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Global regulations and guidance

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

  1. PSUSA/00010206/202105 - periodic safety update report single assessment
  2. Regulations for Management of Medical Devices Technicians
  3. Vildagliptin SR + Dapagliflozin + film coated bilayered tablets (Phase III)
  4. 21 CFR 26.78: Agreements with other countries.
  5. 21 CFR 872.3840: Endodontic silver point.
  6. FDA Seeks Feedback on Medical Device Cybersecurity Threat Communication
  7. Third European Medicines Agency and Nuclear Medicines Europe bilateral meeting
  8. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 March 2015
  9. Committee for veterinary medicinal products: Meeting of 11 to 13 February 2003
  10. EMEA-002365-PIP01-18 - paediatric investigation plan
  11. AAMI 2025 Voting: Board Directors, Vice Chairs, and Re-elections
  12. Creating the CMI summary page - Guidance for sponsors
  13. PSUSA/00002643/201508 - periodic safety update report single assessment
  14. EU/3/06/373 - orphan designation for treatment of primary insulin-like growth factor-1…
  15. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  16. cdsco-morf-057MORF-057
  17. 21 CFR 884.4120: Gynecologic electrocautery and accessories.
  18. Cancel a medicine's marketing authorisation or other licence
  19. ema-omlycloOmlyclo
  20. Checklist for Form MD-22MD
  21. Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In…
  22. Speech at the First GHWP (Guangzhou) Academy Training
  23. EMEA-002903-PIP01-20 - paediatric investigation plan
  24. Haldol Decanoate and associated names - referral
  25. Macugen - withdrawal of application for variation to marketing authorisation
  26. Committee for Herbal Medicinal Products (HMPC): 21-23 September 2026
  27. 21 CFR 868.5810: Airway connector.
  28. 21 CFR 14.171: Utilization of an advisory committee on the initiative of FDA.
  29. ema-garenoxacin-mesylateGarenoxacin mesylate
  30. ema-eladynosEladynos
  31. 21 CFR 862.2150: Continuous flow sequential multiple chemistry analyzer for clinical use.
  32. Development pharmaceutics for veterinary medicinal products - Scientific guideline
  33. EU/3/18/2008 - orphan designation for treatment of amyotrophic lateral sclerosis
  34. EMEA-000467-PIP01-08-M15 - paediatric investigation plan
  35. ema-innovax-iltInnovax-ILT
  36. William Hyman: The FDA's Advice on Archived Data Reliability
  37. EMEA-000694-PIP01-09-M08 - paediatric investigation plan
  38. ema-azacitidine-kabiAzacitidine Kabi
  39. EU/3/09/637 - orphan designation for treatment of 5-fluorouracil overdose
  40. ema-vizimproVizimpro
  41. PSUSA/00000485/202111 - periodic safety update report single assessment
  42. UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: August 13, 2025 General and…
  43. Updates to CIR 520/2012 - Information for UK Marketing Authorisation Holders
  44. Paediatric Committee (PDCO): 11-14 October 2022
  45. Glimepiride IP + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin tablets (Phase…
  46. ema-epostimEpostim
  47. 21 CFR 876.4370: Gastroenterology-urology evacuator.
  48. EMEA-001411-PIP01-12-M04 - paediatric investigation plan
  49. EMEA-001139-PIP01-11-M02 - paediatric investigation plan
  50. EU/3/21/2503 - orphan designation for treatment of tuberous sclerosis
  51. ema-qutenzaQutenza
  52. Guidance on CTGTP Registration and Variation Applications in Singapore
  53. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June…
  54. FDA Delays UDI Enforcement in Midst of COVID-19
  55. Subcutaneous Secukinumab
  56. EU/3/18/1974 - orphan designation for treatment of acute myeloid leukaemia
  57. EU/3/11/945 - orphan designation for treatment of acute liver failure
  58. 24th October 2013 (GSR 703 (E)
  59. cfr-21-cfr-26-0-general21 CFR 26.0: General.
  60. First 2017 meeting of the coordinating group of the European network of paediatric…
  61. 21 CFR 872.3200: Resin tooth bonding agent.
  62. Paediatric Committee (PDCO): 20-23 June 2023
  63. ema-stocrinStocrin
  64. PSUSA/00000755/201801 - periodic safety update report single assessment
  65. ema-stivargaStivarga
  66. EU/3/17/1832 - orphan designation for treatment of fragile X syndrome
  67. ema-solirisSoliris
  68. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30…
  69. On the Standard Review Timeline for New Drug Applications
  70. Innovative Product Microsatellite Instability (MSI) Detection Kit (Fluorescent…
  71. ema-jyselecaJyseleca
  72. PSUSA/00002157/202112 - periodic safety update report single assessment
  73. ema-opulisOpulis
  74. Management Board meeting: 5-6 October 2016
  75. Committee for Medicinal Products for Human Use (CHMP): 19-22 August 2024
  76. 21 CFR 16.95: Administrative decision and record for decision.
  77. PRAC re-examines diacerein and recommends that it remain available with restrictions
  78. 21 CFR 866.3270: Flavobacterium spp. serological reagents.
  79. NSQ ALERT FOR THE MONTH OF JANUARY-2025
  80. Labelling of investigational and auxiliary products in clinical trials
  81. Patient information leaflets for blind and partially-sighted patients: Provision of…
  82. Locatim (previously Serinucoli)
  83. EU/3/21/2543 - orphan designation for treatment of glioma
  84. PSUSA/00001151/202103 - periodic safety update report single assessment
  85. Meeting of the paediatric diabetes mellitus expert group
  86. 21 CFR 862.3610: Methamphetamine test system.
  87. Retired IAHCSMM Leader Betty Hanna Remembered
  88. PSUSA/00000964/201412 - periodic safety update report single assessment
  89. Q&A clinic on Product Management Service (PMS) product user interface and application…
  90. Action Plan for Medical Devices - Progress Report Card: April 2020
  91. Paediatric Committee (PDCO): 11-13 February 2015
  92. Cilnidipine IP 20mg + Telmisartan IP 40mg film coated tablet
  93. VA New York Harbor HTM Response to COVID-19
  94. EU/3/23/2796 - orphan designation for treatment of myelodysplastic syndromes
  95. ema-vizarsinVizarsin
  96. ema-paxenePaxene
  97. EU/3/15/1542 - orphan designation for treatment of diffuse large B-cell lymphoma
  98. EMEA-001140-PIP02-15 - paediatric investigation plan
  99. Modelling and simulation: questions and answers
  100. PSUSA/00001807/202005 - periodic safety update report single assessment
  101. FDA warns about new impulse-control problems associated with mental health drug…
  102. DR_G.S.R. 86(E) dt_13.02.2014_Revoke GSR378(E)_Reg. Suspension of Analgin
  103. PSUSA/00002378/201501 - periodic safety update report single assessment
  104. Clinical trials for medicines: collection, verification, & reporting of safety events
  105. Glimepirida Parke-Davis - referral
  106. 21 CFR 880.6185: Cast cover.
  107. Experimental Ebola treatments still at early stage of development
  108. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26…
  109. cdsco-ajanta-pharmaAjanta Pharma
  110. 21 CFR 801.35: Voluntary labeling of a device with a unique device identifier.
  111. 21 CFR 1.1440: What process will FDA follow when waiving a requirement of this subpart on…
  112. 21 CFR 862.1030: Alanine amino transferase (ALT/SGPT) test system.
  113. EU/3/10/790 - orphan designation for treatment idiopathic pulmonary fibrosis
  114. ema-desloratadine-tevaDesloratadine Teva
  115. Adrenaline Auto-Injectors (AAIs) safety campaign
  116. EMEA-002042-PIP01-16 - paediatric investigation plan
  117. ema-mateverMatever
  118. Committee for Advanced Therapies (CAT) and the International Society for Cellular Therapy…
  119. EU/3/07/500 - orphan designation for treatment of retinitis pigmentosa
  120. Second Industry Standing Group (ISG) meeting
  121. EMEA-000142-PIP02-09-M11 - paediatric investigation plan
  122. EU/3/15/1519 - orphan designation for treatment of Duchenne muscular dystrophy
  123. FDA reinforces safety information about serious low blood sugar levels and mental health…
  124. Drug Safety Update: monthly PDF newsletter: Drug Safety Update December 2022
  125. Technical anonymisation group
  126. August 30.08.2013 GSR 588 (E)
  127. 21 CFR 884.5310: Condom with spermicidal lubricant.
  128. ema-kanjintiKanjinti
  129. Procedural update on submission of Type I variations to EMA in March, April and May 2019
  130. Fifth Nitrosamine Implementation Oversight Group (NIOG) meeting
  131. 21 CFR 880.6710: Medical ultraviolet water purifier.
  132. 21 CFR 74.3054: D&C Black No. 4.
  133. 21 CFR 872.4850: Ultrasonic scaler.
  134. Classification of changes for veterinary medicines
  135. New Member Organizations: July 2020
  136. EMEA-001321-PIP01-12 - paediatric investigation plan
  137. Leuprolide acetate for injectable suspension, 30 mg
  138. PSUSA/00000095/201612 - periodic safety update report single assessment
  139. cdsco-fiaspFIASP
  140. Notice regarding consideration of the directions of Hon'ble SC India in the Case of 344…
  141. cfr-21-cfr-876-1-scope21 CFR 876.1: Scope.
  142. Simulect - direct healthcare professional communication (DHPC)
  143. Ebronucimab Injection Approved for Marketing by China NMPA
  144. PSUSA/00001997/201504 - periodic safety update report single assessment
  145. Elagolix Tablets 200 mg
  146. cdsco-everolimus-radoo1Everolimus RADOO1
  147. Management Board: Meetings 2015
  148. PSUSA 00000048/201506 - periodic safety update report single assessment
  149. EU/3/20/2315 - orphan designation for treatment of mucopolysaccharidosis VI…
  150. European Medicines Agency passes milestone of 40th positive opinion for an orphan…
  151. Actos (pioglitazone) - Ongoing Safety Review of Actos (pioglitazone) and Potential…
  152. EU/3/08/606 - orphan designation for treatment of Behçet's Disease
  153. Telemedicine Policy: U.S. States Took a More Deliberate and Cautious Approach in 2023…
  154. European Medicines Agency launches survey to gather feedback on SME programme
  155. Paclitaxel Coated PTA Balloon Catheter Approved for Marketing
  156. Public Statement on Viramune (Nevirapine) - Severe and Life-Threatening Cutaneous and…
  157. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 16-19…
  158. ema-gamifantGamifant
  159. Quality of Fecal Microbiota Transplantation (FMT) Products at the Initial Development…
  160. Evaluation of bovine spongiform encephalopathies (BSE) - risk via the use of materials of…
  161. EU/3/14/1273 - orphan designation for treatment of glioma
  162. Tylosin injection for mastitis - referral
  163. Introducing the 2021 Nominees for Board of Directors & Nominating Committee
  164. ema-coversyl-referralCoversyl - referral
  165. 2018.07.19_Draft_GSR 660(E)_Amendment in Environmental requirements for mfg. of Medical…
  166. PSUSA/00001213/201501 - periodic safety update report single assessment
  167. EMEA-001090-PIP02-21 - paediatric investigation plan
  168. EMEA-002995-PIP01-21 - paediatric investigation plan
  169. Reporting adverse incidents: joint replacement implants
  170. Toujeo (previously Optisulin)
  171. Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting
  172. Basic Principles of Risk-based Monitoring
  173. PSUSA/00003047/202012 - periodic safety update report single assessment
  174. PSUSA/00002847/202107 - periodic safety update report single assessment
  175. PSUSA/00003078/202107 - periodic safety update report single assessment
  176. PSUSA/00010298/201508 - periodic safety update report single assessment
  177. cdsco-dato-dxdDato-DXd
  178. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
  179. Improving patient safety through more proactive risk management
  180. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - May 2018
  181. C-TB with QuantiFERON-TB Gold Plus and 2.T.U. Tuberculin PPD RT23
  182. European Medicines Agency and US Food and Drug Administration strengthen collaboration in…
  183. PSUSA/00001057/201803 - periodic safety update report single assessment
  184. Committee for veterinary medicinal products: 72nd meeting
  185. Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney…
  186. 21 CFR 868.5310: Carbon dioxide absorber.
  187. PSUSA/00001696/201605 - periodic safety update report single assessment
  188. AAMI News September 2019, Volume 54, Issue 9
  189. Circular for Licensing of Class C D medical devices dated 12.04.2023
  190. New fees for marketing authorisation applications in force
  191. PSUSA/00003162/201701 - periodic safety update report single assessment
  192. EU/3/23/2831 - orphan designation for treatment of Leigh syndrome
  193. Kawasaki M. Recent Regulatory Trends for Biosimilars in Japan. Global Bio Conference 2026…
  194. PSUSA/00010430/201711 - periodic safety update report single assessment
  195. Active pharmaceutical ingredients: Japan joins international collaboration on GMP…
  196. Raltitrexed - paediatric investigation plan
  197. EU/3/15/1483 - orphan designation for treatment of perinatal asphyxia
  198. ema-ingelvac-circoflexIngelvac CircoFLEX
  199. Committee for veterinary medicinal products: 80th meeting
  200. VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food…
  201. DR_G.S.R. 41(E) dt_17.01.2017_Notification for Hazira port and ICD Khodiyar Gandhi nagar
  202. Two new combination therapies against chronic hepatitis C
  203. Committee for Proprietary Medicinal Products (CPMP) 52nd plenary meeting
  204. Colour change for insulin injection Fiasp to avoid mix ups with Tresiba
  205. PSUSA/00002569/202309 - periodic safety update report single assessment
  206. Guide to the exceptional importation and sale of drugs in response to drug shortages…
  207. 2025.10.16_ G.S.R. 758(E)_ Inclusion of additional items under CLAA in Drugs Rules 1945
  208. Committee for Proprietary Medicinal Products (CPMP) 48th plenary meeting
  209. Meeting of DTAB Sub Committee through WebEx (Video Conference) w.e.f. 19.04.2021 to…
  210. Granting permission to manufacturers of industrial oxygen to manufacture oxygen for…
  211. ema-benlystaBenlysta
  212. EMEA-001516-PIP01-13 - paediatric investigation plan
  213. Medical devices: UK approved bodies: DEKRA Certification UK Ltd Medical Devices Scope
  214. Notice-dated 11.12.2012: Advisory notice on Clinical Trial
  215. Defect in Herceptin vials identified but supply for patients is maintained
  216. PSUSA-00001694-202103 - periodic safety update report single assessment
  217. 21 CFR 880.5075: Elastic bandage.
  218. ema-reyatazReyataz
  219. PSUSA/00001773/202006 - periodic safety update report single assessment
  220. Jcovden (previously COVID-19 Vaccine Janssen) - direct healthcare professional…
  221. Team-NB Position Paper IVDR Significant changes V1
  222. Disposal of unserviceable/obsolete item of CDSCO dated 21.12.2018
  223. Quality System Requirements For Pharmaceutical Inspectorates
  224. PSUSA/00001450/202211 - periodic safety update report single assessment
  225. ema-erleadaErleada
  226. Ch. 2 - FDA Authority
  227. EMEA-001521-PIP01-13-M06 - paediatric investigation plan
  228. ema-entyvioEntyvio
  229. 21 CFR 876.5820: Hemodialysis system and accessories.
  230. EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
  231. 21 CFR 822.30: May I request exemption from the requirement to conduct postmarket…
  232. Mary Logan: How You Can Improve Reprocessing
  233. Lasers, intense light source systems and LEDs: Lasers, intense light source systems and…
  234. Send a question to the European Medicines Agency
  235. EU/3/13/1176 - orphan designation for treatment of non-traumatic osteonecrosis
  236. Guideline on Ensuring the Quality and Safety of Gene Therapy Products
  237. Glucose monohydrate - paediatric investigation plan
  238. PSUSA/00002063/201504 - periodic safety update report single assessment
  239. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 November 2011
  240. cdsco-concizumabConcizumab
  241. Guidance Document- Submission of Risk Management Plans and Follow-up Commitments
  242. EU/3/18/2087 - orphan designation for treatment of hereditary haemorrhagic telangiectasia
  243. Science and innovation for better medicines
  244. EMEA-002871-PIP01-20 - paediatric investigation plan
  245. EU/3/15/1433 - orphan designation for treatment of sickle cell disease
  246. DR_G.S.R. 30(E) dt_20.01.2022_Amendment of Sch K for Liquid Antiseptics at Sr. no 39 in…
  247. European Agency for the evaluation of medicinal products: Committee for Proprietary…
  248. 21 CFR 866.3120: Chlamydia serological reagents.
  249. EMA and ECDC update on COVID-19
  250. PSUSA/00002151/202008 - periodic safety update report single assessment
  251. 21 CFR 14.174: Advice and recommendations in writing.
  252. PSUSA/0000936/201806 - periodic safety update report single assessment
  253. As New FDA Draft Guidance Broadens Scope of PCCPs, AI Remains a Priority
  254. Questions and Answers (Q&A) on the Implementation of Risk-Based Prevention of…
  255. Lavandulae aetheroleum - herbal medicinal product
  256. 21 CFR 73.1326: Chromium hydroxide green.
  257. PSUSA/00001660/201801 - periodic safety update report single assessment
  258. European Medicines Agency launches a new version of EudraCT
  259. Clopidogrel BGR (previously Zylagren)
  260. Information Regarding Explanations to Driver Mutations in the Development of Anti-cancer…
  261. Proactive publication of clinical-trial data – discussing the way forward
  262. Committee for medicinal products for veterinary use: Meeting of 16 - 18 January 2007
  263. Annex A1 Guidance on Process Validation Scheme for Solid Oral Dosage Products
  264. Ronapreve - opinion on variation to marketing authorisation
  265. EMEA-000498-PIP01-08-M10 - paediatric investigation plan
  266. 21 CFR 882.5705: Digital therapy device to reduce sleep disturbance for psychiatric…
  267. PSUSA/00001331/201809 - periodic safety update report single assessment
  268. 21 CFR 864.6600: Osmotic fragility test.
  269. cdsco-ziltivekimabziltivekimab
  270. Leadless cardiac pacemaker therapy: guidance from an MHRA Expert Advisory Group
  271. Committee for Advanced Therapies (CAT): 16-17 April 2015
  272. DNA and host cell protein impurities, routine testing versus validation studies…
  273. Notice regarding implementation of gazette notification vide GSR 754(E) dated 30.09.2022
  274. EMEA-001141-PIP01-11 - paediatric investigation plan
  275. PSUSA/00001809/202201 - periodic safety update report single assessment
  276. PSUSA/00010312/201701 - periodic safety update report single assessment
  277. EU/3/12/952 - orphan designation for treatment of squamous-cell carcinoma of the head and…
  278. ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization…
  279. Registered complementary and OTC medicines application and submissions
  280. 21 CFR 888.3730: Toe joint phalangeal (hemi-toe) polymer prosthesis.
  281. Committee for Advanced Therapies adopts first classification recommendation for an…
  282. European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim
  283. Valproate - direct healthcare professional communication (DHPC)
  284. Haematology Working Party documents
  285. 35th meeting of the Committee for Orphan Medicinal Products
  286. PSUSA/00001493/201612 - periodic safety update report single assessment
  287. EU/3/12/1033 - orphan designation for treatment of Fabry disease
  288. ema-nilotinib-accordNilotinib Accord
  289. PSUSA/00002656/201902 - periodic safety update report single assessment
  290. EU/3/12/1017 - orphan designation for treatment of recessive X-linked ichthyosis
  291. ema-protelosProtelos
  292. 21 CFR 74.1205: D&C Green No. 5.
  293. PSUSA/00001902/202301 - periodic safety update report single assessment
  294. EMEA-002705-PIP01-19-M01 - paediatric investigation plan
  295. 21 CFR 73.1375: Pyrogallol.
  296. New vaccine for prevention of Ebola virus disease recommended for approval in the European…
  297. cdsco-may-5-2014-g-s-r-312-eMay 5.2014 G.S.R.312(E)
  298. ema-iressaIressa
  299. ICH Q14 Analytical procedure development - Scientific guideline
  300. Luspatercept powder for solution for injection: 25 mg and 75 mg
  301. Guidance Document Software as a Medical Device (SaMD): Classification Examples
  302. European Union (EU) International Organisation for Standardisation (ISO) identification of…
  303. Povidone-Iodine Nail Solution
  304. I-HTM Bridges the Gap Through Innovative Solutions and Collaboration
  305. Information on transitional arrangements for pharmacovigilance legislation published
  306. Treprostinil SciPharm Sàrl
  307. EU/3/20/2297 - orphan designation for treatment of metachromatic leukodystrophy
  308. cdsco-july-17-2012-gsr-575-eJuly 17, 2012 (GSR 575(E))
  309. EMEA-000940-PIP01-10 - paediatric investigation plan
  310. Reinforcing communication with patients and healthcare professionals
  311. EU/3/17/1910 - orphan designation for treatment of tuberous sclerosis
  312. Dolutegravir product-specific bioequivalence guidance
  313. 21 CFR 882.1500: Esthesiometer.
  314. EU/3/16/1750 - orphan designation for treatment of noninsulinoma pancreatogenous…
  315. cdsco-lnp023LNP023
  316. EU/3/13/1144 - orphan designation for treatment of mucopolysaccharidosis type IIIB…
  317. Natpar - direct healthcare professional communication (DHPC)
  318. EU/3/12/1058 - orphan designation for treatment of glioma
  319. Register for the Distance Selling logo
  320. Amendment of Notice Announcement : September 15, 2016 National Mammography Quality…
  321. 21 CFR 1.393: What information must FDA include in the detention order?
  322. EMEA-001100-PIP01-10 - paediatric investigation plan
  323. Nelarabine Injection 250mg/50mL (5mg/mL)
  324. Application of the Falsified Medicines Directive: Safety Features in Northern Ireland
  325. EMEA-000181-PIP01-08-M06 - paediatric investigation plan
  326. ema-tecnemab-k1Tecnemab K1
  327. TEAM-NB-Position-Paper-VisionOnRevisionMedicalDeviceRegulations
  328. AS P0010.004 Auditing Organization (AO) Application For Recognition Procedure
  329. Involving patients in discussions on benefits and risks of medicines
  330. EMEA-003035-PIP02-21 - paediatric investigation plan
  331. PSUSA/00002910/202301 - periodic safety update report single assessment
  332. EU/3/11/867 - orphan designation for treatment of acute myeloid leukaemia
  333. Bevacizumab Injection, 1.25mg/50µL
  334. EMEA-001229-PIP01-11-M03 - paediatric investigation plan
  335. Committee for Medicinal Products for Human Use (CHMP) Biologics Working Party (BWP)…
  336. EMEA-001214-PIP08-21 - paediatric investigation plan
  337. 21 CFR 880.6260: Filtering facepiece respirator for use by the general public in public…
  338. Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
  339. EU/3/18/2030 - orphan designation for treatment of Duchenne muscular dystrophy
  340. Focus group on veterinary pharmacovigilance reporting in aquaculture
  341. Refusal of orphan designation for treatment of active phase of Peyronie's disease
  342. Andrographidis paniculatae folium - herbal medicinal product
  343. 25.01.2019_Final GSR 47(E)_Exemption of 100mL single use sterile parenteral solutions for…
  344. Committee for Orphan Medicinal Products (COMP): 5-7 November 2019
  345. ema-victrelisVictrelis
  346. EMEA-003172-PIP01-21 - paediatric investigation plan
  347. PSUSA/00002166/202311 - periodic safety update report single assessment
  348. PSUSA/00010749/202103 - periodic safety update report single assessment
  349. 21 CFR 874.1820: Surgical nerve stimulator/locator.
  350. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg + Metoprolol Succinate IP…
  351. Fifth European Medicines Agency - EuropaBio bilateral meeting
  352. Manufacturer’s Online Reporting Environment (MORE)
  353. March 28-29, 2023: Joint Meeting of the Drug Safety and Risk Management Advisory Committee…
  354. 21 CFR 801.15: Medical devices; prominence of required label statements; use of symbols in…
  355. 21 CFR 807.87: Information required in a premarket notification submission.
  356. EMEA-003352-PIP01-22 - paediatric investigation plan
  357. EMEA-000018-PIP01-07-M14 - paediatric investigation plan
  358. Paediatric Committee (PDCO): 12-14 October 2011
  359. EMEA-001119-PIP03-19-M03 - paediatric investigation plan
  360. PSUSA/00002307/202306 - periodic safety update report single assessment
  361. Team-NB-IVDConfirmationLetterTemplate-V2-20240710
  362. Notice for meeting of stake holders-Regarding ONLINE SUGAM PORTAL for blood product
  363. EU/3/10/728 - orphan designation for treatment of progressive supranuclear palsy
  364. Unique Cybersecurity Threats Affecting Machine Learning–Based Technologies
  365. Effective field safety notices (FSNs): guidance for manufacturers of medical devices
  366. First Direct-to-Consumer Hearing Aid Receives FDA Clearance
  367. Extension of Expert Committee
  368. European Medicines Agency closed 24 December 2014 to 4 January 2015
  369. Opdivo - withdrawal of application for variation to marketing authorisation
  370. Committee for Advanced Therapies (CAT): 16-17 January 2014
  371. Drug Alert list for month of May 2015
  372. Anti-Covid-19 mAbs cocktail drug product
  373. Establishment Standards for Cosmetics Manufactory
  374. PSUSA/00000936/201506 - periodic safety update report single assessment
  375. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical…
  376. ema-resolorResolor
  377. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15…
  378. EMEA-000171-PIP01-07 - paediatric investigation plan
  379. EMEA-001666-PIP01-14-M01 - paediatric investigation plan
  380. 21 CFR 886.1605: Perimeter.
  381. Wrist Wearables May Help Predict Post-Trauma Mental Health Symptoms
  382. Novartis Europharm Ltd withdraws its marketing authorisation application for Joulferon…
  383. Third Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical…
  384. PSUSA/00001834/201604 - periodic safety update report single assessment
  385. EU/3/16/1773 - orphan designation for treatment of cytomegalovirus infection in patients…
  386. Interim NB-Med consensus version on “Testing during unannounced Audits” V…
  387. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 February 2024
  388. 21 CFR 74.1336: D&C Red No. 36.
  389. 21 CFR 890.3640: Arm sling.
  390. 21 CFR 866.3175: Cytomegalovirus serological reagents.
  391. EU/3/19/2203 - orphan designation for treatment of Netherton syndrome
  392. Notice Uploading of applications through Sugam Portal in accordance with New Drugs and…
  393. Personalised medical devices (including 3D-printed devices)
  394. EU-US collaboration to boost medicine development for rare diseases
  395. Committee for medicinal products for veterinary use: Meeting of 13-15 February 2007
  396. EU/3/21/2402 - orphan designation for treatment of sickle cell disease
  397. How tests and testing kits for coronavirus (COVID-19) work: For industry and…
  398. cdsco-afatinib-for-patientsAfatinib for Patients
  399. EU/3/10/742 - orphan designation for treatment of acute myeloid leukaemia
  400. EMA to launch new corporate website on 27 September 2018
  401. EMEA-002213-PIP01-17 - paediatric investigation plan
  402. cdsco-medi4736-augMEDI4736 aug
  403. EMEA-001055-PIP02-21 - paediatric investigation plan
  404. ema-orfadinOrfadin
  405. Sphaeranthus Indicus Extract
  406. ema-referrals-proceduresReferrals procedures
  407. Drug Alert list for month of November 2016
  408. Committee for Medicinal Products for Veterinary Use (CVMP): 17-18 March 2020
  409. SAR341402 Mix 70/30 to NovoMix®3
  410. DR_G.S.R. 145(E) dt_17.02.2017_Revoke of suspension on Letrozole
  411. Mutual reliance between the United States Food and Drug Administration and the European…
  412. Identifying and Filling Skills Gap in the HTM Workforce: It’s Time to Scrap Spreadsheets
  413. Ethyl Eicosapent soft gelatin capsules
  414. PSUSA/00010667/202306 - periodic safety update report single assessment
  415. 21 CFR 872.3490: Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid…
  416. eXtended EudraVigilance medicinal product dictionary face-to-face training course, Prague
  417. 21 CFR 874.1050: Audiometer.
  418. GHWP Chair and AMDF Chair held online meeting
  419. EMEA-001355-PIP01-12 - paediatric investigation plan
  420. PSUSA/00000437/202209 - periodic safety update report single assessment
  421. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9…
  422. DeucravacitinibBristol-Myers Squibb
  423. European medicines regulatory network fully mobilised in fight against COVID-19
  424. cdsco-luspaterceptLuspatercept
  425. EU/3/21/2513 - orphan designation for treatment of fragile X syndrome
  426. Tibolona Aristo and Tibocina and associated names - referral
  427. European Medicines Agency investigates findings on pancreatic risks with GLP-1-based…
  428. FDA Recognizes Interoperability, Cybersecurity Standards
  429. ema-lisonorm-referralLisonorm - referral
  430. EMA reminds physicians to use Tecentriq with nab-paclitaxel for treating breast cancer
  431. EMEA-002996-PIP01-21 - paediatric investigation plan
  432. 21 CFR 866.5080: Alpha-1-antichymotrypsin immunological test system.
  433. EU/3/15/1432 - orphan designation for treatment of Huntington’s disease
  434. cdsco-alpelisibAlpelisib
  435. Clinical trials for medicines: manage your authorisation, report safety issues
  436. ema-cystadaneCystadane
  437. Somavert - withdrawal of application for variation to marketing authorisation
  438. 2023.02.08_S.O. 627(E)_Government Analyst Notification at CDTL Hyderabad
  439. 21 CFR 888.3720: Toe joint polymer constrained prosthesis.
  440. Why Not Scan 'Random' QR Codes? Cybersecurity Worries After Super Bowl LVI
  441. Medical Devices Act
  442. Aivlosin - withdrawal of application for variation to marketing authorisation
  443. PSUSA/00010465/202212 - periodic safety update report single assessment
  444. Ninth stakeholder forum on the pharmacovigilance legislation
  445. Introduction to pharmacovigilance and rules for expedited reporting of Individual Case…
  446. EU/3/20/2254 - orphan designation for treatment of inherited retinal dystrophies
  447. Meeting of all Vaccine Manufacutres & Importers on 15th January 2015
  448. 2020 European Union Good Clinical Practice Inspectors Working Group workshop
  449. ema-flolan-referralFlolan - referral
  450. Committee for Orphan Medicinal Products (COMP): 9-11 September 2025
  451. EMEA-000092-PIP02-11 - paediatric investigation plan
  452. AAMI Releases Hospital Equipment Management Standard
  453. EU/3/09/683 - orphan designation for treatment of inborn errors in primary bile acid…
  454. Clinical Trials Information System (CTIS) bitesize talk: Part I-only applications and Part…
  455. ema-atrynATryn
  456. ema-orathecinOrathecin
  457. Stem cell-based products for veterinary use: Specific question on target animal safety…
  458. cdsco-ly3502970LY3502970
  459. Workshop on access to clinical-trial data and transparency kicks off process towards…
  460. Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety…
  461. ema-how-the-committees-workHow the committees work
  462. Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting…
  463. Paediatric Committee (PDCO): 8-10 October 2014
  464. January 11, 2019: Joint Meeting of the Arthritis Advisory Committee and the Drug Safety…
  465. PSUSA/00001166/201602 - periodic safety update report single assessment
  466. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 September 2015
  467. Software for use with COVID-19 rapid antigen self-tests
  468. 21 CFR 20.120: Records available in Food and Drug Administration Public Reading Rooms.
  469. EMEA-001211-PIP01-11-M02 - paediatric investigation plan
  470. 70% Human Insulin Isophane Suspension and 30% Human Insulin Injection (100 U/mL)
  471. Sean Loughlin: Ebola and the Future of Medical Device Interoperability
  472. EMEA-002175-PIP01-17 - paediatric investigation plan
  473. Cancellation of products underRC/COS-001655, for import of Cosmetics under Cosmetics…
  474. EMEA-001147-PIP02-20 - paediatric investigation plan
  475. ema-sertindole-referralSertindole - referral
  476. Vilanterol Trifenatate eq. to Vilanterol 25mcg + Glycopyrroalte IP eq. to Glycopyrronium…
  477. Notice for dated 27.05.2016 regarding Launch of Test License Module in Sugam Portal
  478. FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can…
  479. 21 CFR 20.114: Data and information submitted pursuant to cooperative quality assurance…
  480. Demonstration of efficacy of ectoparasiticides - Scientific guideline
  481. Veterinary Medicinal Products Regulation
  482. World Diabetes Day: 14 November 2012
  483. Committee for Medicinal Products for Human Use (CHMP): 27-30 March 2023
  484. Committee for Advanced Therapies (CAT): 19-20 June 2014
  485. Rivaroxaban product-specific bioequivalence guidance
  486. ema-bekemvBekemv
  487. RO7790121/F05, 225 mg/1.5 ml (antibody) (RVT-3101, ANTI TL1A)142
  488. EMEA-000308-PIP02-11-M01 - paediatric investigation plan
  489. ema-leucogenLeucogen
  490. ema-support-for-early-accessSupport for early access
  491. ema-intunivIntuniv
  492. ema-lymphoseekLymphoseek
  493. 21 CFR 801.116: Medical devices having commonly known directions.
  494. Dydrogesterone Extended Release Tablet 20 mg
  495. EU/3/15/1471 - orphan designation for treatment of Wilson's disease
  496. 2022.08.10_S.O. 3758(E)_To authorize director incharge of CDL Kolkata for signing report…
  497. Study Finds Low-Dose CT as Effective as Standard Dose for Differentiating Appendicitis
  498. Committee for Medicinal Products for Veterinary Use (CVMP): 15-16 April 2019
  499. EMA Management Board: highlights of March 2023 meeting
  500. Control of Clinical Trials and Drugs Act 1990 [Establishment of the HPRA]
  501. EMEA-001604-PIP01-13-M03 - paediatric investigation plan
  502. cdsco-remicadeRemicade
  503. Committee for Herbal Medicinal Products (HMPC): 10-11 March 2010
  504. Market exclusivity: orphan medicines
  505. Rocket Scientists Create—and Doctors Test—Ventilator for COVID-19 Patients
  506. 21 CFR 862.1450: Lactic acid test system.
  507. European medicines agencies network strategy
  508. 2025.10.16_ G.S.R. 756(E)_ Draft Notification regarding Debarment of applicant for…
  509. ema-caprelsaCaprelsa
  510. PSUSA/00000629/201608 - periodic safety update report single assessment
  511. PSUSA/00000284/201911 - periodic safety update report single assessment
  512. cdsco-gefapixant-tabletsGefapixant tablets
  513. European Medicines Agency update on Diane 35 and generics used in the treatment of acne
  514. PSUSA/00001075/201804 - periodic safety update report single assessment
  515. 21 CFR 1.1101: What documents are incorporated by reference in this subpart
  516. Daily Updation of No.of Batches of Cough syrup sample for Export at Different Laboratories…
  517. ema-ich-considerationsICH: considerations
  518. 21 CFR 870.2370: Electrocardiograph surface electrode tester.
  519. EU/3/22/2592 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter…
  520. EMEA-002117-PIP01-17-M02 - paediatric investigation plan
  521. PSUSA/00002500/202303 - periodic safety update report single assessment
  522. EU/3/11/865 - orphan designation for treatment of retinitis pigmentosa
  523. 21 CFR 890.3850: Mechanical wheelchair.
  524. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 February 2018
  525. EMEA-002099-PIP01-16 - paediatric investigation plan
  526. Q9: Quality Risk Management - International Council for Harmonisation
  527. Drug Safety Update: monthly PDF newsletter: Drug Safety Update July 2022
  528. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 August 2012
  529. Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety…
  530. EU/3/10/792 - orphan designation for treatment of small cell lung cancer
  531. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 September 2013
  532. 21 CFR 14.120: Establishment of the Technical Electronic Product Radiation Safety…
  533. ema-avandiaAvandia
  534. 21 CFR 1.24: Exemptions from required label statements.
  535. 2017 Forum on bioequivalence inspections
  536. EU/3/21/2547 - orphan designation for treatment of primary sclerosing cholangitis
  537. cdsco-bay-3283142BAY 3283142
  538. Committee for Orphan Medicinal Products (COMP): 10-12 June 2025
  539. ema-farestonFareston
  540. cdsco-aflibercept-with-eyleaAflibercept with Eylea
  541. PSUSA/10381/201704 - periodic safety update report single assessment
  542. About Q&A on the Guidance for Preparation of Application Forms for Registration of Drug…
  543. PSUSA/00009205/201901 - periodic safety update report single assessment
  544. Rubric for Applying CVSS to Medical Devices
  545. Meeting of DTAB sub Committee for examining the 344 FDCs+05FDCs and to provide hearing to…
  546. 2024.07.10_DR_G.S.R. 375(E)_Notification for No Advertisements of Drugs Specified in…
  547. Submission of clinical trial site addition and change of principal Investigator…
  548. cdsco-teriflunomideTeriflunomide
  549. EU/3/24/2892 - orphan designation for treatment of small cell lung cancer
  550. cdsco-itolizumab-injectionItolizumab Injection
  551. EMEA-002270-PIP04-20 - paediatric investigation plan
  552. cdsco-sait101SAIT101
  553. 21 CFR 872.3750: Bracket adhesive resin and tooth conditioner.
  554. EMEA-001102-PIP01-10 - paediatric investigation plan
  555. 21 CFR 26.13: Transmission of postapproval inspection reports.
  556. PSUSA/00002210/201704 - periodic safety update report single assessment
  557. Medical Device Foreign Risk Notification
  558. 21 CFR 864.7250: Erythropoietin assay.
  559. 21 CFR 872.3275: Dental cement.
  560. cdsco-skb264-mk-2870SKB264 (MK-2870)
  561. 21 CFR 886.4770: Ophthalmic operating spectacles (loupes).
  562. 21 CFR 70.25: Labeling requirements for color additives (other than hair dyes).
  563. 21 CFR 74.2206: D&C Green No. 6.
  564. 21 CFR 864.3010: Tissue processing equipment.
  565. Decree of the Ministry of Health of the People’s Republic of China
  566. Rabies Vaccine, Human, I.P.
  567. 21 CFR 880.6230: Tongue depressor.
  568. EU/3/20/2339 - orphan designation for treatment of activated phosphoinositide 3-kinase…
  569. European Medicines Agency's 2010 accounts approved by European Parliament
  570. eXtended EudraVigilance Medicinal Product Dictionary training course - October 2021
  571. EMEA-002716-PIP01-19 - paediatric investigation plan
  572. HMA-EMA joint Big Data Steering Group
  573. In Vitro Methods Development and Validation for Generic Drugs
  574. EMEA-002569-PIP04-19 - paediatric investigation plan
  575. 'First-in-man' clinical trials guideline released for public consultation
  576. Can regulators influence the affordability of medicines?
  577. Faulty ASR Hip Implant Manufactured by M/s DePuy International Limited U.K
  578. 21 CFR 74.2052: D&C Black No. 2.
  579. European Medicines Agency closed 21 December 2018 to 2 January 2019
  580. Guidance for industry: Keyword index to assist manufacturers in verifying the class of…
  581. ema-vazkepaVazkepa
  582. 21 CFR 868.1040: Powered algesimeter.
  583. ema-nyractaNyracta
  584. PSUSA/00000575/201704 - periodic safety update report single assessment
  585. FAQs on Electronic Study Data Submission
  586. Hip Replacement Navigation Positioning System Approved for Marketing
  587. cdsco-lumateperoneapLumateperoneap
  588. Fourth industry stakeholder platform on research and development support
  589. EMEA-001645-PIP01-14-M04 - paediatric investigation plan
  590. ema-btvpur-alsap-1BTVPUR AlSap 1
  591. ema-vivjoaVivjoa
  592. JDQ443 versus docetaxel
  593. ema-nyvepriaNyvepria
  594. Toripalimab Injection, 240 mg/ 6ml
  595. Prandin - withdrawal of application for variation to marketing authorisation
  596. New add-on treatment to insulin for treatment of certain patients with type 1 diabetes
  597. Sale of In-Vitro Fertilization media, reagents and related consumables used in Assisted…
  598. AAMI Foundation Awards 2024 Scholarships to Students
  599. 21 CFR 866.3370: Mycobacterium tuberculosis immunofluorescent reagents.
  600. General Court finds no fault in 2011 appointment procedure of EMA Executive Director
  601. ema-publicationsPublications
  602. EMEA-000822-PIP01-09-M01 - paediatric investigation plan
  603. EMEA-003196-PIP01-22 - paediatric investigation plan
  604. cdsco-anti-covid-19-aks-452Anti-COVID-19 AKS-452
  605. Committee for Herbal Medicinal Products (HMPC): 5-7 May 2025
  606. What Makes a Sterilization Science Award Winner? We Interview the First
  607. Notice Ethic Committee Clinical trial
  608. Annex B Table of Content of Process Validation Documentation
  609. cdsco-ixekizumabIxekizumab
  610. ema-public-hearingsPublic hearings
  611. European Medicines Agency hosts global animal health conference on availability of…
  612. PSUSA/00000050/201805 - periodic safety update report single assessment
  613. Checklist for Form MD-8 MD
  614. Legal framework: orphan designation
  615. 21 CFR 872.6300: Rubber dam and accessories.
  616. Clynav - opinion on variation to marketing authorisation
  617. ema-sedadexSedadex
  618. iGlarLixi versus premixed
  619. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  620. PSUSA/00001826/202205 - periodic safety update report single assessment
  621. 21 CFR 866.5680: Myoglobin immunological test system.
  622. Committee for Medicinal Products for Human Use (CHMP): 17-20 January 2011
  623. ema-velmetiaVelmetia
  624. EMEA-003267-PIP02-23 - paediatric investigation plan
  625. European Medicines Agency closed 9 June 2014
  626. PSUSA-00000230-201802 - periodic safety update report single assessment
  627. Committee for Proprietary Medicinal Products (CPMP) 36th plenary meeting
  628. AMISULPRIDE 5MG/2MCT/SND/04/2024
  629. Approving clinical investigations
  630. Guidance for medicine developers and other stakeholders on COVID-19
  631. Recommendation-NB-MED-2_5_5 Rec2- Conformity assessment procedures for hip, knee and…
  632. Management Board meetings
  633. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2018
  634. ema-lopid-referralLopid - referral
  635. Further questions and answers on the follow-up to the Viracept recall
  636. 21 CFR 822.3: How do you define the terms used in this part?
  637. ema-aimovigAimovig
  638. cdsco-azacitidineAzacitidine
  639. 21 CFR 74.2151: D&C Brown No. 1.
  640. Scientific guidelines: paediatrics
  641. Guideline on clinical investigation of medicinal products indicated for the treatment of…
  642. EU/3/21/2461 - orphan designation for treatment of pantothenate kinase-associated…
  643. New medicine for rare, chronic liver disease
  644. EMA EudraVigilance information day
  645. Samantha Jacques: Clinical Engineering Has Crucial Role in Facilities Projects
  646. Basic Principles of Biological Safety Evaluation Required for Application for Approval to…
  647. European Medicines Agency invites registrations for eSubmission Gateway
  648. cdsco-perampanelPerampanel
  649. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - July 2016
  650. Meeting highlights from the Paediatric Committee: 6 - 8 May 2008
  651. DR_G.S.R. 48(E) dt_31.01.1984_10A_Prohibition of import of Methaqualone
  652. Instructions on Labeling and Management of Unique Device Identifiers
  653. Paediatric Committee (PDCO): 20-22 July 2016
  654. EU/3/09/628 - orphan designation for treatment of acute lymphoblastic leukaemia
  655. EMEA-001677-PIP01-14 - paediatric investigation plan
  656. Drug Alert list for month of August 2019
  657. Team-NB Position Paper Interimmeasures Verifclass D V1
  658. cdsco-sar445229-amlitelimabSAR445229 / amlitelimab
  659. HRF-10071, Tenofovir, Dolutegravir
  660. Terminology in pharmacogenetics - Scientific guideline
  661. Ciprofloxacin Bayer - referral
  662. Cellular, Tissue, and Gene Therapies Advisory Committee July 30, 2026 Meeting Announcement…
  663. cdsco-cetilistatCetilistat
  664. Real world research on medicines: contribution of the European Network of Centres in…
  665. NMPA Announcement on Issuing the Catalogue of Medical Devices Exempt from Clinical Trials…
  666. ema-teriflunomide-mylanTeriflunomide Mylan
  667. 21 CFR 880.5630: Nipple shield.
  668. EU/3/19/2194 - orphan designation for treatment of congenital adrenal hyperplasia
  669. 21 CFR 880.5500: AC-powered patient lift.
  670. 21 CFR 862.1565: 6-Phosphogluconate dehydrogenase test system.
  671. Additive Manufacturing Matching Knee Prosthesis Approved for Marketing
  672. Clinical investigations: compiling a submission
  673. Public Statement on the risk of drug interactions with Hypericum perforatum (St John's…
  674. Tygacil - Increased risk of death with Tygacil (tigecycline) compared to other antibiotics…
  675. Formula for grant of Compensation to the patients who were implanted with ASR Hip and…
  676. Regulations for Administration on Human Organ Bank
  677. EU/3/21/2495 - orphan designation for treatment of malignant mesothelioma
  678. 21 CFR 866.5860: Total spinal fluid immunological test system.
  679. Therapeutic goods advertising compliance: 2021-22 Annual Report
  680. Paediatric Committee (PDCO): 9-11 January 2013
  681. Background to the CPMP Position Paper on selective serotonin uptake inhibitors (SSRIs) and…
  682. PSUSA/00001989/201508 - periodic safety update report single assessment
  683. EMEA-001069-PIP01-10 - paediatric investigation plan
  684. EU/3/15/1493 - orphan designation for treatment of perinatal asphyxia
  685. Regulations for Medicament Contract Manufacture and Analysis, Regulations for Medicament…
  686. LPS Lower Extremity Dovetail IntercalaryComponent
  687. 21 CFR 866.5150: Bence-Jones proteins immunological test system.
  688. Notice regarding documents for applying as subject experts in various panels of CDSCO
  689. Lavandulae flos - herbal medicinal product
  690. Cybersecurity: HSCC’s New Legacy Device Report, & TJC Looks Ahead
  691. EU/3/16/1745 - orphan designation for treatment of diffuse large B-cell lymphoma
  692. ema-duloxetine-zentivaDuloxetine Zentiva
  693. EMEA-000322-PIP01-08-M06 - paediatric investigation plan
  694. Celebrating 20 years: EMA launches anniversary book
  695. PSUSA/00001629/201705 - periodic safety update report single assessment
  696. 21 CFR 58.51: Specimen and data storage facilities.
  697. EMEA-000019-PIP06-09-M05 - paediatric investigation plan
  698. AAMI Accepting Nominations for 2025 Awards
  699. FDA requires removal of some prescribing and dispensing restrictions for…
  700. Expert workshop on setting specifications for biotechnological products
  701. 21 CFR 60.46: Administrative decision.
  702. European Medicines Agency looks to stimulate better use of genomic data and biomarkers in…
  703. Multi-stakeholder workshop with the HMA/EMA task force on availability of authorised…
  704. ema-exaliefExalief
  705. EMEA-003355-PIP01-22 - paediatric investigation plan
  706. PSUSA/00010271/202007 - periodic safety update report single assessment
  707. How to Jump-Start a Career in Industrial Sterilization
  708. Bromocriptine-containing medicines indicated in the prevention or suppression of…
  709. EU/3/16/1697 - orphan designation for treatment of adenovirus infection in…
  710. PSUSA/00010475/201607 - periodic safety update report single assessment
  711. DR_G.S.R. 101(E) dt_13.02.2020_Definition, Responsibility & labelling requirements for…
  712. PSUSA/00002829/201511 - periodic safety update report single assessment
  713. Steam Distribution for Retort Venting in Food Canneries
  714. New Warning and Contraindication for blood pressure medicines containing aliskiren…
  715. 21 CFR 26.63: General coverage of this part.
  716. ema-omidriaOmidria
  717. 21 CFR 56.120: Lesser administrative actions.
  718. EU/3/05/298 - orphan designation for treatment of Cushing's syndrome secondary to ectopic…
  719. Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and…
  720. PSUSA/00000615/202204 - periodic safety update report single assessment
  721. Scientific Advisory Group on Neurology
  722. Committee for Orphan Medicinal Products: March 2007 Meeting
  723. ema-quadrametQuadramet
  724. Clinical Trials Information System (CTIS): Walk-in clinic - March 2022
  725. PSUSA/00002117/201811 - periodic safety update report single assessment
  726. Testing Laboratories approved by Statas & UT in Form 37 of Drugs Rule 1945 and Cos 23 of…
  727. Bylvay - opinion on variation to marketing authorisation
  728. First medicine for spinal muscular atrophy
  729. Committee for Orphan Medicinal Products (COMP): 18-20 June 2019
  730. 21 CFR 862.2485: Electrophoresis apparatus for clinical use.
  731. Third European Medicines Agency and Affordable Medicines Europe bilateral meeting
  732. Virtual live hands-on training course for clinical trials sponsors using EudraVigilance…
  733. 21 CFR 58.210: Actions upon disqualification.
  734. EMEA-003048-PIP01-21 - paediatric investigation plan
  735. Public Statement: Epoetins and the risk of tumour growth progression and thromboembolic…
  736. Management Board: Meetings 2013
  737. ema-crixivanCrixivan
  738. EMEA-000420-PIP01-10 - paediatric investigation plan
  739. ema-fulphilaFulphila
  740. Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 October…
  741. EU/3/23/2771 - orphan designation for treatment of otoferlin gene-mediated hearing loss
  742. EMEA-000316-PIP02-11-M05 - paediatric investigation plan
  743. European Medicines Agency (EMA) Human Scientific Committees' Working Parties with…
  744. Report on EFPIA infoday - 22 october 1999
  745. 21 CFR 868.5160: Gas machine for anesthesia or analgesia.
  746. EMEA-002536-PIP01-18-M03 - paediatric investigation plan
  747. EU/3/00/009 - orphan designation for treatment of erythema nodosum leprosum (ENL) or type…
  748. EU/3/12/1061 - orphan designation for treatment of idiopathic pulmonary fibrosis
  749. EU/3/18/2050 - orphan designation for treatment of neurofibromatosis type 1
  750. Teclistamab 30mg/3mL Vial (10mg/mL) and 153mg/1.7mL vial (90mg/mL) solution for injection
  751. Committee for Proprietary Medicinal Products (CPMP) 19th plenary meeting
  752. 21 CFR 876.5990: Extracorporeal shock wave lithotripter.
  753. 21 CFR 884.6165: Intravaginal culture system.
  754. ema-livensaLivensa
  755. PSUSA/00010217/201609 - periodic safety update report single assessment
  756. Ark Therapeutics withdraws its marketing authorisation application for Cerepro
  757. PSUSA/00010502/201707 - periodic safety update report single assessment
  758. Grouping application to add an export name to a registered product under section 23 of the…
  759. Twelfth meeting of the industry stakeholder platform on research and development support
  760. 21 CFR 868.1880: Pulmonary-function data calculator.
  761. Blood Products Advisory Committee May 9, 2024 Meeting Announcement - 05/09/2024
  762. 21 CFR 892.1640: Radiographic film marking system.
  763. Priyanka Upendra: Push Through Setbacks, Learn, and Move On
  764. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April…
  765. 21 CFR 1.1465: How will FDA update the Food Traceability List?
  766. EMEA-001971-PIP02-16-M04 - paediatric investigation plan
  767. EMEA-000191-PIP01-08-M05 - paediatric investigation plan
  768. Classification of a product as intended for a limited market and eligibility for…
  769. Dan Pettus: Open vs. Proprietary-Accessible vs. Proprietary-Closed
  770. EU/3/12/1024 - orphan designation for treatment of Lawrence syndrome
  771. Zinc Citrate Trihydrate eq. to Zinc IP +Ascorbic Acid IP effervescent tablets (Phase IV)
  772. EMEA-001157-PIP01-11-M02 - paediatric investigation plan
  773. ema-bortezomib-accordBortezomib Accord
  774. EMA Management Board: highlights of March 2022 meeting
  775. ema-eudragmdp-databaseEudraGMDP database
  776. Good manufacturing practices for medical gases (GUI-0031)
  777. CMS Adds to Telehealth Services Covered During COVID-19
  778. Valproate - reproductive risks
  779. European Medicines Agency and United States Food and Drug Administration seek potential…
  780. ema-fentrix-referralFentrix - referral
  781. AS F0017.1.003 Technical Review and Recognition Decision Flowchart (PDF)
  782. EMEA-002356-PIP02-20-M01 - paediatric investigation plan
  783. Consideration in the development of drugs for pulmonary arterial hypertension (Early…
  784. European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment)…
  785. Antimicrobial resistance in veterinary medicine
  786. EMA organises public meeting on COVID-19 vaccines
  787. ema-pregabalin-zentiva-k-sPregabalin Zentiva k.s.
  788. Carbon Ion Therapy System Approved for Marketing
  789. Clinical Evaluation Guidelines for Quasi-drugs
  790. EU/3/05/318 - orphan designation for prevention of tuberculosis disease in…
  791. Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety…
  792. 21 CFR 878.5050: Surgical smoke precipitator.
  793. Medical Devices Regulations (justice.gc.ca)
  794. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations…
  795. ema-memantine-accordMemantine Accord
  796. Public notice for online filing of applications for veterinary drugs
  797. European Medicines Agency publishes supplementary information on funding for medicine…
  798. PSUSA/00002849/201411 - periodic safety update report single assessment
  799. PSUSA/00010474/202207 - periodic safety update report single assessment
  800. 21 CFR 1.932: Under what circumstances may we modify or revoke a waiver?
  801. EMEA-001447-PIP02-21 - paediatric investigation plan
  802. EU/3/09/635 - orphan designation for treatment of systemic sclerosis
  803. PSUSA/00010051/202107 - periodic safety update report single assessment
  804. Vildagliptin (as sustained release form) + Metformin Hydrochloride As sustained release…
  805. P/198/2011 - paediatric investigation plan
  806. Polymethyl methacrylate
  807. Regulatory cooperation to improve global health
  808. Eucalypti folium - herbal medicinal product
  809. Members of Congress Introduce Legislation on Earlier Coverage of Breakthrough Devices
  810. PSUSA/00001040/201707 - periodic safety update report single assessment
  811. FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough…
  812. cfr-21-cfr-862-1-scope21 CFR 862.1: Scope.
  813. Advertising guidance for businesses involved with stem cells and other human cell or…
  814. 21 CFR 74.2306: D&C Red No. 6.
  815. Diclofenac-containing medicines - referral
  816. EU/3/01/080 - orphan designation for treatment of systemic sclerosis
  817. 21 CFR 868.5700: Nonpowered oxygen tent.
  818. ema-gardasilGardasil
  819. 21 CFR 882.1835: Physiological signal amplifier.
  820. Instrument for Pre-accession Assistance project 2011-2013
  821. PSUSA/00000598/201601 - periodic safety update report single assessment
  822. ema-vyndaqelVyndaqel
  823. ema-posaconazole-accordPosaconazole Accord
  824. June 8th 2017 S.O 1851(E),1852 (E), 1853 (E),1854 (E), 1855(E)
  825. Committee for Advanced Therapies (CAT): 17-19 February 2021
  826. EU/3/17/1902 - orphan designation for treatment of hepatocellular carcinoma
  827. ePI information workshop and exploratory workshop
  828. EMEA-001881-PIP01-15 - paediatric investigation plan
  829. Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June…
  830. PSUSA/00000007/202012 - periodic safety update report single assessment
  831. EMEA-001710-PIP04-17-M03 - paediatric investigation plan
  832. ema-metalyseMetalyse
  833. EMEA-002302-PIP01-17 - paediatric investigation plan
  834. EU/3/15/1555 - orphan designation for treatment of beta thalassaemia intermedia and major
  835. Tetrazepam-containing medicines - referral
  836. 21 CFR 812.47: Emergency research under § 50.24 of this chapter.
  837. EU/3/24/2947 - orphan designation for treatment of variegate porphyria
  838. EU/3/23/2860 - orphan designation for prevention of primary graft dysfunction following…
  839. ema-luminityLuminity
  840. EU/3/14/1251 - orphan designation for treatment of glycogen storage disease type II…
  841. Meeting of the EMEA working party on herbal medicinal products: 2 - 3 February 2004
  842. ema-olumiantOlumiant
  843. ema-zactimaZactima
  844. Actions concerning Applications for Marketing Approval related to the Period of…
  845. European Medicines Agency finalises first set of guidelines on good pharmacovigilance…
  846. Regulations Governing Accreditation and Outsourced Accreditation Management of Drugs…
  847. Mary Logan: We Need 'The Points Guy' for Healthcare Data
  848. EU/3/01/030 - orphan designation for treatment of cystic fibrosis
  849. Monitoring of products originating from Japan for the possibility of radioactivity
  850. 21 CFR 801.127: Medical devices; expiration of exemptions.
  851. 21 CFR 25.35: Tobacco product applications.
  852. EMEA-002399-PIP01-18-M01 - paediatric investigation plan
  853. EMEA-001885-PIP01-15-M01 - paediatric investigation plan
  854. EMEA-001050-PIP02-18-M02 - paediatric investigation plan
  855. EMEA-002329-PIP02-20-M02 - paediatric investigation plan
  856. EMEA-001706-PIP01-14-M03 - paediatric investigation plan
  857. cdsco-roxadustat-fg-4592Roxadustat (FG-4592)
  858. Workshop on the development of antimicrobial medicinal products for paediatric patients
  859. March 9, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
  860. 21 CFR 888.3790: Wrist joint metal constrained cemented prosthesis.
  861. International Women’s Day 2023: #EmbraceEquity: Richa Pathak Sharma, IT Systems…
  862. NB-MED letter to MS on 2007_47 implementation
  863. Specific efficacy requirements for ectoparasiticides in sheep - Scientific guideline
  864. 21 CFR 7.42: Recall strategy.
  865. Medical devices: UK approved bodies: BSI Assurance UK Ltd In vitro Diagnostics Medical…
  866. PSUSA/00002800/201611 - periodic safety update report single assessment
  867. EMEA-000397-PIP01-08 - paediatric investigation plan
  868. 21 CFR 880.6900: Hand-carried stretcher.
  869. HBI-8000 Combined with Nivolumab
  870. PSUSA/00003090/201801 - periodic safety update report single assessment
  871. SSRIs and SNRIs: use and safety: Selective serotonin reuptake inhibitors (SSRIs) and…
  872. COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or…
  873. Texas Health Resources Streamlines Medical Device Updating with WSUS
  874. EU/3/18/2019 - orphan designation for treatment of Alport syndrome
  875. ema-zalvisoZalviso
  876. EMEA-001017-PIP01-10-M01 - paediatric investigation plan
  877. Committee for medicinal products for veterinary use: Meeting of 15-17 January 2008
  878. ema-buflomedil-referralBuflomedil - referral
  879. Ministerial Order on the Standard of Manufacturing Control and Quality Control for…
  880. EMEA-000060-PIP01-07-M03 - paediatric investigation plan
  881. Committee for Orphan Medicinal Products (COMP): 11-13 July 2016
  882. Product Management Service (PMS) Webinar on Data Migration
  883. Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 October 2021
  884. EMEA-001631-PIP01-14-M05 - paediatric investigation plan
  885. EU/3/16/1826 - orphan designation for prevention of graft rejection following solid organ…
  886. ema-palonosetron-hospiraPalonosetron Hospira
  887. Regulations of Buildings and Facilities of Pharmacies, etc.
  888. 21 CFR 880.5145: Medical bassinet.
  889. EMEA-000775-PIP01-09-M02 - paediatric investigation plan
  890. Online training: How to submit Initial and follow-up scientific advice applications…
  891. EU/3/09/639 - orphan designation for treatment of glioma
  892. Insulin Aspart Mix (30% Insulin Aspart and 70% Insulin Aspart Protamine suspension)…
  893. EU/3/10/762 - orphan designation for treatment of chronic myeloid leukaemia
  894. Mycophenolate: updated recommendations for contraception for men and women
  895. EU/3/23/2865 - orphan designation for treatment of glioma
  896. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10…
  897. PSUSA/00002338/201706 - periodic safety update report single assessment
  898. EMEA-001137-PIP01-11 - paediatric investigation plan
  899. cdsco-secukinumabSecukinumab
  900. 21 CFR 821.25: Device tracking system and content requirements: manufacturer requirements.
  901. cdsco-darolutamideDarolutamide
  902. ema-integrilinIntegrilin
  903. European Union (Clinical Trials on Medicinal Products for Human Use) (Principal)…
  904. 21 CFR 864.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  905. EMEA-001513-PIP01-13 - paediatric investigation plan
  906. 21 CFR 25.40: Environmental assessments.
  907. EU/3/01/042 - orphan designation for prevention of scarring in glaucoma filtration…
  908. Order SAE dated 29.10.2018
  909. Veterinary Scientific Advice Workshop
  910. Daruph and Anafezyn - referral
  911. 21 CFR 74.302: Citrus Red No. 2.
  912. Committee for Orphan Medicinal Products (COMP): 10-12 November 2015
  913. Clinical Trials Information System (CTIS): Walk-in clinic - March 2024
  914. Environmental risk assessment of veterinary medicinal products intended to be used in…
  915. International regulators and WHO address need to boost COVID-19 vaccine confidence
  916. EU/3/09/702 - orphan designation for treatment of malaria
  917. News in Brief: October 2020
  918. Fluoroquinolone and quinolone antibiotics: PRAC recommends new restrictions on use…
  919. Baytril 10% oral solution - referral
  920. cdsco-drl-abDRL_AB
  921. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 12…
  922. 21 CFR 864.1870: Early growth response 1 (EGR1) gene fluorescence in-situ hybridization…
  923. Pharmacovigilance Skill Development Programme
  924. 21 CFR 864.8540: Red cell lysing reagent.
  925. Pat Lynch: The Exhibit Hall Awaits
  926. Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 April 2011
  927. PSUSA/00003159/201512 - periodic safety update report single assessment
  928. ema-lagevrioLagevrio
  929. EU/3/17/1854 - orphan designation for treatment of thromboangiitis obliterans (Buerger's…
  930. Provisions for Medical Device Registration (Abolished)
  931. High-quality data to empower data-driven medicines regulation in the European Union
  932. Committee for Medicinal Products for Human Use (CHMP): 18-21 October 2010
  933. 21 CFR 872.1730: Electrode gel for pulp testers.
  934. NMPA CDE Announcement on Issuing the Technical Guideline for Safety Information Assessment…
  935. ema-novonormNovoNorm
  936. EMEA-001568-PIP03-14 - paediatric investigation plan
  937. DR_G.S.R. 303(E) dt_30.03.2017_Shedule H_Etizolam was included
  938. European Medicines Agency EudraVigilance and signal management information day
  939. EU/3/08/532 - orphan designation for treatment of amyotrophic lateral sclerosis
  940. Increasing oversight of API manufacturing through international collaboration
  941. Team-NB Position Paper TCP V1
  942. Committee for Medicinal Products for Human Use (CHMP): 09-12 December 2024
  943. List of Drugs Medical Devices Vaccine and Cosmetics declared as Spurious for the Month of…
  944. AAMI News, September 2021, Vol.56, No.9
  945. ICH S1C (R2) Dose selection for carcinogenicity studies of pharmaceuticals - Scientific…
  946. 21 CFR 890.3860: Powered wheelchair.
  947. Drug Alert list for month of April 2023
  948. Cybersecurity Certification for Medical Device Manufacturers Sets a New Bar
  949. Perspective: FDA’s Pilot Program on Recalls Aims To Enhance Public Communications
  950. ema-enbrelEnbrel
  951. 21 CFR 888.4800: Template for clinical use.
  952. ema-lacosamide-adroiqLacosamide Adroiq
  953. 21 CFR 1.691: How do I request reconsideration of a denial by FDA of an application or a…
  954. European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 (SI 304/2001)…
  955. 21 CFR 864.6700: Erythrocyte sedimentation rate test.
  956. Cibinqo / Jyseleca / Olumiant / Rinvoq / Xeljanz - direct healthcare professional…
  957. EMEA-002064-PIP01-16-M05 - paediatric investigation plan
  958. Notice regarding transfer folicy for the officers/ Officials of CDSCO
  959. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 January 2024
  960. Recommendation-NB-MED-2_13-1_rev3 CE-Marking of pre-MDD devices
  961. F0003.2.001 MDSAP Membership Application Form
  962. 21 CFR 882.5600: Neurovascular mechanical thrombectomy device for acute ischemic stroke…
  963. 21 CFR 862.3035: Amikacin test system.
  964. ema-sorafenib-accordSorafenib Accord
  965. EMEA-003156-PIP02-22 - paediatric investigation plan
  966. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20…
  967. cdsco-evenamideEvenamide
  968. Neurochem withdraws its marketing authorisation application for Kiacta (eprodisate…
  969. Sperm and ova error or accident investigation report form (FRM-0447)
  970. EMEA-000067-PIP02-11-M02 - paediatric investigation plan
  971. EU/3/16/1792 - orphan designation for treatment of diffuse large B-cell lymphoma
  972. P/0289/2015 - paediatric investigation plan
  973. Remdesivir for injection 100mg/vial
  974. EU/3/07/508 - orphan designation for treatment of Castleman's disease
  975. 21 CFR 864.5950: Blood volume measuring device.
  976. PSUSA/00002868/201706 - periodic safety update report single assessment
  977. HRF-10071, Tenofovir alafenamide and Ripivirine
  978. EU/3/14/1260 - orphan designation for treatment of Charcot-Marie-Tooth disease type 1A
  979. Grindeliae herba - herbal medicinal product
  980. EMEA-001590-PIP01-13-M04 - paediatric investigation plan
  981. UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic…
  982. EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver…
  983. Chimpanzee Adenovirus Vectored
  984. ema-tizveniTizveni
  985. EMEA-002896-PIP01-20 - paediatric investigation plan
  986. Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders…
  987. PSUSA/00002036/201510 - periodic safety update report single assessment
  988. EU/3/19/2223 - orphan designation for treatment of congenital hyperinsulinism
  989. Standards of Service Fees for Application Review of Human Organ, Standards of Service Fees…
  990. PSUSA/00000008/202105 - periodic safety update report single assessment
  991. Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc)…
  992. EMEA-000060-PIP09-20 - paediatric investigation plan
  993. EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease
  994. Clinical Trials Information System (CTIS) webinar: Six months of CTIS and looking forward
  995. 21 CFR 814.112: Filing an HDE.
  996. Custom-made medical devices in Great Britain: Custom-made devices in Great Britain
  997. EMEA-000807-PIP01-09 - paediatric investigation plan

About this dataset

Regulations, guidance and official notices from medical device and medicines regulators worldwide, collected by Orca1 from each issuer's website. Only the title, issuer, date and link are shown here; the full text is searchable in Orca1.

Source: Medical device and medicines regulators and agencies as named on each record (EMA, MHRA, TGA, CDSCO, PMDA, NMPA, Health Canada, HSA, the FDA and others), collected by Orca1 from each issuer's website