 - orphan designation for treatment of essential thrombocythaemia
509. EU/3/23/2877 - orphan designation for treatment of amyotrophic lateral sclerosis
510. 1. Mirikizumab 300 mg/15 mL (20 mg/mL) solution for infusion in a single-dose vial 2…
511. ema-vekaciaVekacia
512. Meeting highlights from the Committee for Medicinal Products for Human Use, 20-23 April…
513. Comments invited on guidance on clinical investigation of medicines for the treatment of…
514. Committee for Advanced Therapies (CAT): 6-8 December 2023
515. Online application for Neutral Code for manufacturing of Medical Devices for export…
516. 2019.02.04_Draft GSR 87(E)_Exqmption of State Central Govt testing labs from NABL…
517. ema-kytril-referralKytril - referral
518. EMEA-001164-PIP01-11-M06 - paediatric investigation plan
519. PSUSA/00001638/202104 - periodic safety update report single assessment
520. EMA raises awareness of clinical care recommendations to manage suspected thrombosis with…
521. Exemptions to labelling and package-leaflet obligations
522. EU/3/06/421 - orphan designation for treatment of acute lymphoblastic leukaemia
523. PSUSA/00010510/201701 - periodic safety update report single assessment
524. 21 CFR 862.1678: Tacrolimus test system.
525. EMEA-002268-PIP01-17 - paediatric investigation plan
526. ema-ruconestRuconest
527. ema-xenletaXenleta
528. (Appendix 6) The Standards for Marketing Approval of Laxatives
529. EMEA-000646-PIP01-09-M01 - paediatric investigation plan
530. Pholcodine - direct healthcare professional communication (DHPC)
531. cdsco-office-memorandumOffice Memorandum
532. PSUSA/00002165/201506 - periodic safety update report single assessment
533. 21 CFR 862.3360: Drug metabolizing enzyme genotyping system.
534. Highlights of Management Board: June 2020 meeting
535. European Medicines Agency closed 23 December 2016 to 2 January 2017
536. EU/3/14/1354 - orphan designation for treatment of chronic lymphocytic leukaemia / small…
537. PSUSA/00002411/201603 - periodic safety update report single assessment
538. 21 CFR 872.3690: Tooth shade resin material.
539. NMPA and NHC Jointly Issued the Announcement on Regulations for the Administration of Drug…
540. cdsco-xevinapantxevinapant
541. Computer Aided Detection Software for Intestinal Polyps in Lower Gastrointestinal…
542. ema-mounjaroMounjaro
543. Operational Information Sharing
544. EU/3/15/1487 - orphan designation for treatment of plasma cell myeloma
545. Handling of Influenza Vaccines Manufactured Using Strains Other than Those Dispensed by…
546. Clinical investigation of medicinal products used in the treatment of osteoarthritis…
547. ema-mycograbMycograb
548. Low Acid Canned Food Manufacturers Part 1 - Adminstrative Procedures/Scheduled Processes
549. European Union regulatory workshop on medication errors
550. 21 CFR 82.706: FD&C Yellow No. 6.
551. cdsco-bi-690517BI 690517
552. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
553. cdsco-noticeNotice
554. Budesonide IP 200mcg + Glycopyrronium Bromide eq. to Glycopyrronium 12.5mcg + Formoterol…
555. Medicinal Products (Prescription and Control of Supply) (Amendment) (No 6) Regulations…
556. EMEA-001613-PIP02-20 - paediatric investigation plan
557. ema-ethirfin-referralEthirfin - referral
558. EMEA Management Board adopts the 2007 work programme and budget
559. 21 CFR 1.631: How will FDA review my application for recognition or renewal of recognition…
560. EU/3/22/2697 - orphan designation for treatment of apolipoprotein L1-mediated kidney…
561. Clinical Trials Information System (CTIS): Information day
562. 2021.10.27_Final GSR 762(E) reg Oxytocin API import exclusivelyfor mfg for export purpose…
563. Guidance on medical device compliance and enforcement (GUI-0073)
564. Fesoteroduine Fumarate Extend release tabklet 4 mg/8 mg and Solifenacin sucinate tablets 5…
565. Linoladiol N and Linoladiol HN - referral
566. EMEA-001366-PIP01-12-M02 - paediatric investigation plan
567. FDA Budget Request for 2023 Contains Increase for Medical Device Program
568. Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics
569. EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
570. TEAM-NB List of on line check for validity of certificates
571. EMEA-000395-PIP01-08 - paediatric investigation plan
572. Blue Guide: advertising and promoting medicines: Appendix 1 - Blue Guide
573. Revised public statement on Enbrel (etanercept) - Serious haematological reactions
574. Pharmacogenetics briefing meeting - Scientific guideline
575. Notice regarding List of Reference Products for conduct of BE Study
576. Procedure to be followed for subsequnt applicants in respect of FDCs falling under…
577. Sambuci fructus - herbal medicinal product
578. Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary…
579. ema-avian-influenza-bird-fluAvian influenza (bird flu)
580. 21 CFR 886.4750: Ophthalmic eye shield.
581. PSUSA/00010791/202106 - periodic safety update report single assessment
582. Levetiracetam Actavis Group
583. PSUSA/00002126/202202 - periodic safety update report single assessment
584. AAMI News, November 2022, Vol.57, No.11
585. 21 CFR 81.1: Provisional lists of color additives.
586. EMEA-000515-PIP01-08 - paediatric investigation plan
587. Linezolid (Zyvox) - Serious CNS reactions possible when linezolid (Zyvox) is given to…
588. The Application of IEC 62304 for AI and Other Technologies: It’s Not Rocket Science, It’s…
589. ema-atrianceAtriance
590. VICH GL40 Test procedures and acceptance criteria for new biotechnological/biological…
591. PSUSA/00010299/201504 - periodic safety update report single assessment
592. cdsco-skb264-2870SKB264 2870
593. How to prepare and review a summary of product characteristics
594. EU/3/15/1506 - orphan designation for prevention of scarring post glaucoma filtration…
595. NMPA Announcement on the Issuance of Five Guidelines for Technical Review of the…
596. Cancellous Bone Screws (A Component of the Hip System)
597. Clinical investigation of medicinal products in the treatment of epileptic disorders…
598. Ranibizumab Solution for Injection, 10 mg/mL vial
599. 21 CFR 880.6140: Medical chair and table.
600. ema-cea-scanCEA-Scan
601. EMEA-003341-PIP01-22 - paediatric investigation plan
602. Risk-Adapted Approach to clinical trials and Risk Assessments
603. S.O. 1717(E) dt 15.04.2025_Restriction of the Fixed Dose Combination of Chlorpheniramine…
604. European Medicines Agency announces recall of Viracept
605. Docetaxel Zentiva (previously Docetaxel Winthrop) - withdrawal of application for…
606. EMA takes further steps to address critical shortages of medicines in the EU
607. EU/3/13/1159 - orphan designation for treatment of follicular lymphoma
608. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 5-7 May 2015
609. EU/3/22/2656 - orphan designation for treatment of diffuse large B-cell lymphoma
610. EU/3/09/631 - orphan designation for treatment of glioma
611. ema-namusclaNamuscla
612. Transfer of MA: Regulatory and procedural guidance
613. Intrinsa - withdrawal of application for variation to marketing authorisation
614. EU/3/22/2716 - orphan designation for treatment of C3 glomerulopathy with or without…
615. 21 CFR 17.11: Default upon failure to file an answer.
616. EMEA-002807-PIP01-20-M01 - paediatric investigation plan
617. EMEA-002087-PIP01-16-M01 - paediatric investigation plan
618. 2012.11.30_S.O. 2808(E)_Notification of GA of CDTL Mumbai
619. Interpretation of Article 18(7) of Regulation (EU) 2019/6 - Scientific guideline
620. 21 CFR 74.2304: FD&C Red No. 4.
621. 21 CFR 74.1321: D&C Red No. 21.
622. 21 CFR 73.1: Diluents in color additive mixtures for food use exempt from certification.
623. cdsco-fitusiran-prophylaxisfitusiran prophylaxis
624. 21 CFR 14.145: Procedures of a color additive advisory committee.
625. EMEA-000662-PIP02-09-M05 - paediatric investigation plan
626. Revise list drug alert May-2025
627. Pegylated interferon alfa-2b Cadila
628. PSUSA/00001519/201801 - periodic safety update report single assessment
629. EU/3/05/265 - orphan designation for treatment of graft rejection after lung…
630. EMA Management Board: highlights of December 2016 meeting
631. Medicinal Oxygen Air Liquide Sante
632. EMEA-001971-PIP03-18-M02 - paediatric investigation plan
633. PSUSA/00000051/201610 - periodic safety update report single assessment
634. Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an…
635. Requirements for an authorisation under exceptional circumstances for vaccines for use in…
636. RD-ACTION / EMA / DG SANTE workshop: how European Reference Networks can add value to…
637. EMEA-001813-PIP01-15 - paediatric investigation plan
638. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
639. ema-promeris-duoProMeris Duo
640. Entrectinib Capsules 100mg and 200mg
641. EU/3/17/1942 - orphan designation for treatment of peripheral T-cell lymphoma
642. 21 CFR 888.3550: Knee joint patellofemorotibial polymer/metal/metal constrained cemented…
643. Paediatric Committee (PDCO): 18-20 June 2014
644. Medicine shortages and availability issues: guidance for companies
645. European Medicines Agency publishes second work package of benefit-risk methodology…
646. 21 CFR 1.640: Who is eligible to seek accreditation?
647. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
648. ICH M4S Common technical document for the registration of pharmaceuticals for human use…
649. 2019.03.06_Draft G.S.R.187(E)_Amendment in Form 45 and Form 46 under Schedule-A of D&C…
650. Infrastructure procedures
651. 21 CFR 1.1315: What traceability plan must I have for foods on the Food Traceability List…
652. 21 CFR 862.3: Effective dates of requirement for premarket approval.
653. PSUSA/00003162/202201 - periodic safety update report single assessment
654. 21 CFR 878.4820: Surgical instrument motors and accessories/attachments.
655. 21 CFR 892.1100: Scintillation (gamma) camera.
656. ema-lumiganLumigan
657. PSUSA/00010067/201810 - periodic safety update report single assessment
658. January 9, 2023: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting - 01/09/2023
659. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July…
660. Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2019
661. Just Say ‘No!’ to Insecure Medical Equipment
662. NMPA Announcement on Issuing the Catalogue of Distribution of Class II Medical Devices…
663. Industry Standing Group meetings
664. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - November 2015
665. Glycopyrronium Bromide (Eq. to 50mcg of Glycopyrronium) (63mcg) + Vilanterol Trifenatate…
666. Information and Q&A session on updated CAPs in web-based eAF
667. European Medicines Agency Human Scientific Committees' Working Party with Patients' and…
668. Reporting complaints about health products
669. Ethylene Oxide Sterilizer Standard Updated to Reflect Technological Changes
670. EMEA-002296-PIP01-17-M03 - paediatric investigation plan
671. ema-mock-ups-and-specimensMock-ups and specimens
672. ema-invegaInvega
673. Committee for Orphan Medicinal Products (COMP): 5-7 October 2021
674. Algorithms and the Future of Sterility Assurance
675. ema-canigen-l4Canigen L4
676. Updating an existing Class 1-3 in-house IVD notification
677. 21 CFR 878.4371: Irrigating wound retractor device.
678. EMEA-002034-PIP01-16 - paediatric investigation plan
679. Good manufacturing practices guide for drug products (GUI-0001)
680. Issuance of Certificates for Medical Devices for Export
681. Nor-Ursodeoxycholic Acid 1500mg
682. New medicine to treat heart failure recommended for approval
683. European Medicines Agency recommends transfer of manufacturing sites for Caelyx and…
684. EU/3/13/1116 - orphan designation for treatment of Churg-Strauss syndrome
685. PSUSA/00000048/201806 - periodic safety update report single assessment
686. New Sterility Assurance Strategies for Products Sensitive to Sterilization Processes
687. ema-exforge-hctExforge HCT
688. Clinical investigation of plasma-derived fibrin sealant/haemostatic products - Scientific…
689. EU/3/16/1786 - orphan designation for treatment of aromatic L-amino acid decarboxylase…
690. TGA business plan 2022-23
691. 21 CFR 862.2170: Micro chemistry analyzer for clinical use.
692. Oxynal Targin and associated names - referral
693. GN-02-R6 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2024 Nov)…
694. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
695. NMPA Issues the Requirements for Registration Classification and Application Dossiers of…
696. cdsco-abl001-asciminibABL001 (Asciminib)
697. ema-mepactMepact
698. Artificial Lens Approved for Marketing
699. EU/3/09/705 - orphan designation for treatment of pneumonia caused by serotype O1…
700. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
701. EMA/CAT and Medical Devices Notified Body (EMA/CAT-NB) Collaboration Group
702. PSUSA/00000742/202108 - periodic safety update report single assessment
703. PSUSA/00002433/202110 - periodic safety update report single assessment
704. Committee for Herbal Medicinal Products (HMPC): 14-15 July 2010
705. EU/3/18/2080 - orphan designation for treatment of haemophilia B
706. EU/3/23/2888 - orphan designation for treatment of mucopolysaccharidosis type IIIA…
707. EU/3/01/057 - orphan designation for treatment of acute lung Injury
708. 21 CFR 20.30: Food and Drug Administration Division of Freedom of Information.
709. EU/3/09/616 - orphan designation for treatment of amyotrophic lateral sclerosis
710. 21 CFR 892.1750: Computed tomography x-ray system.
711. Clinical investigation of medicinal products in the treatment of chronic heart failure…
712. Alert on Pholcodine containing cough and cold remedies
713. EU/3/18/2023 - orphan designation for treatment of glioma
714. EMEA-001949-PIP01-16-M05 - paediatric investigation plan
715. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5…
716. 21 CFR 862.2500: Enzyme analyzer for clinical use.
717. MIV Checklist for Class 2 CTGTP
718. ema-zabdenoZabdeno
719. October 25-26, 2016: Technical Electronic Product Radiation Safety Standards Committee…
720. PSUSA/00001855/201905 - periodic safety update report single assessment
721. Form MD-16 Specimen proforma for Medical Devices
722. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - February…
723. Meeting through WebEx Video-conference of the DTAB-sub Committee on 05.04.2024 at 11.00…
724. ema-keeping-medicines-safeKeeping medicines safe
725. Standards Spotlight: Preparation Begins as FDA Shifts Focus to Quality Management Systems…
726. Astellas Pharma Europe B.V. withdraws its application for an extension of the indication…
727. CVMP interested parties' meeting
728. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 February 2013
729. 21 CFR 872.5550: Teething ring.
730. 21 CFR 17.43: Posthearing briefs.
731. ema-rekovelleRekovelle
732. 21 CFR 1.654: When must an accredited third-party certification body monitor an eligible…
733. Tenkasi (previously Orbactiv)
734. EU/3/21/2553 - orphan designation for treatment of spinocerebellar ataxia
735. EMEA-001266-PIP01-12 - paediatric investigation plan
736. Postmarketing Adverse Drug Experience (PADE) Reporting Inspections
737. cdsco-etrolizumabEtrolizumab
738. Notice regarding export NOC with respect to shipping Bills from the Port offices
739. EU/3/17/1871 - orphan designation for treatment of acute myeloid leukaemia
740. Loeglitazone sulphate 0.5 mg tablets
741. ema-lactoseLactose
742. DARWIN EU Advisory Board meeting: 12 November 2021
743. 21 CFR 14.31: Consultation by an advisory committee with other persons.
744. FDA requests removal of strongest warning against using cholesterol-lowering statins…
745. ema-norfloxacin-referralNorfloxacin - referral
746. EMA/235643/2017 - periodic safety update report single assessment
747. SSRI - Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy…
748. European Medicines Agency responds to concerns on its publication of clinical trial data…
749. EMEA-001320-PIP01-12 - paediatric investigation plan
750. EU/3/21/2528 - orphan designation for treatment of amyotrophic lateral sclerosis
751. Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG
752. Brilique - withdrawal of application for variation to marketing authorisation
753. Human medicines: highlights of 2017
754. cdsco-sibeprenlimabSibeprenlimab
755. cdsco-alt-803-n-803ALT-803 (N-803)
756. cdsco-hexavalent-vaccineHexavalent Vaccine
757. PSUSA/00001855/202205 - periodic safety update report single assessment
758. ema-pexionPexion
759. EU/3/10/780 - orphan designation for treatment of chronic lymphocytic leukaemia
760. Daily Updation of No. of Batches of Cough syrup sample for Export at Different…
761. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical…
762. 21 CFR 868.1575: Gas collection vessel.
763. 21 CFR 12.93: Summary decisions.
764. Bioresorbable Rapamycin Target Eluting Coronary Scaffold System Approved for Marketing
765. EU/3/20/2312 - orphan designation for treatment of acute liver failure
766. Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies…
767. Pharmacovigilance Risk Assessment Committee (PRAC): 28 - 31 October 2024
768. mhra-project-orbisProject Orbis
769. EMEA-003323-PIP01-22 - paediatric investigation plan
770. PSUSA/00010442/202001 - periodic safety update report single assessment
771. PSUSA/00002786/201603 - periodic safety update report single assessment
772. Dexamethasone - paediatric investigation plan
773. EU/3/12/994 - orphan designation for treatment of soft tissue sarcoma
774. Dydrogesterone Sustained Release Tablet 20mgCT/SND/13/2023
775. CHMP recommends first oral-only treatment for sleeping sickness
776. cdsco-oxytocin-drug-alertOxytocin Drug Alert
777. SME office: outcomes of seven years of active support to small and medium-size businesses
778. ema-odefseyOdefsey
779. Imfinzi - opinion on variation to marketing authorisation
780. ema-arsenic-trioxide-accordArsenic trioxide Accord
781. Regulatory information – adjusted fees for pharmacovigilance applications to EMA from 12…
782. 21 CFR 872.5410: Orthodontic appliance and accessories.
783. Paulliniae semen - herbal medicinal product
784. cdsco-liraglutide-6-0-mg-mlLiraglutide, 6.0 mg/ml
785. 21 CFR 82.304: FD&C Red No. 4.
786. EMEA-000998-PIP01-10 - paediatric investigation plan
787. PSUSA/00000260/201409 - periodic safety update report single assessment
788. 21 CFR 866.3060: Blastomyces dermatitidis serological reagents.
789. EMEA-002418-PIP01-18-M02 - paediatric investigation plan
790. PSUSA/00010710/202101 - periodic safety update report single assessment
791. Cegfila (previously Pegfilgrastim Mundipharma)
792. cdsco-tegoprazanTegoprazan
793. 21 CFR 20.40: Filing a request for records.
794. ema-yelloxYellox
795. EMEA-001544-PIP01-13-M02 - paediatric investigation plan
796. Recombinant L-Asparaginase-II. (Lyophilized Recombinant L-asparaginase -II for Injection…
797. Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 June 2023
798. Real time release testing - Scientific guideline
799. PSUSA/00000236/201910 - periodic safety update report single assessment
800. European Medicines Agency sees no safety concerns with the Rotarix oral vaccine
801. cdsco-pertuzumabPertuzumab
802. cdsco-amivantamabAmivantamab
803. Tecentriq - opinion on variation to marketing authorisation
804. 21 CFR 866.3340: Klebsiella spp. serological reagents.
805. Teriparatide 20microgram/80 micro litre solution for injection in prefilled pen
806. cdsco-tirzepatideTirzepatide
807. EMEA-001091-PIP02-15 - paediatric investigation plan
808. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
809. ema-daxocoxDaxocox
810. PSUSA/00002152/201602 - periodic safety update report single assessment
811. Betamethasone Dipropionate USP + Clotrimazole USP + Gentamicin Sulfate USP Cream (Phase…
812. EMEA-001284-PIP01-12 - paediatric investigation plan
813. Provisions for Supervision and Administration of Medical Device Distribution
814. Saroglitazar Tablet 4 mg
815. 2026.01.21 G.S.R. 50(E)_Notification for amendment in NDCT Rules, 2019 for online…
816. ema-elelysoElelyso
817. Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
818. Public statement on infliximab (Remicade) on the increased incidence of mortality and…
819. Committee for Orphan Medicinal Products (COMP): 11-13 September 2018
820. ema-tigecycline-accordTigecycline Accord
821. Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC Without…
822. Management Board meeting: 2 October 2025
823. PSUSA/00003155/202305 - periodic safety update report single assessment
824. EU/3/13/1106 - orphan designation for treatment of acute myeloid leukaemia
825. Amendment of the Ministerial Ordinance on Standards for Manufacturing Control and Quality…
826. PSUSA/00010721/202207 - periodic safety update report single assessment
827. 21 CFR 1.650: How must an accredited third-party certification body ensure its audit…
828. Committee for Orphan Medicinal Products (COMP): 10-12 May 2021
829. EMEA-002979-PIP01-21 - paediatric investigation plan
830. EU/3/04/199 - orphan designation for treatment of hyperphenylalaninaemia
831. FDA Releases Agency Overview of Benefits and Concerns Regarding Virtual and Augmented…
832. Vaccines and Related Biological Products Advisory Committee March 12, 2026 Meeting…
833. NitazoxanideTablet 500 mgHydroxychloroquine Tablet 200 mg
834. May 19, 2023: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting…
835. ema-quality-excipientsQuality: excipients
836. Announcement of the National Medical Products Administration on Strengthening Supervision…
837. EU/3/14/1414 - orphan designation for treatment for calciphylaxis
838. PSUSA/00010510/202001 - periodic safety update report single assessment
839. Integrilin - direct healthcare professional communication (DHPC)
840. Medical Devices Violations Guideline
841. Medical device final recall reporting form (FRM-0360)
842. Palivizumab solution for injection 100 mg/ml (r-DNA origin)
843. Workshop on product shortages due to manufacturing and quality problems: Developing a…
844. European Medicines Agency hosts workshop on ethics in paediatric clinical trials
845. ema-xigrisXigris
846. EU big data stakeholder virtual forum
847. EU/3/14/1378 - orphan designation for treatment of hepatocellular carcinoma
848. 21 CFR 868.5895: Continuous ventilator.
849. EU/3/04/201 - orphan designation for prevention of stenosis in synthetic grafts used in…
850. European Medicines Agency recommends authorisation of novel treatment for type-2 diabetes
851. EMEA-001474-PIP01-13-M01 - paediatric investigation plan
852. An Apprenticeship’s ROI? Value, Retention, and So Much More
853. Recommendation-NB-MED-2_1-2_rev5 Explanation of Terms
854. Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment)…
855. EU/3/22/2637 - orphan designation for treatment of partial deep dermal and full thickness…
856. 21 CFR 1.72: Data elements that must be submitted in ACE for articles regulated by FDA.
857. FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to…
858. PSUSA/00009231/201605 - periodic safety update report single assessment
859. PSUSA/00000615/201704 - periodic safety update report single assessment
860. PSUSA/00010217/201909 - periodic safety update report single assessment
861. EU/3/10/803 - orphan designation for treatment of gastric cancer
862. Committee for Advanced Therapies (CAT): 16-18 March 2022
863. PSUSA/00001827/202112 - periodic safety update report single assessment
864. TRIMEDX Joins AAMI BMET Apprenticeship Program as Employer Partner
865. EMA receives application for marketing authorisation for Regkirona (regdanvimab) for…
866. STATE NSQ ALERT FOR THE MONTH OF MAY-2025
867. Frequently Ask Questions (FAQ's) - Medical Device Establishment Licensing and Fees
868. EU/3/22/2605 - orphan designation for treatment of acute lymphoblastic leukaemia
869. Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin + Pioglitazone Hydrochloride eq…
870. Choice of a non-inferiority margin - Scientific guideline
871. Joint Drug Information Association (DIA) / European Forum for Good Clinical Practice…
872. PSUSA/00000101/202306 - periodic safety update report single assessment
873. European Medicines Agency update on non-selective NSAIDs
874. EMEA-001468-PIP01-13 - paediatric investigation plan
875. Meticillin-resistant Staphylococcus aureus in food-producing and companion animals in the…
876. 21 CFR 10.110: Settlement proposals.
877. EMEA-002629-PIP01-19 - paediatric investigation plan
878. Committee for Medicinal Products for Human Use (CHMP): 20-23 March 2017
879. Towards better prevention of medicine shortages in the EU
880. Call for civil society members in Paediatric Committee
881. Paediatric Committee (PDCO): 28-31 January 2020
882. PSUSA/00000072/201608 - periodic safety update report single assessment
883. EU/3/01/077 - orphan designation for treatment of short bowel syndrome
884. EU/3/05/310 - orphan designation for treatment of pulmonary arterial hypertension and…
885. Talzenna - opinion on variation to marketing authorisation
886. 21 CFR 862.1115: Urinary bilirubin and its conjugates (nonquantitative) test system.
887. Committee for Herbal Medicinal Products (HMPC): 20-21 November 2017
888. Regulations for Medicament Contract Manufacture and Analysis
889. Medical Device Premarket Approval and Postmarket Inspections
890. ema-tagrissoTagrisso
891. Guideline on clinical development of fixed combination medicinal products
892. COVID-19 vaccine safety monitoring plan
893. First gene therapy to treat children with rare inherited neurological disease
894. Annex 3b to the Good Manufacturing Practices Guidelines - Positron Emitting…
895. Product Management Service (PMS) Info-Day
896. PSUSA/00002500/201703 - periodic safety update report single assessment
897. EMEA-000920-PIP01-10 - paediatric investigation plan
898. Committee for Advanced Therapies (CAT): 12-14 July 2023
899. EU/3/01/029 - orphan designation for treatment of adenovirus infection in…
900. EMEA-002970-PIP01-21 - paediatric investigation plan
901. cdsco-utiglutide-gl0034Utiglutide (GL0034)
902. European Medicines Agency's workshop on stem cell-based therapies
903. (DOC Version - 131 K)
904. 21 CFR 812.36: Treatment use of an investigational device.
905. Form F201 Change of a Manufacturer's Registration Status
906. EU/3/13/1183 - orphan designation for treatment of congenital sucrase-isomaltase…
907. ema-nuvaxovidNuvaxovid
908. Completing the biowaiver templates
909. Test to verify the analytical sensitivity of COVID-19 Rapid Antigen Test Kits
910. NIMESULIDE GRANULES FOR ORAL SUSPENSION 100MG CT/SND/02/2024
911. EU/3/21/2478 - orphan designation for treatment of frontotemporal dementia
912. ema-scemblixScemblix
913. 23rd meeting of the Committee for Orphan Medicinal Products
914. 21 CFR 898.14: Exemptions and variances.
915. Paediatric Committee (PDCO): 10-12 April 2013
916. FDA recommends thyroid monitoring in babies and young children who receive injections of…
917. EU/3/22/2675 - orphan designation for treatment of primary sclerosing cholangitis
918. Committee for Orphan Medicinal Products (COMP): 19-21 February 2019
919. EMEA-001394-PIP01-12 - paediatric investigation plan
920. EMA explains its redaction rules
921. Handling of the data of clinical studies for medical devices conducted in foreign…
922. EU/3/08/549 - orphan designation for treatment of malignant mesothelioma
923. Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2022
924. ema-hepseraHepsera
925. Guide for Health institutions Who Manufacture and Use In-house IVDs in Ireland
926. EU/3/19/2213 - orphan designation for treatment of growth hormone deficiency
927. Webinar presentation: Management of GMP compliance signals
928. PSUSA/00000964/202012 - periodic safety update report single assessment
929. EU/3/17/1908 - orphan designation for treatment of retinitis pigmentosa
930. PSUSA/00010881/202206 - periodic safety update report single assessment
931. ICH Q4B Annex 14 Bacterial endotoxins tests - Scientific guideline
932. EU/3/18/2096 - orphan designation for treatment of anti-glomerular basement membrane…
933. ema-thalidomide-lipomedThalidomide Lipomed
934. EMEA-002104-PIP01-16 - paediatric investigation plan
935. 21 CFR 820.184: Device history record.
936. Devices made by Silimed: Latest update: 17 October 2016
937. FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or…
938. EU agencies consider phenylbutazone detected in horsemeat of low concern for consumers…
939. EU/3/10/778 - orphan designation for treatment of cystinosis
940. EMEA-001608-PIP02-21 - paediatric investigation plan
941. EMEA-001152-PIP02-16 - paediatric investigation plan
942. 21 CFR 74.3602: D&C Violet No. 2.
943. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - June 2018
944. Cancer Medicines Forum: May 2024
945. 21 CFR 884.3650: Fallopian tube prosthesis.
946. 21 CFR 880.5950: Umbilical occlusion device.
947. Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety…
948. 21 CFR 874.4780: Intranasal splint.
949. Ferric Pyrophosphate citrate
950. Committee for Proprietary Medicinal Products (CPMP) 49th plenary meeting
951. 21 CFR 14.95: Compensation of advisory committee members.
952. cdsco-feb-3-2015-gsr-69-eFeb 3 2015 GSR 69(E)
953. QMS P0014.004 Training Procedure
954. FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for…
955. cdsco-sfilgotinibsFilgotinib
956. ema-tyvasoTyvaso
957. Seasonal Influenza IVD self-tests
958. Therapeutic goods import, advertising and supply compliance education strategy
959. cdsco-insulin-glargineInsulin Glargine
960. 21 CFR 801.55: Request for an exception from or alternative to a unique device identifier…
961. PSUSA/00002333/202108 - periodic safety update report single assessment
962. EMEA-002682-PIP01-19 - paediatric investigation plan
963. Draft of the Drugs and Magic Remedies objectional Advertisments Amendment Bill 2020
964. ema-picatoPicato
965. Regulating Advertising of Health Products
966. The European Commission launches a public consultation on the Paediatric Regulation
967. ema-apixaban-accordApixaban Accord
968. PSUSA-00002656-202202 - periodic safety update report single assessment
969. Fifth Industry Standing Group (ISG) meeting
970. EMEA-000619-PIP02-10 - paediatric investigation plan
971. ema-havrix-referralHavrix - referral
972. Dabigatran etexilate Teva
973. 21 CFR 886.1385: Polymethylmethacrylate (PMMA) diagnostic contact lens.
974. Multidisciplinary: gene therapy
975. Enforcement Rule of the Medical Devices Act
976. EU/3/22/2651 - orphan designation for treatment of Brugada syndrome
977. 21 CFR 868.2450: Lung water monitor.
978. Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 May 2017
979. SOP Guidance for import of vaccine by private sector or any person
980. Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS
981. Report published from workshop on ethics and GCP in clinical trials outside the European…
982. 21 CFR 10.205: Electronic media coverage of public administrative proceedings.
983. 21 CFR 874.3450: Partial ossicular replacement prosthesis.
984. ema-libmeldyLibmeldy
985. Launch of enhanced monitoring system for availability of medicines used for treating…
986. EU/3/19/2224 - orphan designation for treatment of CDKL5 deficiency disorder
987. Aide Memoire on Assessment of Quality Risk Management (QRM) Implementation
988. ‘Brushes in Brazil’ Study Highlights Key Concerns for Endoscope Sterile Processing
989. ema-zinbryta-referralZinbryta - referral
990. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 29…
991. Committee for Advanced Therapies (CAT): 14-16 April 2025
992. 21 CFR 866.3225: Enterovirus nucleic acid assay.
993. EMEA-003198-PIP01-22 - paediatric investigation plan
994. 21 CFR 872.3350: Gold or stainless steel cusp.
995. EU/3/13/1182 - orphan designation for treatment of mastocytosis