Global regulations and guidance

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

1. Clinical trials for medicines: roles and responsibilities
2. Clinical Trials Information System (CTIS) sponsor end user training programme - May 2022
3. ema-fructose-and-sorbitolFructose and sorbitol
4. 21 CFR 1.914: Under what circumstances will we waive a requirement of this subpart?
5. cfr-21-cfr-70-3-definitions21 CFR 70.3: Definitions.
6. Variations for veterinary medicines
7. cdsco-polmacoxib-capsulesPolmacoxib Capsules
8. EU/3/08/530 - orphan designation for treatment of ornithinine transcarbamylase deficiency
9. Non-Prescription Hearing Aids vs Audiologist-Fitted Ones? Study Finds Equal Benefit
10. Reminder to applicants regarding requirements for all future eCTD submissions
11. PSUSA/00010288/202011 - periodic safety update report single assessment
12. ema-zinbrytaZinbryta
13. Hippocastani cortex - herbal medicinal product
14. 21 CFR 864.5350: Microsedimentation centrifuge.
15. European Medicines Agency recommends new contra-indications and warnings for pioglitazone…
16. EMA regular press briefing on COVID-19
17. Pharmacogenomics Working Party
18. EU/3/04/249 - orphan designation for treatment of follicular lymphoma
19. PSUSA/00000330/201706 - periodic safety update report single assessment
20. Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and…
21. EMEA-002335-PIP01-18 - paediatric investigation plan
22. FDA Delays UDI Enforcement in Midst of COVID-19
23. PSUSA/00010488/201705 - periodic safety update report single assessment
24. PSUSA/00001469/202005 - periodic safety update report single assessment
25. Important regulatory considerations for the supply of medical gowns - Guidance to Industry
26. 21 CFR 814.100: Purpose and scope.
27. Guidance on Evaluation of Orthopedic Customized Artificial Hip Joint Prosthesis [88.08 KB]
28. EMEA-000398-PIP01-08 - paediatric investigation plan
29. ema-aranespAranesp
30. 21 CFR 882.1620: Intracranial pressure monitoring device.
31. nbcg-team-nb-member-list-45Team-NB Member List 45
32. ema-genotropin-referralGenotropin - referral
33. EU/3/21/2460 - orphan designation for treatment of primary biliary cholangitis
34. 21 CFR 878.3610: Esophageal prosthesis.
35. Committee for medicinal products for veterinary use: Meeting of 12 to 14 April 2005
36. EMEA-001842-PIP02-15 - paediatric investigation plan
37. EU/3/13/1113 - orphan designation for prevention of graft rejection following solid organ…
38. FDA Advancing Regulatory Science for Chemical Characterization
39. cdsco-tildrakizumab23janTildrakizumab23jan
40. Cobactan IV 4.5% powder and solvent for solution for injection and its associated names…
41. EU/3/05/280 - orphan designation for treatment of B-cell chronic lymphocytic leukaemia
42. FDA Grants Breakthrough Device Designation to Neuralert’s Stroke Detection System
43. 21 CFR 878.3900: Inflatable extremity splint.
44. cdsco-vib7734VIB7734
45. Need for active control in therapeutic areas where use of placebo is deemed ethical and…
46. 21 CFR 13.5: Notice of a hearing before a Board.
47. Committee for Proprietary Medicinal Products (CPMP) 35th plenary meeting
48. ema-capecitabine-accordCapecitabine Accord
49. Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 November 2013
50. ema-ecoporc-shigaEcoporc Shiga
51. Committee for Medicinal Products for Human Use (CHMP): 12-15 October 2026
52. PSUSA/00000973/201601 - periodic safety update report single assessment
53. Eighth meeting of the EMEA Human Scientific Committees' Working Party with with Patients'…
54. ema-brukinsaBrukinsa
55. ICEHTMC Headed for India: ‘An Opportunity That Should Not Be Missed’
56. Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
57. End of year message from EMA's Executive Director
58. Drug Safety Update: monthly PDF newsletter: Drug Safety Update May 2021
59. EMEA-000118-PIP02-10-M03 - paediatric investigation plan
60. 21 CFR 20.51: Referral to primary source of records.
61. cdsco-tirzepatideTirzepatide
62. PSUSA/00001243/202204 - periodic safety update report single assessment
63. ema-kriptazenKriptazen
64. (Attachment) Questions and Answers (Q & A) on Guidelines for Clinical Studies of Vaccines…
65. 21 CFR 870.1250: Percutaneous catheter.
66. Committee for Veterinary Medicinal Products: 49th meeting
67. 21 CFR 4.100: What is the scope of this subpart?
68. A practical approach to effective lifecycle implementation of systems and processes for…
69. European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic…
70. ema-joint-audit-programmeJoint Audit Programme
71. Guide to Drug-Device Consultations
72. Novel Corona virus-2019-nCoV Vaccine
73. FDA Warns Compounds Used for Dialysis, Incubators May Present Risks
74. 21 CFR 864.5220: Automated differential cell counter.
75. cdsco-delamanidDelamanid
76. PSUSA/00000420/201511 - periodic safety update report single assessment
77. dInsulinGlargineInjection 100IU/ml
78. EMEA-002031-PIP01-16-M03 - paediatric investigation plan
79. NMPA and NHC Issued Regulations for Administration of Medical Device Extended Clinical…
80. Sixth stakeholder forum on the implementation of the new pharmacovigilance legislation
81. EMEA-001371-PIP01-12 - paediatric investigation plan
82. Sterilization Central: A Look at PPE-Related Challenges and Perceptions from the…
83. EMEA-000832-PIP01-10-M05 - paediatric investigation plan
84. EMEA-000026-PIP02-11 - paediatric investigation plan
85. COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine
86. EU/3/08/594 - orphan designation for treatment of hypophosphatasia
87. Uvae ursi folium - herbal medicinal product
88. Questions and Answers (Q&A) about Handling of Application for Confirmation of Change…
89. ema-tyenneTyenne
90. EU/3/19/2166 - orphan designation for treatment of carbamoyl-phosphate synthase-1…
91. EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) elects new Chair
92. PSUSA/00002254/202304 - periodic safety update report single assessment
93. Assurances to accompany an OTC new medicine N2 application
94. EU/3/14/1359 - orphan designation for treatment of mucopolysaccharidosis type I
95. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16…
96. EU/3/20/2311 - orphan designation for treatment of mitochondrial encephalomyopathy, lactic…
97. European Medicines Agency recommends precautionary recall of remaining batch of Vistide…
98. VICH GL1 Validation of analytical procedures: definition and terminology - Scientific…
99. Trastuzumab Deruxtecanas
100. Glossary of Computer Systems Software Development Terminology (8/95)
101. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May…
102. EMEA-001807-PIP02-15 - paediatric investigation plan
103. Stainless Steel
104. PSUSA/00010957/202204 - periodic safety update report single assessment
105. Committee for Advanced Therapies (CAT): 10-11 December 2015
106. cdsco-isophane-insulinIsophane Insulin
107. ema-rofecoxib-referralRofecoxib - referral
108. Submitting data in the eCTD format
109. European Medicines Agency closed 23 December 2011 to 2 January 2012
110. ema-pluvictoPluvicto
111. 21 CFR 874.1800: Air or water caloric stimulator.
112. Quality of medicines Q&A - Introduction
113. European Surveillance of Veterinary Antimicrobial Consumption stakeholders meeting 2015
114. ema-biostatisticsBiostatistics
115. PSUSA/00010508/201709 - periodic safety update report single assessment
116. 21 CFR 888.3120: Ankle joint metal/polymer non-constrained cemented prosthesis.
117. Management Board meeting: 16 June 2016
118. How tests and testing kits for coronavirus (COVID-19) work: Guidance for manufacturers…
119. Committee for Herbal Medicinal Products (HMPC): 17-19 July 2023
120. 21 CFR 82.1104: D&C Blue No. 4.
121. EMEA-001962-PIP01-16 - paediatric investigation plan
122. PSUSA/00002429/202204 - periodic safety update report single assessment
123. DCGI New Year Massage for 2020
124. FDA adds warning about serious risk of heat-related complications with antinausea patch…
125. European SME Week: 3-9 October 2011
126. Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19
127. Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on…
128. European Medicines Agency recommends restricting use of cilostazol-containing medicines
129. AAMI and BSI Join Forces to Publish Guidance on Artificial Intelligence
130. 21 CFR 888.3510: Knee joint femorotibial metal/polymer constrained cemented prosthesis.
131. Committee for Medicinal Products for Human Use (CHMP): 22-25 July 2019
132. PSUSA/00000685/201508 - periodic safety update report single assessment
133. EMEA-000060-PIP04-14-M01 - paediatric investigation plan
134. 21 CFR 862.1720: Triose phosphate isomerase test system.
135. European Medicines Agency confirms positive benefit-risk balance of pholcodine-containing…
136. Valproate - Children born to mothers who took Valproate products while pregnant may have…
137. Prasugrel Viatris (previously Prasugrel Mylan)
138. Classifications as minor-use-minor-species and limited-market according to former EMA…
139. OPEN framework extended to a wider range of medicines
140. Lanreotide acetate product-specific bioequivalence guidance
141. PSUSA/00010696/202101 - periodic safety update report single assessment
142. Paediatric Committee (PDCO): 10-13 December 2024
143. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March…
144. EMA Management Board: highlights of June 2017 meeting
145. EU/3/21/2457 - orphan designation for treatment of methylmalonic acidaemia
146. Global regulatory workshop on COVID-19 real-world evidence and observational studies
147. 21 CFR 82.705: FD&C Yellow No. 5.
148. Triamcinolone acetonide IP Lignocaine HCl IP Gel
149. cdsco-noticeNotice
150. Testing and evaluation of the efficacy of antiparasitic substances for the treatment and…
151. Gene therapy product quality aspects in the production of vectors and genetically modified…
152. ema-elmironElmiron
153. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 September 2014
154. Anika Therapeutics S.r.l. withdraws its marketing-authorisation application for Hyalograft…
155. 21 CFR 892.2080: Radiological computer aided triage and notification software.
156. cdsco-pirfenidone-267-mg-tabPirfenidone 267 mg tab
157. European Union (EU) International Organisation for Standardization (ISO) for…
158. Stability testing for applications for variations to a marketing authorisation for…
159. EU/3/16/1675 - orphan designation for treatment of acute liver failure
160. Virus safety evaluation of biotechnological investigational medicinal products…
161. PSUSA/00001662/201801 - periodic safety update report single assessment
162. EMA business hours over holiday period
163. cdsco-art-123ART-123
164. cdsco-baloxavir-marboxilbaloxavir marboxil
165. EU/3/06/367 - orphan designation for treatment of solitary bone cysts
166. European Medicines Agency to review COX-2 inhibitors
167. 2018.12.07_Draft_GSR 1187(E)_Amendment of Rule 91 and the Second Schedule for fees of free…
168. 2012.03.29_S.O. 652(E)_Dr. M.F.A. Beg, SSO, CDL, Kolkata_Signing Authority_COA
169. Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories…
170. ema-lodipressinLodipressin
171. 21 CFR 26.5: Length of transition period.
172. November 16, 2017: Meeting of the Antimicrobial Drugs Advisory Committee Meeting…
173. EMEA-002132-PIP01-17 - paediatric investigation plan
174. NMPA Announcement on Issuing the Standard for the Evaluation of Efficacy Claims of…
175. EU/3/14/1294 - orphan designation for treatment of necrotising soft tissue infections
176. cdsco-20122012
177. Quality of combination herbal medicinal products/traditional herbal medicinal products…
178. Clinical Trials Information System (CTIS) sponsor end user training programme - January…
179. 21 CFR 872.4120: Bone cutting instrument and accessories.
180. 21 CFR 876.4530: Gastroenterology-urology fiberoptic retractor.
181. PSUSA/00002774/201908 - periodic safety update report single assessment
182. CAT: meeting archive 2013-2016
183. 21 CFR 864.7375: Glutathione reductase assay.
184. 21 CFR 872.3480: Polyacrylamide polymer (modified cationic) denture adhesive.
185. cdsco-lyt-100LYT-100
186. EMEA-001869-PIP01-15-M02 - paediatric investigation plan
187. Western Pharmaceuticals Good Distribution Practice Regulations
188. Committee for Herbal Medicinal Products (HMPC): 24-25 September 2018
189. Guide for Suppliers of First Aid Kits Containing Medicinal Products Supplying Solely to…
190. EU/3/16/1668 - orphan designation for treatment of cystic fibrosis
191. Ch. 11 - Glossary
192. 21 CFR 895.30: Special effective date.
193. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11…
194. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 August 2013
195. Q&A clinic on Product Management Service (PMS) Product User Interface - 23 July 2024
196. AAMI Names 2021 Award Winners
197. EU/3/15/1594 - orphan designation for treatment of malignant mesothelioma
198. 21 CFR 820.72: Inspection, measuring, and test equipment.
199. Committee for Proprietary Medicinal Products (CPMP): meeting of 18 to 20 June 2001
200. Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting…
201. Standards for Medicament Factory Establishments
202. Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys…
203. ema-teslascanTeslascan
204. EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
205. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 February 2010
206. VICH GL8 Stability testing for medicated premixes - Scientific guideline
207. EU/3/08/578 - orphan designation for treatment of cystinosis
208. EMEA-002750-PIP01-19 - paediatric investigation plan
209. EMEA-002298-PIP01-17-M05 - paediatric investigation plan
210. PSUSA/00003002/201705 - periodic safety update report single assessment
211. ICH Q4B Annex 7 Dissolution test - Scientific guideline
212. Notice to Stakeholders - Invitation to Participate in a Survey for Canadian Active…
213. EU/3/15/1480 - orphan designation for treatment of Ebola virus disease
214. Committee for Orphan Medicinal Products (COMP)
215. 2018.11.29_Draft G.S.R. 1153(E)_Reg. Cosmetics Rules, 2018
216. New medicine to treat perianal fistulas in patients with Crohn's disease
217. FGK Representative Service GmbH withdraws its marketing-authorisation application for…
218. 21 CFR 874.1925: Toynbee diagnostic tube.
219. Revised guideline on biosimilars containing biotechnology-derived proteins published for…
220. PSUSA/00002104/201803 - periodic safety update report single assessment
221. cdsco-ligelizumab-qge031ligelizumab (QGE031)
222. Teneligliptin IP + Rosuvastatin Calcium IP tablets (Phase III)
223. Pharmaceutical Affairs Act Enforcement Rules
224. PSUSA/00009182/202312 - periodic safety update report single assessment
225. European Medicines Agency recommends limiting long-term use of calcitonin medicines
226. Extension of Date of Notice Inviting Tender (NIT) Last Date( 27 Jul 2012 )
227. EU/3/22/2727 - orphan designation for diagnosis of neuroendocrine neoplasms
228. EU/3/16/1700 - orphan designation for treatment of hepatocellular carcinoma
229. EU/3/05/333 - orphan designation for treatment of diffuse alveolar haemorrhage
230. ema-helicobacter-test-infaiHelicobacter Test INFAI
231. Questions and answers on gene therapy - Scientific guideline
232. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
233. PSUSA/00010245/201603 - periodic safety update report single assessment
234. Pembrolizumab concentrate for solution for Infusion in Vial 25mg/mL (100mg/4 mL) (rDNA…
235. Potassium Chloride (K-Lyte)
236. 21 CFR 868.5750: Inflatable tracheal tube cuff.
237. EU/3/23/2750 - orphan designation for treatment of lomentosporiosis
238. PSUSA/00001057/202303 - periodic safety update report single assessment
239. NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF MARCH-2025
240. European Medicines Agency welcomes new Head of Infrastructure Services
241. Procedural advice for veterinary vaccine antigen master file (VAMF) certification…
242. 21 CFR 868.5330: Breathing gas mixer.
243. EU/3/21/2532 - orphan designation for treatment of hereditary angioedema
244. Regulatory information - EMA encourages companies to submit quality type-I variations for…
245. Wong and Razzano: Financial Objections Don't Add Up in Monitoring Debate
246. Guide to Vigilance System for Medical Devices
247. Esaxerenone Tablets 1.25 mg or 2.5 mg or 5 mg
248. Fibrinogen-containing solutions for sealant authorised for administration by spray…
249. PSUSA/00010648/202106 - periodic safety update report single assessment
250. Clinical trials' transition to new EU system - one year left
251. 21 CFR 882.4250: Cryogenic surgical device.
252. EU/3/16/1809 - orphan designation for treatment of Cockayne syndrome
253. Human variations electronic application forms Q&A clinics – session 5
254. EMEA-001344-PIP02-17 - paediatric investigation plan
255. Notice Pathway for subsequent manufacture of category d FDCs as per Prof. Kokate Committee…
256. European Medicines Agency:Committee for Medicinal Products for Human Use24-27 April 2006
257. 21 CFR 74.3710: D&C Yellow No. 10.
258. First-in-class medicine to prevent bleeding in haemophilia A patients with inhibitors
259. First clinical biomarker qualification released for public consultation
260. EMEA-002341-PIP01-18-M02 - paediatric investigation plan
261. cdsco-may-30-2011-gsr-418-eMay 30, 2011 (GSR 418 (E)
262. 21 CFR 830.350: Correction of information submitted to the Global Unique Device…
263. EMEA-001475-PIP01-13 - paediatric investigation plan
264. European Medicines Agency closed 29 August 2011
265. Combined hormonal contraceptives - referral
266. Notice regarding Pending status
267. Form for providing product information
268. Shaping the future of human and animal health in the EU
269. European regulators make recommendations drawing on lessons learnt from presence of…
270. EMA and Association of the European Self-Medication Industry (AESGP) annual bilateral…
271. EMEA-000311-PIP01-08-M04 - paediatric investigation plan
272. Collaborative COVID-19 Response Brings Out the Best in HTM
273. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 January 2011
274. EU/3/02/118 - orphan designation for prevention of post-transplantation…
275. Application for a new registered complementary medicine - grouped medicine
276. 21 CFR 888.3750: Wrist joint carpal lunate polymer prosthesis.
277. 8th meeting of the committee for veterinary medicinal products
278. PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing…
279. BMET Apprenticeship Program Secures First Official Partner
280. EMEA-001943-PIP03-20-M01 - paediatric investigation plan
281. EMEA-002381-PIP01-18 - paediatric investigation plan
282. EMEA-000365-PIP01-08-M12 - paediatric investigation plan
283. EU/3/01/066 - orphan designation for treatment of erythema nodosum leprosum (ENL) or type…
284. 21 CFR 874.3495: Total ossicular replacement prosthesis.
285. 21 CFR 1.384: When does a detention order terminate?
286. The Consultant Is In: A Panel at AAMI eXchange
287. ema-elebrato-elliptaElebrato Ellipta
288. Q&A on the Master File (MF) System, Part IV
289. PSUSA/00000236/202210 - periodic safety update report single assessment
290. June 26, 2024: Tobacco Products Scientific Advisory Committee Meeting - 06/26/2024
291. Development challenges for medicines for central nervous system disorders
292. PSUSA/00002943/202106 - periodic safety update report single assessment
293. 21 CFR 20.64: Records or information compiled for law enforcement purposes.
294. Committee for Advanced Therapies (CAT): 19-21 June 2024
295. 21 CFR 886.1930: Tonometer and accessories.
296. Varicella Zoster Virus (VZV) Vaccine
297. cdsco-ct-05-2024-tbCT-05 2024 TB
298. PSUSA/00001834/201710 - periodic safety update report single assessment
299. Better surveillance needed to fight spread of antimicrobial resistance in zoonotic…
300. NSQ ALERT FOR THE MONTH OF JUNE 2024
301. Committee for Orphan Medicinal Products (COMP): 3-5 November 2021
302. Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
303. Paediatric Committee (PDCO): 24-27 February 2026
304. EU/3/23/2783 - orphan designation for treatment of Charcot-Marie-Tooth disease
305. Chapter 2 - Product Type Guidance Northern Ireland
306. EU/3/19/2215 - orphan designation for treatment of soft tissue sarcoma
307. AD HOC working group on herbal medicinal products meeting of the 24-25 November 1997
308. 21 CFR 73.1010: Alumina (dried aluminum hydroxide).
309. Checklist for Form MD-28 IVD (Application for grant of permission to import or Manufacture…
310. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
311. ema-renvelaRenvela
312. cdsco-rivacaRIVACA
313. Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU…
314. EMEA-000459-PIP01-08-M02 - paediatric investigation plan
315. Lasofoxifene tartrate - paediatric investigation plan
316. European Medicines Agency Human Scientific Committees' Working Parties with Patients' and…
317. EU/3/10/772 - orphan designation for treatment of mucopolysaccharidosis, type IIIA…
318. First-in-class medicine to treat aggressive form of breast cancer
319. EU/3/23/2846 - orphan designation for treatment of narcolepsy
320. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (London)
321. Guideline on clinical trials with haematopoietic growth factors for the prophylaxis of…
322. Cellular Biology Based Therapeutic Drug Evaluation Committee (CBTDEC)
323. EMEA-002745-PIP02-20 - paediatric investigation plan
324. 21 CFR 10.105: Representation by an organization.
325. Briviact (in Italy: Nubriveo) - direct healthcare professional communication (DHPC)
326. Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
327. Clinical Trials Information System (CTIS) sponsor end user training programme - September…
328. cdsco-meeting-noticeMeeting Notice
329. ema-aloxiAloxi
330. 21 CFR 822.29: May I request a waiver of a specific requirement of this part?
331. Alkermes Pharma Ireland Limited withdraws its marketing authorisation application for…
332. PSUSA/00000535/202004 - periodic safety update report single assessment
333. 21 CFR 884.5200: Hemorrhoid prevention pressure wedge.
334. 21 CFR 74.1327: D&C Red No. 27.
335. 21 CFR 822.21: What must I do if I want to make changes to my postmarket surveillance plan…
336. Expressions of interest invited for membership of European Medicines Agency committees and…
337. NMPA Announcement on Issuing the Catalogue of Distribution of Class II Medical Devices…
338. Samples declared NSQ 2017
339. ema-cabazitaxel-accordCabazitaxel Accord
340. ema-olazax-disperziOlazax Disperzi
341. NLEA, Nutrient Sample Analysis, and General Food Labeling Requirements Program - Import…
342. EU/3/03/149 - orphan designation for treatment of pancreatic cancer in combination with…
343. NMPA Issued Four Guidelines for Technical Review of the Registration of Assay Reagents for…
344. EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
345. European Agency for the evaluation of medicinal products: Committee for Proprietary…
346. EMEA-002173-PIP01-17 - paediatric investigation plan
347. PSUSA/00000112/201705 - periodic safety update report single assessment
348. 2nd DIA/EMA Innovation Forum: Is the EU regulatory framework ready?
349. FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope…
350. 21 CFR 880.6100: Ethylene oxide gas aerator cabinet.
351. Advertise your medicines
352. ema-taltzTaltz
353. Lena Cordie-Bancroft: What Should We Expect in 2022?
354. Reproduce or re-use MHRA information: Application form for a data extract from our data…
355. Consumption of antimicrobials in animals reaches lowest level ever in Europe
356. EU/3/21/2432 - orphan designation for treatment of fragile X syndrome
357. PSUSA/00003017/201707 - periodic safety update report single assessment
358. cdsco-general-orderGENERAL ORDER
359. Inviting public comments, as steps are being taken taken by CDSCO to regulate the products…
360. 21 CFR 82.2051: Lakes (Ext. D&C).
361. Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
362. (DOC Version - 30 KB)
363. Veterinary Medicines - Availability (minor uses/minor species)
364. Thalidomide BMS (previously Thalidomide Celgene)
365. Drug Alert list for month of May 2019
366. Committee for Herbal Medicinal Products (HMPC): 23-24 January 2012
367. EMEA-003181-PIP01-22 - paediatric investigation plan
368. Meeting of the EMEA working party on herbal medicinal products 24 - 25 February 2003
369. Quinolone- and fluoroquinolone-containing medicinal products - referral
370. Update on publication of clinical data
371. cdsco-aviptadilAviptadil
372. Novartis withdraws its marketing authorisation application for Joicela (lumiracoxib)
373. EMEA-000309-PIP04-17-M03 - paediatric investigation plan
374. PSUSA/00010492/202304 - periodic safety update report single assessment
375. ema-repsoRepso
376. cdsco-pertuzumabfPertuzumabf
377. Regulatory information - Committee chairs' handwritten signatures no longer included in…
378. 21 CFR 866.3065: Bordetella spp. serological reagents.
379. DTAB Sub-Committee to examine the proposal to regulate antibiotic and its irrational use…
380. European Medicines Agency and payer community meeting
381. ema-yseltyYselty
382. EU/3/03/183 - orphan designation for treatment of Burkholderia cepacia lung infection in…
383. Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External…
384. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22…
385. The annual European Medicines Agency review of the year and outlook for 2014
386. Antiarrhythmics - Scientific guideline
387. EU/3/02/107 - orphan designation for treatment of partial deep dermal and full-thickness…
388. Crestor and associated names - referral
389. Amendments to the pharmacovigilance legislation: new notification requirements for…
390. For AAMI Association of the Year Winner CABMET, Communication Is Key
391. EU/3/08/599 - orphan designation for treatment of Duchenne muscular dystrophy
392. QMS P0015.004 Naming Convention of Electronic Record Policy
393. PSUSA/00002068/201808 - periodic safety update report single assessment
394. 21 CFR 880.2700: Stand-on patient scale.
395. cdsco-lnp3794-in-apatientsLNP3794 in apatients
396. World Cancer Day: 4 February 2013
397. 21 CFR 876.5340: Nonimplanted nerve stimulator for functional abdominal pain relief.
398. Changing the name or address of a sponsor
399. Details of Manufacturers whose permissions have been suspended / cancelled 2022
400. 21 CFR 810.17: Termination of a cease distribution and notification or mandatory recall…
401. Atezolizumab(ANTI-PD-L1Antibody)
402. DR_G.S.R. 245(E) dt_05.04.1999_Amendment to Rule 122_Requirements of blood bank
403. First stem cell-based veterinary medicine recommended for marketing authorisation
404. Ximelagatran 36 mg film coated tablets
405. 21 CFR 862.1725: Trypsin test system.
406. Leucofeligen FeLV/RCP - opinion on variation to marketing authorisation
407. ema-inductos-referralInductos - referral
408. Refusal of orphan designation for treatment of partial deep dermal and full-thickness…
409. sImeglimin Hydrochloride 1000 tablets
410. ema-humenzaHumenza
411. EMEA-001007-PIP01-10 - paediatric investigation plan
412. EMEA-002440-PIP01-18-M04 - paediatric investigation plan
413. PSUSA/00010269/202107 - periodic safety update report single assessment
414. 21 CFR 820.181: Device master record.
415. EU/3/19/2244 - orphan designation for treatment of systemic sclerosis
416. Notice regarding Launching of Online portal SUGAm for import and registration of Medical…
417. Workshop on medicines for bees: What the European Medicines Agency can do to increase…
418. EU/3/15/1446 - orphan designation for treatment of progressive supranuclear palsy
419. 21 CFR 73.1327: Chromium oxide greens.
420. Medicinal Products (Prescription and Control of Supply) (Amendment) (No 5) Regulations…
421. cdsco-dalbavancinDalbavancin
422. ema-buying-medicines-onlineBuying medicines online
423. Guido Rasi begins as new head of European Medicines Agency
424. Bevacizumab Solution for Injection 25 mg/mL (Vial 5.75 mg/0.23 mL) (rDNA origin)
425. 21 CFR 864.2260: Chromosome culture kit.
426. Regulatory information – adjusted fees for pharmacovigilance applications from 18 October…
427. AI Airlock Simulation Workshops
428. NMPA Notice on Issuing the Guidance for Technical Review of Clinical Evaluation of…
429. List of Clarifications/NOCs Issue from 2011- 2018
430. PSUSA/00010178/201808 - periodic safety update report single assessment
431. 21 CFR 56.110: Expedited review procedures for certain kinds of research involving no more…
432. Drug Regulatory and Law Enforcement Agencies Intensify Coordinated Action Against Illegal…
433. cdsco-brazikumabBrazikumab
434. EMEA-001006-PIP01-10 - paediatric investigation plan
435. European Medicines Agency recommends action plan to deal with possible presence of…
436. EU/3/11/930 - orphan designation for treatment of Hodgkin's lymphoma
437. ema-sildenafil-actavisSildenafil Actavis
438. Committee for Orphan Medicinal Products (COMP): 16-18 April 2024
439. Committee for veterinary medicinal products: Meeting of 16 to 17 September 2003
440. PSUSA/00003151/202308 - periodic safety update report single assessment
441. Committee for Advanced Therapies (CAT): 18-19 June 2015
442. EMA starts review of VIR-7831 for treating patients with COVID-19
443. Silodosin + Mirabegron (SR) film coated bilayered tablets (Phase III)
444. ema-simparicaSimparica
445. Assistive technology: definitions, examples and safe use: Assistive technology: definition…
446. EU/3/23/2862 - orphan designation for treatment of perinatal asphyxia
447. Adcirca (previously Tadalafil Lilly)
448. EMEA-001877-PIP03-17 - paediatric investigation plan
449. EU/3/18/1984 - orphan designation for treatment of primary IgA nephropathy
450. 21 CFR 803.58: Foreign manufacturers.
451. Regulation 251 of the Human Medicines Regulations 2020
452. Cobactan DC and its associated names - referral
453. EMEA-001396-PIP01-12 - paediatric investigation plan
454. Request to reinstate an entry on the Australian Register of Therapeutic Goods (ARTG)
455. World Hypertension Day: 17 May 2012
456. Twenty-fourth Meeting of the Management Board
457. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21…
458. Questions & Answers about Handling of Medical Device Software
459. cdsco-daprodustatDaprodustat
460. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
461. Inspections of CDER-led or CDRH-led Combination Products
462. Application for withdrawal from G.P.F Form(Related to Employees)
463. cdsco-capivasertib-docetaxelCapivasertib + Docetaxel
464. 21 CFR 821.30: Tracking obligations of persons other than device manufacturers…
465. 21 CFR 821.20: Devices subject to tracking.
466. ema-neupopegNeupopeg
467. Joint European Medicines Agency (EMA), US Food and Drug Administration (FDA), and Japanese…
468. ema-canazole-referralCanazole - referral
469. Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2016
470. EU/3/17/1953 - orphan designation for treatment of Fabry disease
471. EU/3/12/956 - orphan designation for treatment of pemphigus
472. EU/3/15/1550 - orphan designation for treatment of idiopathic pulmonary fibrosis
473. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - May 2023
474. Disposable Laser Optical Fiber Kit Approved for Marketing
475. PSUSA/00010001/201509 - periodic safety update report single assessment
476. EU/3/17/1841 - orphan designation for treatment of von Hippel-Lindau disease
477. PSUSA/00010489/201805 - periodic safety update report single assessment
478. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 3) Regulations…
479. 21 CFR 862.1810: Vitamin B12 test system.
480. PSUSA/00001026/201612 - periodic safety update report single assessment
481. EMEA-002030-PIP01-16 - paediatric investigation plan
482. 2018 European Union Good Clinical Practice Inspectors Working Group workshop
483. EMEA-000654-PIP01-09-M02 - paediatric investigation plan
484. ema-non-clinical-toxicologyNon-clinical: toxicology
485. William Hyman: Precision Matters in Medical Device Terminology
486. ema-grasustekGrasustek
487. Questions and Answers (Q&A) on the “Guidelines for Clinical Evaluation of Drugs for the…
488. ICH Q5E Biotechnological/biological products subject to changes in their manufacturing…
489. 21 CFR 868.1700: Nitrous oxide gas analyzer.
490. cagrilintide and semaglutide (CagriSema) 2.4mg/2.4mg s.c.
491. 21 CFR 99.403: Termination of approvals of applications for exemption.
492. NSQ May 2024 State Labs
493. Register a homeopathic medicine
494. European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of…
495. Combisyn Lactating Cow - referral
496. ema-syfovreSyfovre
497. EMEA-000093-PIP02-10 - paediatric investigation plan
498. Efficacy and target animal safety data requirements for applications for non-immunological…
499. Webinar presentation: TGO 110: Standard for unapproved vaporiser nicotine products, 4…
500. cdsco-noxaparin-in-covid-19noxaparin) in COVID-19
501. Dinutuximab and Irinotecan
502. Pregabalin IP (as prolonged release) + Etoricoxib IP uncoated bilayered tablets (Phase IV)
503. Committee for Advanced Therapies (CAT): 18-20 March 2026
504. 21 CFR 821.55: Confidentiality.
505. cdsco-benralizumabBenralizumab
506. ema-pemetrexed-accordPemetrexed Accord
507. European Medicines Agency agrees on action plan following the recall of Viracept and…
508. Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 May 2016
509. Centellae asiaticae herba - herbal medicinal product
510. cdsco-dolutegravir-phase-ivDolutegravir (Phase IV)
511. cdsco-desidustat-50-mgDesidustat 50 mg
512. NYC’s Northwell Health Introduces Pregnancy Chatbot to Reduce Maternal Mortality
513. Announcement of National Medical Products Administration and National Intellectual…
514. ema-ivabradine-jensonrIvabradine JensonR
515. 21 CFR 56.112: Review by institution.
516. Dapagliflozin + Vildagliptin tablets (Phase III)
517. ema-samscaSamsca
518. 21 CFR 874.3375: Battery-powered artificial larynx.
519. cdsco-molnupiravir-milds1Molnupiravir Milds1
520. Guidance on applications for COVID-19 medical device clinical trials under the Regulations
521. PSUSA/00001349/202012 - periodic safety update report single assessment
522. EMEA-003133-PIP01-21 - paediatric investigation plan
523. EMEA-002202-PIP01-17 - paediatric investigation plan
524. Classification of Newly Notified Medical Devices to be updated with Classification list of…
525. 21 CFR 870.1425: Programmable diagnostic computer.
526. 21 CFR 1.1325: What records must I keep and provide when I harvest or cool a raw…
527. European Medicines Agency recommends authorisation of two additional Bluetongue vaccines…
528. cdsco-pimavenserin-capsulesPimavenserin Capsules
529. 21 CFR 26.40: Start of the operational period.
530. 21 CFR 884.2900: Fetal stethoscope.
531. AAMI Foundation Awards ECRI Grant to Conduct Gown Contamination Research
532. Committee for Advanced Therapies (CAT): 8-9 September 2016
533. Two new medicines recommended for the treatment of chronic hepatitis C
534. BEMNIFOSBUVIR (BEM) AND RUZASVIR (RZR)
535. EMEA-000965-PIP01-10 - paediatric investigation plan
536. Alcaftadine Nasal Spray
537. Guideline for Exposure-Response Analysis of Drugs
538. PSUSA/00009317/201603 - periodic safety update report single assessment
539. First two CAR-T cell medicines recommended for approval in the European Union
540. Barrett Franklin: A Strong Start to AAMI 2012
541. cdsco-buprenorphineBuprenorphine
542. Committee for Medicinal Products for Human Use (CHMP): 10-13 December 2018
543. COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low…
544. EMEA-002504-PIP01-18 - paediatric investigation plan
545. Regulations for Management of Medical Device Safety Surveillance
546. Medicines: terminated and cancelled manufacturing and wholesale dealer licences
547. P/12/2009 - paediatric investigation plan
548. EU/3/18/2094 - orphan designation for treatment of neuroblastoma
549. BMET Apprenticeship Program Flourishes in Successful First Year
550. PSUSA-00002110-202305 - periodic safety update report single assessment
551. ema-boric-acid-and-boratesBoric acid and borates
552. PSUSA/00000017/201503 - periodic safety update report single assessment
553. 22.06.14_Draft_GSR 448(E)_Amendment in rule 96 for mandating Bar code or QR code on the…
554. Disposable Radiofrequency Atrial Septal Puncture Needle Approved for Marketing
555. Paxlovid - direct healthcare professional communication (DHPC)
556. ema-feraccruFeraccru
557. 21 CFR 1.95: Application for authorization to relabel and recondition.
558. ema-aA
559. FDA evaluating the risks of using the pain medicine tramadol in children aged 17 and…
560. Dapagliflozin + Metformin Hydrochloride IP (Extended Release) + Sitagliptin Phosphate…
561. cfr-21-cfr-26-3-scope21 CFR 26.3: Scope.
562. Efonidipine Hydrochloride Ethanolate IP + Telmisartan IP film coated tablets (Phase III)
563. Call for Healthcare Technology’s ‘Bright Ideas’ 2024
564. ema-valdoxanValdoxan
565. Increased manufacturing capacity and supply for Spikevax
566. VICH GL39 Test procedures and acceptance criteria for new veterinary drug substances and…
567. EU/3/13/1226 - orphan designation for treatment of dystrophic myotonia
568. Paediatric Committee (PDCO): 26-29 May 2020
569. PSUSA/00002709/202004 - periodic safety update report single assessment
570. EMEA-000558-PIP02-10 - paediatric investigation plan
571. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31…
572. Dutch authorities hand over final building to EMA in Amsterdam
573. 21 CFR 862.3200: Clinical toxicology calibrator.
574. The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety…
575. 21 CFR 814.102: Designation of HUD status.
576. Cystagon - direct healthcare professional communication (DHPC)
577. Discover the Ins and Outs of an HTM Leadership Role
578. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 April 2024
579. GN-17 R2 Guidance on Preparation of a Product Registration Submission for GMD using the…
580. Procedure to be followed for subsequent application in respect of FDCs declared as…
581. Evenamide(NW-3509/006/III/2019)
582. EMEA-002776-PIP01-20-M01 - paediatric investigation plan
583. Committee for Advanced Therapies (CAT): 22-23 March 2023
584. Quadrivalent Human Papillomavirus (Type 6, 11, 16, 18) Vaccine (Recombinant)
585. ema-exuberaExubera
586. PSUSA/00000584/201707 - periodic safety update report single assessment
587. European Medicines Agency appoints Head of International and European Cooperation
588. European Union International Organisation for Standardization (ISO) identification of…
589. E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions R4 (2025 OCT)…
590. PRAC confirms four-week limit for use of high-strength estradiol creams
591. Lifeviro treat inhalation
592. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 October…
593. Revised transparency rules for the EU Clinical Trials Information System (CTIS)
594. European Medicines Agency publishes video explaining pharmacovigilance legislation
595. EU/3/12/1006 - orphan designation for treatment of glioma
596. Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA…
597. EU/3/12/1098 - orphan designation for treatment of retinitis pigmentosa
598. EMEA-000078-PIP01-07-M08 - paediatric investigation plan
599. ema-esmya-referralEsmya - referral
600. FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain…
601. Fluticasone furoate and vilanterol inhalation powder 100mcg/25mcg
602. Come to the Light: Common Problems a BMET Might Encounter When Repairing Hospital Light…
603. eXchange 2025 Opens Call for Presentation Abstracts
604. EU/3/21/2479 - orphan designation for treatment of adenosine triphosphate binding cassette…
605. 21 CFR 878.4454: Non-absorbable, hemostatic gauze for temporary internal use.
606. 21 CFR 864.5260: Automated cell-locating device.
607. European Medicines Agency welcomes 1000th orphan designation
608. Simponi - direct healthcare professional communication (DHPC)
609. PSUSA/00010381/202004 - periodic safety update report single assessment
610. New Management Board elects its chairman and approves composition of new scientific…
611. Q&A: Type II variations vs Extension applications
612. European paediatric research network ready to start
613. 21 CFR 14.61: Transcripts of advisory committee meetings.
614. 2012.11.30_ S.O. 2808 (E) GA notification at CDTL Mumbai
615. Bosutinib product-specific bioequivalence guidance
616. EU/3/07/472 - orphan designation for treatment of chronic non-infectious uveitis
617. Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
618. PSUSA/00001997/201804 - periodic safety update report single assessment
619. Budesonide / salmeterol xinafoate - paediatric investigation plan
620. PSUSA/00001834/202304 - periodic safety update report single assessment
621. EMEA-002840-PIP02-22 - paediatric investigation plan
622. EMEA-002812-PIP01-20 - paediatric investigation plan
623. Immunologicals: multidisciplinary
624. 21 CFR 872.5580: Oral rinse to reduce the adhesion of dental plaque.
625. Paediatric Committee (PDCO): 26-29 June 2018
626. Hyperici herba - herbal medicinal product
627. EU/3/16/1691 - orphan designation for treatment of Huntington’s disease
628. EU/3/11/891 - orphan designation for for post-exposure prophylaxis of inhalation anthrax…
629. European Medicines Agency's Management Board elects new chair and vice-chair
630. ema-kinhartoKinharto
631. Start of review of codeine-containing medicines when used for cough and cold in children
632. Exporting active substances manufactured in Great Britain for use in EEA and Northern…
633. Legal requirements for children's medicines
634. ICH E6(R3) good clinical practice workshop with Patients' and Consumers' (PCWP) and…
635. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24…
636. ema-yargesaYargesa
637. The 5th International Clinical Engineering & HTM Congress is Coming! Don't Miss It
638. PSUSA/00009201/202308 - periodic safety update report single assessment
639. Appeal procedure for Orphan Medicinal Product designation
640. Part III: Nonclinical Document
641. PSUSA/00002648/202103 - periodic safety update report single assessment
642. 21 CFR 876.5665: Water purification system for hemodialysis.
643. Inosine Pranobex 500 mg
644. Desidustat Tablet versus Epoetin alfa Injection
645. EU/3/18/2113 - orphan designation for treatment of pseudomyxoma peritonei
646. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - March 2018
647. PSUSA/00001955/201702 - periodic safety update report single assessment
648. EMEA-000032-PIP01-07-M04 - paediatric investigation plan
649. International regulators and WHO join forces to address COVID-19 challenges
650. 21 CFR 862.3700: Propoxyphene test system.
651. ICH E7 Studies in support of special populations: geriatrics - Scientific guideline
652. EMEA-002192-PIP02-17 - paediatric investigation plan
653. 21 CFR 870.2200: Adjunctive cardiovascular status indicator.
654. ICH S10 Photosafety evaluation of pharmaceuticals - Scientific guideline
655. Data requirements to support in-use stability claims for veterinary vaccines - Scientific…
656. ema-tessieTessie
657. EMEA-002323-PIP02-19 - paediatric investigation plan
658. Nafamostat Mesilate for inj
659. ema-strimvelisStrimvelis
660. 3D Printing Helps Solve Ventilator Shortage During COVID-19
661. PSUSA/00002095/202201 - periodic safety update report single assessment
662. Committee for Proprietary Medicinal Products (CPMP) 61st plenary meeting
663. EudraVigilance training on electronic reporting of individual case safety reports in the…
664. AAMI Announces 2020 Winners of BI&T Awards
665. Colesevelam hydrochloride - paediatric investigation plan
666. Draft guidelines: Revised Chapter 4 - Documentation
667. ema-xospataXospata
668. cdsco-rilvegostomig-azd2936Rilvegostomig (AZD2936)
669. 21 CFR 888.4150: Calipers for clinical use.
670. Approach to establish a pharmacological acceptable daily intake (ADI) - Scientific…
671. Announcement of the NMPA on the Release of the Good Manufacturing Practice for Medical…
672. ema-klisyriKlisyri
673. Guidance document on dossier based licensing of Drugs for uniform product licensing in the…
674. EU/3/05/335 - orphan designation for late onset sepsis in premature infants of less or…
675. Human variations electronic application form (eAF) public training
676. EMEA-001552-PIP01-13 - paediatric investigation plan
677. 21 CFR 884.5390: Perineal heater.
678. GL-06-R2 Medical Devices Product Classification Guide (2023 Oct) PUB [PDF, 2.08 MB]
679. PSUSA/00010463/201807 - periodic safety update report single assessment
680. GN-14-R2 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices…
681. Afrezza® Insulin human Inhalation powder (r DNA origin) 4 units/8 units/12 units per…
682. Registration open for PDA/EMA 2011 Conference: 3-5 May 2011
683. Performance enhancers - Scientific guideline
684. Alan Lipschultz: Are You Ready? Two Big Changes on the Horizon for HTM
685. cfr-21-cfr-73-1496-mica21 CFR 73.1496: Mica.
686. Mammography Problems at Aims Diagnostic Imaging in Manahawkin, NJ: FDA Safety…
687. European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare…
688. 21 CFR 74.1334: D&C Red No. 34.
689. Veterinary medicines: highlights of 2020
690. Special Access Scheme (SAS) Applications - Quick Reference Guide
691. EMEA Public Statement on review of recombinant Factor VIII (FVIII) products (Advate…
692. European Medicines Agency workshop with European Union pharmaceutical industry…
693. EU/3/19/2163 - orphan designation for treatment of cystic fibrosis
694. Drug Establishment Licence Application Completion Checklist
695. EMEA-003193-PIP01-22 - paediatric investigation plan
696. Clopidogrel - paediatric investigation plan
697. EU/3/13/1231 - orphan designation for treatment of acute lymphoblastic leukaemia
698. ema-kyomarcKyomarc
699. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April…
700. William Hyman: The FDA’s Self-Imposed Deadlines (Part III)
701. PSUSA/00000084/202211 - periodic safety update report single assessment
702. The annual European Medicines Agency review of the year and outlook for 2015
703. Committee for veterinary medicinal products: 60th meeting
704. Ripasudil HCl Hydrate eq. To Ripasudil Timolol Maleate IP Eq. To to Timolol eye drops
705. Joint Biologics Working Party/ Quality Working Party/ Good Manufacturing and Distributing…
706. Committee for Advanced Therapies (CAT): 13-14 November 2014
707. Management Board meeting: 11 June 2015
708. Notice regarding sub-acute toxicity study report for injectable products for BA/BE study…
709. Hydroxyethyl starch solutions for infusion - referral
710. Evkeeza - opinion on variation to marketing authorisation
711. PSUSA/00000051/202110 - periodic safety update report single assessment
712. 2013 European Medicines Agency / International Federation for Animal Health Europe info…
713. Adverse Events Associated with Use of Enhancement Medical's "Expression" Intranasal Splint…
714. ema-eurifel-rcp-felvEurifel RCP FeLV
715. Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man…
716. Best practices on advance notice of importation process for cosmetics and drugs
717. PSUSA/00003067/202112 - periodic safety update report single assessment
718. EMEA-001501-PIP05-20 - paediatric investigation plan
719. EU/3/12/963 - orphan designation for treatment of cutaneous T-cell lymphoma
720. Committee for veterinary medicinal products: Meeting of 13 to 15 January 2004
721. EU/3/17/1956 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's…
722. VICH GL38 Environmental impact assessments for veterinary medicinal products - Phase II…
723. EMEA-001186-PIP01-11-M03 - paediatric investigation plan
724. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 May 2016
725. ema-lantusLantus
726. 21 CFR 890.3100: Mechanical chair.
727. Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 September 2013
728. European Medicines Agency updates treatment recommendations because of continued Fabrazyme…
729. Management Board meeting: 7 June 2012
730. Seafood Processor, Products, and Importer Inspection Program
731. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
732. PSUSA/00000051/202210 - periodic safety update report single assessment
733. EMEA and EU accession countries meet ahead of enlargement
734. DR_G.S.R. 1057(E) dt_03.11.1988_26A_sr. no 11 (FDC corticosteroids+any other drug) and…
735. EMEA-001358-PIP01-12 - paediatric investigation plan
736. EU/3/09/691 - orphan designation for treatment of inhalation anthrax disease
737. Vildagliptin SR + Metformin Hydrochloride SR IP Sustained release tablets (Phase III)
738. Clarification for import of pre-filled syringe
739. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
740. Trospium Chloride+Xanomeline
741. Emtricitabine/Tenofovir disoproxil Krka d.d.
742. 21 CFR 888.3090: Intraoperative orthopedic strain sensor.
743. ema-anorectics-referralAnorectics - referral
744. New FDA Participation for Two Medical Device Collaborative Communities
745. Digital Dashboard Project Wins 2021 Bright Ideas Award
746. ema-depocyteDepoCyte
747. Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG - a step-by-step guide
748. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - April 2017
749. GN-15-R8 _Guidance on Medical Device Product Registration (2022 Jan) PUB
750. DR_G.S.R.1186(E) dt_07.12.2018_ Approved or permitted color in gelatine capsule Rule127(2)
751. EU/3/11/947 - orphan designation for treatment of acromegaly
752. Fosfomycin-containing medicinal products - referral
753. European Communities (Medical Devices) (Amendment) Regulations 2009 (SI 110/2009)…
754. Details of Importers whose permissions have been suspended / cancelled 2024
755. EU/3/12/1062 - orphan designation for treatment of neuroblastoma
756. Optimising safety information for medicines in Europe throughout product lifecycle
757. EU/3/14/1425 - orphan designation for treatment of spinocerebellar ataxia
758. PSUSA/00010752/202308 - periodic safety update report single assessment
759. EMEA-001607-PIP01-13 - paediatric investigation plan
760. New study suggests risk of birth defects in babies born to women on HIV medicine…
761. Phakic Intraocular Lens Approved for Marketing
762. Strategies to identify and mitigate risks for first-in-human and early clinical trials…
763. Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in…
764. ema-truximaTruxima
765. No consistent evidence of an increased risk of heart problems with testosterone medicines
766. EU/3/02/089 - orphan designation for treatment of juvenile myelomonocytic leukaemia
767. NMPA Announcement on Further Improvement and Optimization of Matters Concerning the…
768. cdsco-efgartigimod-ph20-sc1Efgartigimod PH20 SC1
769. 21 CFR 74.2333: D&C Red No. 33.
770. 10th ESVAC report shows continued decrease in sales of veterinary antibiotics
771. FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva…
772. PSUSA/00000560/202101 - periodic safety update report single assessment
773. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March…
774. cdsco-paltusotinePaltusotine
775. ema-scientific-publicationsScientific publications
776. cdsco-qaw039QAW039
777. EMEA-002864-PIP01-20 - paediatric investigation plan
778. World Hepatitis Day: 28 July 2012
779. cdsco-afliberceptAflibercept
780. ema-noxafilNoxafil
781. 21 CFR 880.5090: Liquid bandage.
782. ema-aplidinAplidin
783. Imbruvica - withdrawal of application for variation to marketing authorisation
784. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14…
785. EU/3/23/2782 - orphan designation for treatment of myelodysplastic syndromes
786. DR_G.S.R. 520(E) dt_31.07.2013_Revoke GSR 379(E)_Reg.Pioglitazone Suspension
787. Joint Drug Information Association/European Forum for Good Clinical Practice/European…
788. Quality of herbal medicinal products/traditional herbal medicinal products - Scientific…
789. ema-yaz-24-4-referralYaz 24+4 - referral
790. FDA Publishes Paper, Schedules Meetings on Pulse Oximeter Use in People with Darker Skin
791. EMEA-002542-PIP03-20 - paediatric investigation plan
792. Increased reporting of side effects of veterinary medicines helps to protect animal and…
793. Hiprabovis IBR Marker Live
794. Voices of HTM: Fernanda Zamudio
795. EMEA-001903-PIP01-15-M01 - paediatric investigation plan
796. Pharmacovigilance Inspectors Working Group
797. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 July 2017
798. Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to…
799. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14…
800. Committee for Herbal Medicinal Products (HMPC): 6-8 July 2026
801. Zulvac BTV - opinion on variation to marketing authorisation
802. Paediatric Committee (PDCO): 23-26 January 2018
803. PSUSA/00009197/201706 - periodic safety update report single assessment
804. 21 CFR 17.18: Interlocutory appeal from ruling of presiding officer.
805. ema-fyzocladFyzoclad
806. EMEA-002350-PIP05-23 - paediatric investigation plan
807. EU/3/10/730 - orphan designation for treatment of hereditary haemorrhagic telangiectasia
808. Voices of HTM: Joe Deater
809. Dossier requirements for anticancer medicinal products for dogs and cats - Scientific…
810. EMEA-000104-PIP01-07 - paediatric investigation plan
811. EU/3/18/2124 - orphan designation for treatment of ataxia telangiectasia
812. EU/3/14/1295 - orphan designation for treatment of plasma cell myeloma
813. PSUSA/00003097/201501 - periodic safety update report single assessment
814. Premixes for medicated feeding stuffs for veterinary use versus powders/granules for oral…
815. EMEA-002017-PIP01-16 - paediatric investigation plan
816. Epilobii herba - herbal medicinal product
817. PIC/S Guideline on Exposure Limits
818. Clinical investigation of medicinal products in the treatment of urinary incontinence…
819. Standards Spotlight: Emergency COVID-19 Guidance from AAMI
820. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - February 2017
821. ema-ema-to-review-inductosEMA to review Inductos
822. EdoxabaN foR IntraCranial Hemorrhage
823. PSUSA/00000435/202308 - periodic safety update report single assessment
824. EMEA-003152-PIP01-21 - paediatric investigation plan
825. Typhoid Vi Conjugate Vaccine
826. Committee for Orphan Medicinal Products: June 2006 meeting
827. 21 CFR 20.102: Court enforcement records.
828. EU/3/17/1931 - orphan designation for treatment in solid organ transplantation
829. EMEA-001755-PIP01-15 - paediatric investigation plan
830. Refusal of orphan designation for treatment of painful HIV-associated neuropathy
831. European Medicines Agency recommends approval of Daklinza in chronic hepatitis C
832. European countries increase commitment to responsible antibiotic use in animals
833. PSUSA/00000774/201411 - periodic safety update report single assessment
834. EU/3/10/751 - orphan designation for prevention of delayed graft function after renal…
835. Decentralised manufacture: The designation step
836. EU/3/22/2717 - orphan designation for treatment of West syndrome
837. PSUSA/00010328/201908 - periodic safety update report single assessment
838. 21 CFR 99.203: Request to extend the time for completing planned studies.
839. Details of Manufacturers whose permissions have been suspended / cancelled 2024
840. EMA recommends measures to minimise risk of serious side effects with Janus kinase…
841. MD&M West Reveals 2022 Educational MedTech Conference with AAMI Participation
842. Izalontamab Brengitecan
843. EMEA-002559-PIP03-19 - paediatric investigation plan
844. DR_G.S.R. 743(E) dt_10.08.1989_ Prohibition of Oestroge and progesterone
845. EU/3/04/257 - orphan designation for treatment of cystic fibrosis
846. SME workshop for micro, small and medium-sized enterprises: Focus on quality for medicines…
847. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
848. Intravascular Air-in-Line and Air Embolism Risks Associated with Infusion Pumps, Fluid…
849. FDA warns of rare but serious skin reactions with the pain reliever/fever reducer…
850. EU/3/16/1820 - orphan designation for treatment of antiphospholipid syndrome
851. ema-medical-devicesMedical devices
852. cdsco-bg00012-and-biib017BG00012 and BIIB017
853. Position paper on the risks associated with the use of herbal products containing…
854. EMEA-001286-PIP01-12 - paediatric investigation plan
855. Third joint meeting of the EMA Scientific Committees' Working Party with Patients' and…
856. 2021.06.22_SO 2451(E)Notification of Sumir Rai Bhalla as GA for CDL Kasauli
857. Ted Cohen: Let's Actively Reduce Security Hazards Through Better Patch Management
858. FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the…
859. Paediatric Committee (PDCO): 9-11 June 2010
860. LY900014 (Insulin Lispro)
861. ema-ozespaOzespa
862. EMEA-001429-PIP01-13-M07 - paediatric investigation plan
863. Committee for Medicinal Products for Human Use (CHMP): 25-28 January 2016
864. Medicinal Products (Prescription and Control of Supply) (Amendment) (No 3) Regulations…
865. Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional…
866. Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 April…
867. Notice Regarding Classification of Medical devices and in Vitro diagnostic Medical devices…
868. tga-organisation-detailsOrganisation details
869. Benidipine Hydrochloride + Metoprolol Succinate eq. to Metoprolol tartrate IP Film coated…
870. Workshop on health-related quality of life in oncology
871. Notice Order regarding Examination of Safety and efficacy of FDCs licensed for manufacture…
872. ema-entrestoEntresto
873. Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting…
874. 21 CFR 876.5630: Peritoneal dialysis system and accessories.
875. Infliximab - paediatric investigation plan
876. Minutes of the meeting of 14th CBBDTEC
877. Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 May 2026
878. EMEA-001882-PIP02-16-M02 - paediatric investigation plan
879. 21 CFR 50.20: General requirements for informed consent.
880. European Medicines Agency recommends contraindications for suppositories containing…
881. EMEA-002068-PIP01-16-M04 - paediatric investigation plan
882. PSUSA/00002117/202211 - periodic safety update report single assessment
883. 21 CFR 882.1240: Echoencephalograph.
884. Committee for Herbal Medicinal Products (HMPC): 5-7 July 2021
885. cdsco-lemborexantLemborexant
886. ema-fasenraFasenra
887. EMA press briefing to inform on CHMP discussion on booster doses
888. ema-preotactPreotact
889. ema-nuflor-referralNuflor - referral
890. cdsco-bempedoic-acidBempedoic acid
891. ema-braftoviBraftovi
892. ema-valdynValdyn
893. European Medicines Agency recommends approval of Mekinist for the treatment of melanoma
894. ema-executive-directorExecutive Director
895. PSUSA/00001932/201806 - periodic safety update report single assessment
896. SPOR and xEVMPD Stakeholder Engagement Webinars : Organisation Management Service (OMS)
897. Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 (SI…
898. Medicines for the treatment of pain in children – EMEA workshop28 october 2004
899. European Medicines Agency website unavailable Saturday 28 September
900. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance plenary meeting
901. European Medicines Agency recommends restricting Trobalt to last-line therapy in partial…
902. PSUSA/00010130/201502 - periodic safety update report single assessment
903. Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft…
904. PSUSA/00000260/201909 - periodic safety update report single assessment
905. EMEA-002808-PIP01-20 - paediatric investigation plan
906. cdsco-amivantamabAmivantamab
907. EMEA-000918-PIP01-10 - paediatric investigation plan
908. ema-votrientVotrient
909. November 3rd 2017 GSR 1368(E)
910. Pharmacovigilance Risk Assessment Committee (PRAC): 12-15 March 2019
911. Guideline on medicines for the treatment of amyotrophic lateral sclerosis released for a…
912. cdsco-marzeptacog-alfaMarzeptacog Alfa
913. ema-thelinThelin
914. PSUSA/00001594/202306 - periodic safety update report single assessment
915. Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy
916. European Medicines Agency - Parenteral Drug Association (PDA) bilateral meeting
917. 21 CFR 812.20: Application.
918. Regulatory guidance for the use of health-related quality of life (HRQL) measures in the…
919. EMEA-000935-PIP01-10 - paediatric investigation plan
920. Polyhydroxy acids, including PLA, PGA, and other blends and copolymers, the most common…
921. EU/3/21/2559 - orphan designation for treatment of amyotrophic lateral sclerosis
922. Minutes of meeting of CDSCO with stakeholders for obtaining Import License without…
923. ema-xydalbaXydalba
924. EU/3/12/1000 - orphan designation for treatment of pancreatic cancer
925. EU/3/20/2294 - orphan designation for treatment of idiopathic pulmonary fibrosis
926. Pharmacovigilance Risk Assessment Committee: one year of public-health promotion and…
927. Changes to variation rules start to apply from 2 November 2012
928. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 May 2022
929. ema-sitagliptin-sunSitagliptin SUN
930. EU/3/15/1482 - orphan designation for treatment of choroideraemia
931. EU/3/01/031 - orphan designation for treatment of myelodysplastic syndromes
932. ema-hycamtinHycamtin
933. Meeting of the EMEA working party on herbal medicinal products 30 and 31 October 2000
934. Committee for Orphan Medicinal Products (COMP): 3-5 December 2024
935. Pegylated Erythropoietin, 100 mcg/0.3 ml injection (PEG-EPO)
936. EMEA-000429-PIP01-08-M04 - paediatric investigation plan
937. cdsco-fitusiranFitusiran
938. 21 CFR 872.6660: Porcelain powder for clinical use.
939. 21 CFR 801.5: Medical devices; adequate directions for use.
940. PSUSA/00001406/201708 - periodic safety update report single assessment
941. ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential…
942. PSUSA/00001990/201502 - periodic safety update report single assessment
943. cdsco-cagrisemaCagriSema
944. Drug Safety Update: monthly PDF newsletter: Drug Safety Update April 2020
945. 21 CFR 862.1510: Nitrite (nonquantitative) test system.
946. EU/3/04/187 - orphan designation for prevention of hepatitis-B re-infection following…
947. AS G0010.1.001: Auditor Training
948. Notifications: Regulatory and procedural guidance
949. EMEA-001345-PIP01-12 - paediatric investigation plan
950. PRAC recommends suspension of diacerein-containing medicines
951. EMEA-002839-PIP01-20-M01 - paediatric investigation plan
952. Imatinib product-specific bioequivalence guidance
953. Alectinib product-specific bioequivalence guidance
954. Centres of Excellence for Regulatory Science and Innovation (CERSIs)
955. EMEA-001460-PIP01-13-M05 - paediatric investigation plan
956. EU/3/16/1729 - orphan designation for treatment of lysinuric protein intolerance
957. Sofosbuvir / Velpatasvir FDC
958. European Medicines Agency increases transparency of ongoing applications for human…
959. PSUSA/00009159/201703 - periodic safety update report single assessment
960. ema-dexmedetomidine-accordDexmedetomidine Accord
961. EMEA-001766-PIP01-15-M05 - paediatric investigation plan
962. ema-ventavisVentavis
963. EU/3/11/898 - orphan designation for treatment of chronic non-infectious uveitis
964. 21 CFR 866.5370: Cohn fraction V immunological test system.
965. PEG (polyethylene glycol), used broadly and as a coating for stents and catheters
966. Scientific and technical recommendations: Veterinary Medicines Regulation
967. Glucophage/Glucophage Forte/Risidon/Dianben - referral
968. EMEA-001870-PIP01-15-M02 - paediatric investigation plan
969. cdsco-amikacin-sulphateAmikacin Sulphate
970. Europe to boost international cooperation on generics
971. Enpr-EMA Coordinating Group and networks meeting
972. EMEA-002800-PIP01-20 - paediatric investigation plan
973. NMPA Announcement on Issuing the Interim Provisions on the Management of Designated…
974. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 May 2017
975. Pharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped…
976. 21 CFR 888.3170: Elbow joint radial (hemi-elbow) polymer prosthesis.
977. ema-adtralzaAdtralza
978. Drugs Alert for the month of September 2013
979. 21 CFR 878.4300: Implantable clip.
980. Inhaled Itracoanzole Dry Powder for inhalation 10 mg capsule (PUR 1900)
981. PSUSA/00010288/202005 - periodic safety update report single assessment
982. 21 CFR 13.20: Submissions to a Board.
983. EU/3/05/345 - orphan designation for treatment of Wiskott-Aldrich syndrome
984. Safety Public Assessment Reports
985. Methylprednisolone injection for cattle - referral
986. ema-amlovita-referralAmlovita - referral
987. EU/3/16/1684 - orphan designation for treatment of Crigler-Najjar syndrome
988. ema-ucedaneUcedane
989. ema-sileoSileo
990. Annex 7 to the Good manufacturing practices guide - Selected non-prescription drugs…
991. Mary Logan: Risk Management Is Everyone's Business
992. ema-combivirCombivir
993. cdsco-rusfertide-ptg-300Rusfertide PTG-300
994. National List of Essential Medicines 2015
995. General Court upholds European Medicines Agency decision to refuse paediatric waiver for…
996. Methylene Blue - Updated information about the drug interaction between methylene blue…
997. Zoonotic Influenza Vaccine Seqirus