Orca1

Data catalog

Global regulations and guidance

About 32K records

More records

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

  1. Drug Alert list for month of February 2022
  2. 21 CFR 868.5454: High flow humidified oxygen delivery device.
  3. ZS (sodium zirconium cyclosilicate
  4. EMEA-000551-PIP04-21-M02 - paediatric investigation plan
  5. PSUSA/00002316/201608 - periodic safety update report single assessment
  6. European Medicines Agency closed 1 May 2017
  7. Dapagliflozin + Metformin Hydrochloride IP + Vildagliptin film coated tablets (Phase III)
  8. Injection-site residues - Scientific guideline
  9. Wyeth Europa Ltd withdraws its marketing authorisation application forPristiqs…
  10. 21 CFR 861.38: Standards advisory committees.
  11. EMEA-001030-PIP01-10-M10 - paediatric investigation plan
  12. Consultation: Invitation to Participate in the Survey for ICH Q7 Constituencies Input for…
  13. EMA business hours over Easter holiday
  14. 21 CFR 882.1550: Nerve conduction velocity measurement device.
  15. Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 December 2023
  16. PSUSA/00001711/201607 - periodic safety update report single assessment
  17. ema-deltybaDeltyba
  18. PSUSA/00001708/202007 - periodic safety update report single assessment
  19. SoP - Compounding of Offences Rules, 2025
  20. cdsco-ly3502970eliLY3502970Eli
  21. EU/3/12/1091 - orphan designation for treatment of beta thalassaemia intermedia and major
  22. ema-extaviaExtavia
  23. Women in Leadership (WIL) Becomes Official AAMI Community
  24. Network users training for Regulatory Procedure Management 1st roll-out on IRIS
  25. ema-lotimaxLotimax
  26. Guidelines for using the TGA assessed claim on medicine labels
  27. (Appendix 12) The Standards for Marketing Approval of Nasal Drops for Rhinitis
  28. 21 CFR 884.1060: Endometrial aspirator.
  29. ema-appm-respipharm-referralAPPM Respipharm - referral
  30. cdsco-ly3502970LY3502970
  31. Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2025 (SI…
  32. ema-epclusaEpclusa
  33. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF APRIL 2024
  34. New call for patient and healthcare-professional representatives on European Medicines…
  35. ema-nobilis-ib-primo-qxNobilis IB Primo QX
  36. EU/3/16/1706 - orphan designation for treatment of carbamoyl-phosphate synthase-1…
  37. ema-vigabatrin-referralVigabatrin - referral
  38. William Hyman: Do We Know How to Evaluate and Compare Risks and Benefits?
  39. GD210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada…
  40. ema-emergency-task-force-etfEmergency Task Force (ETF)
  41. Surveillance of Drugs Manufactured in the Country by CDSCO
  42. EMEA-002353-PIP01-18 - paediatric investigation plan
  43. 21 CFR 872.3400: Karaya and sodium borate with or without acacia denture adhesive.
  44. PSUSA/00001539/202203 - periodic safety update report single assessment
  45. Risk assessment guideline focus group meeting
  46. Whole Virion, Inactivated Corona Virus Vaccine,BBV152
  47. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  48. EMEA-001705-PIP02-15-M03 - paediatric investigation plan
  49. cdsco-jdq443JDQ443
  50. EU/3/12/1034 - orphan designation for treatment of sickle cell disease
  51. EMEA-002671-PIP02-20 - paediatric investigation plan
  52. 21 CFR 73.3105: 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
  53. Recommendation-NB-MED-2_1-5_rev5 Placing on the market of fully refurbished medical…
  54. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and…
  55. PSUSA/00000126/201801 - periodic safety update report single assessment
  56. Use of herbal medicinal products containing pulegone and menthofuran - Scientific…
  57. Standards of Service Fees for Application Review of Human Organ Bank
  58. FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical…
  59. 21 CFR 882.5330: Preformed nonalterable cranioplasty plate.
  60. Connected Health and Cybersecurity: Advice about the Device
  61. DCG(I) New Year Message 2019
  62. ema-tT
  63. 21 CFR 872.1830: Cephalometer.
  64. 21 CFR 81.30: Cancellation of certificates.
  65. Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings
  66. Aesthetic-Related Guidelines_2018 [PDF, 462 KB]
  67. ema-onpattroOnpattro
  68. Top 10 for 2021: AAMI Standards Year in Review
  69. EU/3/08/533 - orphan designation for treatment of idiopathic pulmonary fibrosis
  70. ema-yondelisYondelis
  71. ema-lynparzaLynparza
  72. 21 CFR 870.1270: Intracavitary phonocatheter system.
  73. Ribavirin Mylan (previously Ribavirin Three Rivers)
  74. Antimicrobials Working Party
  75. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 September 2017
  76. ema-biological-guidelinesBiological guidelines
  77. 21 CFR 870.4260: Cardiopulmonary bypass arterial line blood filter.
  78. Nulojix - direct healthcare professional communication (DHPC)
  79. European Medicines Agency holds workshop on vaccines development against Schmallenberg…
  80. ema-effentoraEffentora
  81. 21 CFR 884.6160: Assisted reproduction labware.
  82. ema-fingolimod-mylanFingolimod Mylan
  83. Third tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches…
  84. Recombinant Human Thrombopoietin Injection
  85. PSUSA/00002067/202310 - periodic safety update report single assessment
  86. EU/3/14/1313 - orphan designation for treatment of acute myeloid leukaemia
  87. Experts Discuss Three Buzzworthy Topics During AAMI eXchange REWIRED
  88. ema-advisory-functionsAdvisory functions
  89. Points to Consider for Clinical Efficacy Evaluation of Drugs for Palmoplantar Pustulosis…
  90. Denosumab 60 mg prefilled syringe solution for injection (60 mg/mL) (r-DNA origin)
  91. Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication
  92. Webinar presentation: Personalised Medical Devices Framework
  93. ema-farydakFarydak
  94. First oral treatment for spinal muscular atrophy (SMA) recommended for approval
  95. Cox-2 selective inhibitors and non-steroidal anti-inflammatory drugs’ (NSAIDs)…
  96. 21 CFR 878.4400: Electrosurgical cutting and coagulation device and accessories.
  97. EMEA-000601-PIP01-09-M06 - paediatric investigation plan
  98. ema-factor-viii-referralFactor VIII - referral
  99. Two additional countries to benefit from EU-US mutual recognition agreement for…
  100. EU/3/18/2055 - orphan designation for treatment of glioma
  101. EU/3/09/664 - orphan designation for treatment of myelodysplastic syndromes
  102. Update on EU actions to support availability of medicines during COVID-19 pandemic
  103. ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on…
  104. PSUSA/00002160/202108 - periodic safety update report single assessment
  105. EU/3/23/2826 - orphan designation for treatment of Danon disease
  106. EU/3/14/1419 - orphan designation for treatment of Aicardi-Goutières syndrome
  107. ema-levetiracetam-tevaLevetiracetam Teva
  108. ema-onbevziOnbevzi
  109. EU/3/18/2093 - orphan designation for treatment of beta thalassaemia intermedia and major
  110. Committee for Advanced Therapies (CAT): 10-12 April 2017
  111. ema-semgleeSemglee
  112. EU/3/03/161 - orphan designation for treatment of neovascular glaucoma
  113. Cloudy with a Chance of Medtech: Forecast for Cloud-Native Medical Devices Includes…
  114. cdsco-lee011-with-lerozoleLEE011 with Lerozole
  115. From Preschooler Pianist to AAMI’s VP of Innovation and Emerging Tech, Timothy Hsu Takes…
  116. EU/3/11/918 - orphan designation for treatment of hepatocellular carcinoma
  117. AAMI News, May 2021, Vol.56, No.5
  118. Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 January 2016
  119. PSUSA/00010187/201901 - periodic safety update report single assessment
  120. 21 CFR 882.5880: Implanted spinal cord stimulator for pain relief.
  121. ema-saxendaSaxenda
  122. Essential Principles for Safety Performance of Medical Devices
  123. Presentation for Rabies Vaccine- regarding
  124. PSUSA/00001309/202204 - periodic safety update report single assessment
  125. Robert Sayle: Get Manufacturers on Board with Digital Certificates
  126. Statement from Emer Cooke on the end of the COVID-19 public health emergency
  127. PSUSA/00002310/201508 - periodic safety update report single assessment
  128. 21 CFR 890.5300: Ultrasonic diathermy.
  129. EU/3/18/2120 - orphan designation for treatment of myelodysplastic syndromes
  130. Revision of paediatric-investigation-plan guideline: stakeholder comments sought by…
  131. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28…
  132. EU/3/16/1796 - orphan designation for treatment of retinitis pigmentosa
  133. EMEA-000694-PIP05-20 - paediatric investigation plan
  134. 21 CFR 882.5235: Aversive conditioning device.
  135. Tanaka K. Current Regulation on Biosimilar in Japan. International Regulatory Science…
  136. ema-zubrinZubrin
  137. Public statement on interaction between clopidogrel and proton-pump inhibitors
  138. ema-mosquirixMosquirix
  139. Renewed Attention on Ventilators is Just the Beginning, Says Standards Developers
  140. Frontpro (previously known as Afoxolaner Merial) - opinion on variation to marketing…
  141. Guidance for the deletion of commercially confidential and personal information in an…
  142. Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the…
  143. Biologicals application form - a step-by-step guide
  144. EU/3/22/2693 - orphan designation for treatment of microvillus inclusion disease
  145. PSUSA/00009272/201509 - periodic safety update report single assessment
  146. Methodology Working Party
  147. EU/3/00/007 - orphan designation for treatment of N-acetylglutamate synthetase (NAGS)…
  148. Rules for Unique Device Identification System
  149. Committee for orphan medicines – overview of 2013 and looking ahead
  150. Prohibits to import manufacture sale and distribution and use in any food producing animal…
  151. EMEA-001261-PIP01-11-M07 - paediatric investigation plan
  152. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26…
  153. ema-prime-priority-medicinesPRIME: priority medicines
  154. ema-eravacEravac
  155. cdsco-remibrutinib-lou064remibrutinib LOU064
  156. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June…
  157. ema-latudaLatuda
  158. SSRIs and SNRIs: use and safety
  159. TGA laboratories testing report: Survey of microwavable heat packs
  160. PSUSA/00010483/202106 - periodic safety update report single assessment
  161. Clinical Trials Information System (CTIS) bitesize talk: User access and role management
  162. EU/3/21/2420 - orphan designation for treatment of PIK3CA related overgrowth spectrum
  163. Committee for Proprietary Medicinal Products (CPMP) 25th plenary meeting
  164. EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab)
  165. EMEA-001625-PIP04-22 - paediatric investigation plan
  166. Baxdrostat Tablets 1mg/ 2mg/Placebo,
  167. Guide to recall of medical devices (GUI-0054)
  168. ema-requesting-certificatesRequesting certificates
  169. Committee for Advanced Therapies (CAT): 17-19 January 2018
  170. Vi-capsular Polysaccharide-CRM197 Conjugate Typhoid Vaccine
  171. PSUSA/00010217/202209 - periodic safety update report single assessment
  172. 21 CFR 1.1365: When will FDA consider whether to adopt modified requirements or grant an…
  173. Grant of License in Form 29 under the Drugs and Cosmetics Rules 1945 dated 20/2/2020
  174. FDA’s New Digital Health Advisory Committee Will Tackle Disruptive Technologies
  175. ema-opgenraOpgenra
  176. ema-fuzeonFuzeon
  177. Avenae fructus - herbal medicinal product
  178. Human medicines: highlights of 2023
  179. cdsco-b1695502B1695502
  180. (DOC Version - 141 K)
  181. Vilanterol Trifenatate eq. to Vilanterol + Umeclidinium + Fluticasone Furoate (12.5mcg +…
  182. Committee for Medicinal Products for Human Use (CHMP): 15-18 March 2010
  183. EU/3/17/1839 - orphan designation for treatment of neuroblastoma
  184. Guidance Document: Submission of Pharmacogenomic Information
  185. Guidance Document for obtaining Free sale certificate for licensed medical Devices in…
  186. Modified live porcine respiratory and reproductive syndrome (PRRS) virus vaccines…
  187. Meeting highlights from the Paediatric Committee: 26 - 28 September 2007
  188. EMEA-003162-PIP01-21 - paediatric investigation plan
  189. cdsco-20142014
  190. PSUSA/00000143/201706 - periodic safety update report single assessment
  191. Forxiga - direct healthcare professional communication (DHPC)
  192. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate…
  193. Rabies Vaccine, Human I.P. (Purified Chick Embryo Cell Culture Rabies Vaccine) [PCECVPM]d
  194. Chapter 7 - Annual Reporting Guidance - Great Britain
  195. State NSQ Alert For The Month March-2025
  196. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  197. FDA Warns Against Use of Injectable Silicone for Body Contouring and Enhancement: FDA…
  198. PSUSA/00001642/201709 - periodic safety update report single assessment
  199. cfr-21-cfr-11-1-scope21 CFR 11.1: Scope.
  200. EU/3/18/2105 - orphan designation for treatment of pancreatic cancer
  201. EU/3/23/2853 - orphan designation for treatment of medium-chain acyl-coenzyme A…
  202. PSUSA/00001694/201803 - periodic safety update report single assessment
  203. EU/3/22/2725 - orphan designation for diagnosis of ATTR amyloidosis
  204. PSUSA/00010289/202202 - periodic safety update report single assessment
  205. EMEA-001612-PIP01-14 - paediatric investigation plan
  206. ema-keytrudaKeytruda
  207. Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration…
  208. Intramuscular Injection of Paracetamol 500 mg/2ml
  209. ema-eudravigilance-gatewayEudraVigilance Gateway
  210. EU/3/17/1923 - orphan designation for treatment of acute myeloid leukaemia
  211. PSUSA/00001309/201904 - periodic safety update report single assessment
  212. Constitution of Medical Devices Technical advisory group (MDTAG) to advise CDSCO on matter…
  213. Committee for Advanced Therapies (CAT): 10-11 March 2011
  214. Mary Logan: Warning, Warning! Systems Overload
  215. 2026.06.22 S.O. 3286(E)_Implementation of provisions under Jan Vishwas (Amendment of…
  216. European Medicines Agency closed 31 October 2014
  217. Regulatory changes for software based medical devices
  218. EMA recommends measures to ensure safe use of Keppra oral solution
  219. PSUSA/00010525/202004 - periodic safety update report single assessment
  220. EMEA-000980-PIP04-18 - paediatric investigation plan
  221. PSUSA/00002929/201603 - periodic safety update report single assessment
  222. PSUSA/00000415/201908 - periodic safety update report single assessment
  223. Guidance for pharmaceutical companies to prepare for UK's withdrawal from EU
  224. Committee for medicinal products for veterinary use: Meeting of 13 - 15 March 2007
  225. cdsco-olasertibolasertib
  226. EMEA-003045-PIP01-21 - paediatric investigation plan
  227. Visudyne - direct healthcare professional communication (DHPC)
  228. Virtual live hands-on training course for clinical trials sponsors using EudraVigilance…
  229. Budesonide IP 200mcg + Glycopyrronium (as Glycopyrrolate IP) 12.5mcg + Formoterol Fumarate…
  230. EMEA-002511-PIP02-19 - paediatric investigation plan
  231. Committee for Medicinal Products for Human Use (CHMP): 10-13 December 2012
  232. EU/3/08/579 - orphan designation for corneal lesions, with associated corneal (limbal)…
  233. PSUSA/00010298/202003 - periodic safety update report single assessment
  234. FDA Drug Safety Communication: New risk management plan and patient Medication Guide for…
  235. EMEA-001409-PIP01-12 - paediatric investigation plan
  236. ema-versican-plus-dhppi-l4Versican Plus DHPPi/L4
  237. EMEA-003051-PIP01-21 - paediatric investigation plan
  238. Telemedicine’s ‘Mess in The Middle’: A Look at Connection of RPM Devices to Providers
  239. eXtended EudraVigilance Medicinal Product Dictionary training course
  240. Maximum in-use shelf-life for medicated drinking water - Scientific guideline
  241. EU/3/15/1559 - orphan designation for treatment of systemic sclerosis
  242. FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses…
  243. Avibactam 0.5 g + Aztreonam 1.5 g Powder for Concentrate for Solution for Infusion
  244. EMEA-001136-PIP01-11-M02 - paediatric investigation plan
  245. Hydroxyethyl starch solutions for infusion - referral
  246. EU/3/01/069 - orphan designation for treatment of ileal pouch anal anastomosis (IPAA)…
  247. EMEA-001939-PIP03-16 - paediatric investigation plan
  248. ema-procoralanProcoralan
  249. PSUSA/00010243/201605 - periodic safety update report single assessment
  250. EMEA-002581-PIP01-19 - paediatric investigation plan
  251. PSUSA/00010376/201904 - periodic safety update report single assessment
  252. 21 CFR 25.41: Findings of no significant impact.
  253. Dydrogesterone Modified Release Tablet 20mg
  254. cdsco-recombinant-human-fshRecombinant human FSH
  255. Committee for Medicinal Products for Human Use (CHMP): 22-25 July 2013
  256. EU/3/16/1723 - orphan designation for treatment of alkaptonuria
  257. Transfers of conformity assessment certificates
  258. cfr-21-cfr-872-3220-facebow21 CFR 872.3220: Facebow.
  259. PSUSA/00002816/202312 - periodic safety update report single assessment
  260. Union Product Database – Volume of sales webinar for UPD industry users
  261. VICH GL44 Target animal safety for veterinary live and inactivated vaccines - Scientific…
  262. Regulatory update - EMA encourages companies to submit type I variations for 2021 in…
  263. 21 CFR 888.1520: Nonpowered goniometer.
  264. PSUSA/00002354/202010 - periodic safety update report single assessment
  265. Drug Alert list for month of Feb 2022 (Revised)
  266. Guideline on excipients in the dossier for application for marketing authorisation of a…
  267. cfr-21-cfr-17-37-witnesses21 CFR 17.37: Witnesses.
  268. EU/3/23/2760 - orphan designation for treatment of recessive X-linked ichthyosis
  269. 21 CFR 868.1120: Indwelling blood oxyhemoglobin concentration analyzer.
  270. EMEA-001715-PIP01-14-M04 - paediatric investigation plan
  271. List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for the Month…
  272. Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for…
  273. 21 CFR 866.3372: Nucleic acid-based in vitro diagnostic devices for the detection of…
  274. EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab)
  275. News in Brief: December 2019
  276. cfr-21-cfr-890-3075-cane21 CFR 890.3075: Cane.
  277. Team-NB PositionPaper-AI Designation-V1-20221216
  278. EMEA-001603-PIP01-13-M01 - paediatric investigation plan
  279. Multi-stakeholder paediatric oncology strategy workshop (cancers with anaplastic lymphoma…
  280. ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms…
  281. 21 CFR 10.203: Definitions.
  282. cdsco-bay-3401016BAY 3401016
  283. Committee for Medicinal Products for Human Use (CHMP): 15-18 November 2010
  284. 21 CFR 866.5250: Complement C1 inhibitor (inactivator) immunological test system.
  285. Workshop on clinical-trial data and transparency
  286. Pharmacogenomic samples, testing and data handling - Scientific guideline
  287. Points to consider in the clinical development of drugs for transthyretin amyloid…
  288. PSUSA/00000495/202101 - periodic safety update report single assessment
  289. Committee for Advanced Therapies (CAT): 14-15 June 2012
  290. PSUSA/00010582/202209 - periodic safety update report single assessment
  291. Pharmacovigilance: research and development
  292. Committee for Advanced Therapies (CAT): 9-11 September 2026
  293. Exceptional release of biologicals (post-market)
  294. 21 CFR 82.1205: D&C Green No. 5.
  295. ema-selincroSelincro
  296. Meeting of the EMEA working party on herbal medicinal products 11 and 12 March 2002
  297. 21 CFR 73.3121: Poly(hydroxyethyl methacrylate)-dye copolymers.
  298. 21 CFR 886.1690: Pupillograph.
  299. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
  300. 21 CFR 862.1520: 5′-Nucleotidase test system.
  301. EMEA-003107-PIP01-21 - paediatric investigation plan
  302. Office Memorandum: Avoiding multiple inspections of a facility using Risk Based Approach
  303. EMEA-002849-PIP01-20 - paediatric investigation plan
  304. Particulate Guidance Update Drives New Risk Discussions
  305. June 18.06.2013 G.S.R 378(E)
  306. Recommendation-NB-MED-2_5_1-4_rev4 Content of mandatory certificates
  307. EMEA-000639-PIP04-19 - paediatric investigation plan
  308. EMEA-002575-PIP03-21 - paediatric investigation plan
  309. Mandatory Problem Reporting for Medical Devices
  310. ema-dimethyl-fumarate-tevaDimethyl fumarate Teva
  311. 21 CFR 830.310: Information required for unique device identification.
  312. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 January 2015
  313. Training on electronic reporting of individual case safety reports (ICSRs) to…
  314. EU/3/21/2397 - orphan designation for treatment of uveal melanoma
  315. Points to consider for externally controlled trials (Early Consideration)
  316. New Cybersecurity Standards and the Rise of the “Process Standard”
  317. cfr-21-cfr-26-32-scope21 CFR 26.32: Scope.
  318. ema-vprivVpriv
  319. EU/3/18/2054 - orphan designation for treatment of Duchenne muscular dystrophy
  320. cfr-21-cfr-814-80-general21 CFR 814.80: General.
  321. Maximum shelf-life for sterile medicinal products after first opening or following…
  322. Consideration of Directions of Hon'ble Supreme Court of India in the case of 294 FDCs in…
  323. 21 CFR 862.1150: Calibrator.
  324. Paediatric Committee (PDCO): 5-7 December 2012
  325. Citri bergamiae aetheroleum - herbal medicinal product
  326. ICH Q4B Annex 10 Polyacrylamide gel electrophoresis - Scientific guideline
  327. Stroboscope
  328. 21 CFR 70.45: Allocation of color additives.
  329. ema-kolbamKolbam
  330. 21 CFR 870.3605: Pacing system analyzer.
  331. Bondenza (previously Ibandronic Acid Roche)
  332. PSUSA/00010487/201808 - periodic safety update report single assessment
  333. Arti-Cell Forte / RenuTend - direct healthcare professional communication (DHPC)
  334. cdsco-canakinumabCanakinumab
  335. Allergen products development for immunotherapy and allergy diagnosis in moderate to…
  336. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 April…
  337. 21 CFR 74.1102: FD&C Blue No. 2.
  338. Australian Dental Sector Working Group, Meeting statement, Meeting 4, 31 March 2022
  339. Notice Track and Trace for Pharmaceutical Drug consignment
  340. ema-dificlirDificlir
  341. 21 CFR 872.4465: Gas-powered jet injector.
  342. ema-terfenadine-referralTerfenadine - referral
  343. cdsco-benralizumabBenralizumab
  344. Partial Revision of New “Standard Forms for requesting clinical trials, etc.”
  345. Chemistry of active substances (chemistry of new active substances) - Scientific guideline
  346. EMEA-001729-PIP01-14-M01 - paediatric investigation plan
  347. EU/3/07/441 - orphan designation for treatment of adrenal insufficiency
  348. Salviae officinalis folium - herbal medicinal product
  349. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 October 2015
  350. Committee for Advanced Therapies (CAT) meeting with interested parties
  351. Archive of development of good pharmacovigilance practices
  352. Evaluation of Production Cleaning Processes for Electronic Medical Devices - Part III…
  353. FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and…
  354. Notice regarding Clarification for utilization of same fees in case of inadvertent…
  355. cdsco-cp-690-550CP-690,550
  356. European Medicines Agency closed 22 December 2017 to 2 January 2018
  357. 21 CFR 868.5430: Gas-scavenging apparatus.
  358. cfr-21-cfr-26-16-suspension21 CFR 26.16: Suspension.
  359. 21 CFR 807.90: Format of a premarket notification submission.
  360. EMA publishes its work programme for 2014
  361. EMEA-001348-PIP01-12-M01 - paediatric investigation plan
  362. PSUSA/00010827/202205 - periodic safety update report single assessment
  363. 21 CFR 888.4580: Sonic surgical instrument and accessories/attachments.
  364. 21 CFR 886.1760: Ophthalmic refractometer.
  365. Addressing the Total Product Lifecycle: Sustainability, Supply Chain, and Resilience
  366. EMEA-001979-PIP01-16 - paediatric investigation plan
  367. Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation…
  368. Office Memorandum Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in…
  369. EU/3/11/902 - orphan designation for treatment of neuroblastoma
  370. Supply unlicensed medicinal products (specials): The supply of unlicensed cannabis-based…
  371. Information day on risk management planning and post-authorisation studies
  372. Paediatric Oncology Strategy Forum: 24-25 October 2024
  373. Team-NB List PositionPapers 20230821
  374. Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in…
  375. EU/3/12/1069 - orphan designation for treatment of retinitis pigmentosa
  376. 21 CFR 1.1141: What is the effect on a LAAF-accredited laboratory if its recognized…
  377. cdsco-bcd-022BCD-022
  378. Cagrilintide+Semaglutide
  379. EU/3/15/1557 - orphan designation for treatment of tuberous sclerosis
  380. TEAM-NB Position in Response to MDCG 2022-14 Item Number 17 - ‘Certificates under…
  381. 21 CFR 890.3760: Powered table.
  382. EMEA-001215-PIP01-11-M07 - paediatric investigation plan
  383. Appendix 7A Guidance on Electronic Labelling for Therapeutic Products
  384. PSUSA/00000439/201711 - periodic safety update report single assessment
  385. PSUSA/00000779/201612 - periodic safety update report single assessment
  386. PSUSA/00010364/201803 - periodic safety update report single assessment
  387. EU/3/23/2824 - orphan designation for treatment of arrhythmogenic right ventricular…
  388. Committee for Orphan Medicinal Products (COMP): 10-11 April 2017
  389. Studies show increased risk of heart rhythm problems with seizure and mental health…
  390. cdsco-mesenchymal-stem-cellMesenchymal Stem Cell
  391. PSUSA/00000617/202001 - periodic safety update report single assessment
  392. EMEA-002573-PIP01-19 - paediatric investigation plan
  393. 21 CFR 73.50: Ultramarine blue.
  394. New antibiotic to fight infections caused by multidrug-resistant bacteria
  395. EU/3/22/2728 - orphan designation for treatment of amyotrophic lateral sclerosis
  396. 21 CFR 884.2800: Computerized Labor Monitoring System.
  397. PSUSA/00009225/201506 - periodic safety update report single assessment
  398. EU/3/12/967 - orphan designation for treatment of pulmonary arterial hypertension
  399. ema-ich-qualityICH: quality
  400. PAC Cancellation letter dated 12.03.2025 FSN brands Marketing Pvt Ltd
  401. 21 CFR 880.6860: Ethylene oxide gas sterilizer.
  402. SAR442168(Multiple Sclerosis)
  403. Haldol and associated names - referral
  404. Committee for Orphan Medicinal Products (COMP): 10-11 July 2012
  405. EudraVigilance training on electronic reporting of individual case safety reports in the…
  406. Diperoxochloric acid topical solution 0.29mg/mlCT/SND/12/2023
  407. EMEA-003252-PIP01-22 - paediatric investigation plan
  408. 21 CFR 17.34: Determining the amount of penalties and assessments.
  409. EMEA-003037-PIP01-21 - paediatric investigation plan
  410. 21 CFR 882.4535: Nonpowered neurosurgical instrument.
  411. Agomelatine product-specific bioequivalence guidance
  412. COVID-19 vaccines approved in the country as on 29.11.2023
  413. PSUSA/00001084/202205 - periodic safety update report single assessment
  414. 21 CFR 862.1650: Pyruvate kinase test system.
  415. Ad-hoc meeting of the Executive Steering Group on Shortages and Safety of Medicinal…
  416. Guideline on clinical investigation of medicinal products in the treatment or prevention…
  417. EMEA-000054-PIP01-07-M04 - paediatric investigation plan
  418. EMEA-002146-PIP01-17-M04 - paediatric investigation plan
  419. New Members Appointed to AAMI Foundation Board
  420. Kilmer Innovations in Packaging Group Calls for Members/Next Steps
  421. AAMI Foundation Awards 2020 Research Grants
  422. Access Generic Medicines Work Sharing Initiative
  423. EU/3/14/1308 - orphan designation for treatment of autosomal dominant polycystic liver…
  424. cfr-21-cfr-801-3-definitions21 CFR 801.3: Definitions.
  425. Mavacamten Capsules 2.5 mg, 5 mg, 10 mg and 15 mg
  426. Committee for Herbal Medicinal Products (HMPC): 29-31 January 2024
  427. Introducing Timothy Hsu, AAMI VP of Industry and Emerging Technologies
  428. EU/3/17/1844 - orphan designation for treatment of amyotrophic lateral sclerosis
  429. ema-apremilast-accordApremilast Accord
  430. EMEA-002944-PIP01-20 - paediatric investigation plan
  431. cdsco-ruxolitinibRuxolitinib
  432. Order regarding creation of 'Ayush' vertical in CDSCO
  433. Dissolution specification for generic oral immediate release products - Scientific…
  434. Twelve New Drug Advisory Committees (NDAC) ( 27 Jul 2012 )
  435. Guideline on clinical investigation of medicinal products indicated for the treatment of…
  436. Lojuxta - direct healthcare professional communication (DHPC)
  437. nbcg-team-nb-nb-med-reportTeam-NB NB-Med Report
  438. Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs…
  439. EMEA-002326-PIP04-20 - paediatric investigation plan
  440. EU/3/15/1495 - orphan designation for treatment of glucose transporter type-1 deficiency…
  441. DARWIN EU Advisory Board meeting: 20 April 2022
  442. EMEA-001525-PIP02-21 - paediatric investigation plan
  443. EU/3/23/2854 - orphan designation for treatment of ovarian cancer
  444. 2025.08.27_G.S.R. 588(E)_Draft Notification about changes to requirements of Test license…
  445. European Medicines Agency organising workshop on biosimilars
  446. Guidance for requesting reconsideration of an initial decision
  447. European Medicines Agency confirms positive benefit-risk balance of orlistat-containing…
  448. Clinical development of fixed combination medicinal products - Scientific guideline
  449. EMEA-003250-PIP01-22 - paediatric investigation plan
  450. European Medicines Agency closed 14-15 May 2015
  451. EMEA-000464-PIP01-08 - paediatric investigation plan
  452. Spikevax (previously COVID-19 Vaccine Moderna)
  453. ASEAN Guideline for Validation of Analytical Procedures
  454. 21 CFR 878.4360: Scalp cooling system to reduce the likelihood of chemotherapy-induced…
  455. 21 CFR 862.1300: Follicle-stimulating hormone test system.
  456. European Medicines Agency meetings to be held offsite during 2012 Olympics
  457. UPDATED: September 11-12, 2023: Meeting of the Nonprescription Drugs Advisory Committee…
  458. Development of vaccinia virus-based vaccines against smallpox - Scientific guideline
  459. PSUSA/00010622/202301 - periodic safety update report single assessment
  460. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7…
  461. TGA Laboratories testing of ranitidine medicines
  462. 21 CFR 872.3710: Base metal alloy.
  463. EMA and FDA encourage use of innovative approaches in the development of medicines for…
  464. CHMP working parties reorganised
  465. EU/3/14/1363 - orphan designation for treatment of cystic fibrosis
  466. Organisation Management System (OMS) Trouble Shooting Session for CTIS users - October…
  467. cdsco-itraconazoleItraconazole
  468. Suspension of fenspiride medicines due to potential risk of heart rhythm problems
  469. Committee for Herbal Medicinal Products (HMPC): 1-2 February 2016
  470. ema-yondelis-referralYondelis - referral
  471. New restrictions to minimise the risks of effects on heart rhythm with…
  472. ICH guideline S11 on nonclinical safety testing in support of development of paediatric…
  473. 21 CFR 20.47: Situations in which confidentiality is uncertain.
  474. 21 CFR 806.40: Public availability of reports.
  475. FDA Drug Safety Communication: FDA warns about case of rare brain infection PML with MS…
  476. Practical guidance on implementation of pharmacovigilance legislation published
  477. Clinical Trials Information System (CTIS): Walk-in clinic - July 2023
  478. EMEA-000516-PIP01-08 - paediatric investigation plan
  479. PSUSA/00003140/201907 - periodic safety update report single assessment
  480. Thymi aetheroleum - herbal medicinal product
  481. ema-janactiJanacti
  482. Budesonide++Glycopyrronium+ Formoterol fumarate (BGF)
  483. Study: Physical Therapy App Rivals In-Person Exercise Corrections
  484. EMEA-000915-PIP01-10 - paediatric investigation plan
  485. cdsco-crn04894decCRN04894dec
  486. EU/3/18/2065 - orphan designation for treatment of anthrax
  487. Committee for Herbal Medicinal Products (HMPC): 2-4 March 2026
  488. Tropicamide IP + Phenylephrine Hydrochloride IP + Lidocaine Hydrochloride IP per ml…
  489. ema-valproate-referralValproate - referral
  490. Omega-3 fatty acid ethyl esters - direct healthcare professional communication (DHPC)
  491. Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 January 2016
  492. Notice Order regarding draft classification of Medical Devices and IVDs
  493. Workshop on support for orphan medicines development
  494. EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring…
  495. PSUSA/00001629/202005 - periodic safety update report single assessment
  496. Foreign Pharmaceutical Manufacturers (5/96)
  497. EU/3/03/157 - orphan designation for treatment of cystic fibrosis
  498. Appendix 17 Guideline on PRISM Submission
  499. ACMD meeting statement, Meeting 36, 20 October 2017
  500. Quarterly system demo - Q2 2022
  501. GN-16-R3 Guidance on Essential Principles for Safety and Performance of Medical Devices…
  502. ema-legal-frameworkLegal framework
  503. 21 CFR 868.5460: Therapeutic humidifier for home use.
  504. 21 CFR 886.5305: Electromechanical tear stimulator.
  505. Recommendation-NB-MED-2_1-3_rev2 Accessories and other parts for Active Implantable…
  506. Risk of antimicrobial resistance transfer from companion animals - Scientific guideline
  507. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June…
  508. ema-yorvipathYorvipath
  509. FDA Drug Safety Communication: Serious liver disorder associated with the use of…
  510. EU/3/04/237 - orphan designation for treatment of Rabson-Mendenhall syndrome
  511. 21 CFR 876.4650: Water jet renal stone dislodger system.
  512. ema-pemetrexed-medacPemetrexed medac
  513. Melissa Kozak: Advancing Value-Based Care with AI and the Internet of Things
  514. ema-pyzchivaPyzchiva
  515. EMEA-002487-PIP01-18 - paediatric investigation plan
  516. Industry associations webinar: update on the implementation of European Medicines Agency…
  517. EMEA-003018-PIP01-21 - paediatric investigation plan
  518. Guideline on registry-based studies - Scientific guideline
  519. Guidance on the Licensing, GMP Certification and Inspection of Therapeutic Products…
  520. Pharmacovigilance procedures for veterinary medicines
  521. 21 CFR 820.160: Distribution.
  522. Letter to Stakeholders - Responsibilities and Obligations with Respect with the Good…
  523. ema-excipients-labellingExcipients labelling
  524. Second China domestic ECMO products approved for marketing
  525. Protelos and Osseor - referral
  526. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JAN-2018
  527. 21 CFR 7.85: Conduct of a presentation of views before report of criminal violation.
  528. cdsco-lasmiditanLasmiditan
  529. EU/3/18/1982 - orphan designation for treatment of pulmonary arterial hypertension
  530. Committee for Proprietary Medicinal Products (CPMP) 41st plenary meeting
  531. New information regarding QT prolongation with ondansetron (Zofran)
  532. EMEA-001857-PIP02-20 - paediatric investigation plan
  533. EU/3/22/2698 - orphan designation for treatment of otoferlin gene-mediated hearing loss
  534. PSUSA/00010300/201508 - periodic safety update report single assessment
  535. EMA workshop with European Union pharmaceutical industry associations on the…
  536. EU/3/11/851 - orphan designation for treatment of pancreatic cancer
  537. 21 CFR 1.500: What definitions apply to this subpart?
  538. ema-seglurometSegluromet
  539. June 07.06.2013 G.S.R 364 (E)
  540. Quofenix / Quinsair - direct healthcare professional communication (DHPC)
  541. EMEA-001945-PIP01-16-M03 - paediatric investigation plan
  542. EMEA-000726-PIP01-09-M02 - paediatric investigation plan
  543. Echinaceae pallidae radix - herbal medicinal product
  544. Radio Frequency Renal Ablation Device and Disposable Reticular Renal Denervation RF…
  545. 21 CFR 73.3107: Carbazole violet.
  546. cdsco-tislelizumabTislelizumab
  547. Partial Revision of “Points to Consider for Approval Applications for Drugs”
  548. mhra-import-a-human-medicineImport a human medicine
  549. EU/3/16/1612 - orphan designation for treatment of pantothenate-kinase-associated…
  550. SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine [COVOVAX]
  551. NOTICE regading suggestions/comments of the stakeholders including manufacturers/marketers…
  552. FDA Updates Final Guidance for Breakthrough Devices Program
  553. ema-slenytoSlenyto
  554. EU/3/21/2527 - orphan designation for treatment of cystic fibrosis
  555. EU/3/17/1861 - orphan designation for treatment of pulmonary arterial hypertension
  556. EMEA-000455-PIP02-10-M09 - paediatric investigation plan
  557. NNC 0365-3769 (Mim8) prophylaxis
  558. Big Changes Coming to CDRH Office of Product Evaluation and Quality
  559. Training session for patients and consumers interested in European Medicines Agency…
  560. AU P0019.004 Medical Device Regulatory Audit Reports Policy
  561. UPDATE: Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK…
  562. ema-xefo-referralXefo - referral
  563. Paediatric Committee (PDCO): 15-17 April 2015
  564. EMEA-002456-PIP01-18 - paediatric investigation plan
  565. ema-zoledronic-acid-mylanZoledronic acid Mylan
  566. Notice-dated 29.10.12: CDSCO Sr. Officers Meeting.
  567. PSUSA/00000748/202206 - periodic safety update report single assessment
  568. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF FEB-2018
  569. Actual and potential harm caused by medical software
  570. ema-viekiraxViekirax
  571. ema-hefiyaHefiya
  572. PSUSA/00002094/202105 - periodic safety update report single assessment
  573. European Medicines Agency launches EudraGMP – the Community GMP database
  574. EU/3/06/355 - orphan designation for treatment of acute myeloid leukaemia
  575. Chantix (varenicline) - Safety review update of Chantix (varenicline) and risk of…
  576. 21 CFR 868.5770: Tracheal tube fixation device.
  577. cfr-21-cfr-7-12-guaranty21 CFR 7.12: Guaranty.
  578. EMEA-000908-PIP01-10 - paediatric investigation plan
  579. AAMI News, September 2020, Vol.55, No.9
  580. FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines…
  581. ema-trovanTrovan
  582. ema-comtanComtan
  583. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 4-6 October…
  584. European Medicines Agency and European Commission start reflection process on way forward…
  585. ema-spor-iso-idmp-task-forceSPOR (ISO IDMP) Task Force
  586. Meeting Notice regarding Meeting with stakeholders for discussion on Zero Draft of new…
  587. ema-divence-pentaDivence Penta
  588. Regulations amending certain regulations concerning drugs and medical devices (shortages)…
  589. Gavreto - direct healthcare professional communication (DHPC)
  590. Sixth EMA-Medicines for Europe bilateral meeting
  591. 21 CFR 26.9: Equivalence determination.
  592. cdsco-lib003-with-evolocumabLIB003 with Evolocumab
  593. Pharmacovigilance inspection procedures: human
  594. Qutenza - withdrawal of application for variation to marketing authorisation
  595. EU/3/13/1197 - orphan designation for treatment of glioma
  596. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 April 2012
  597. 21 CFR 864.3400: Device for sealing microsections.
  598. EU/3/10/755 - orphan designation for prevention of late-onset sepsis in premature infants…
  599. Vonoprazan 20 Mg Tablets/ Pantoprazole 40 Mg
  600. Details of rejected applications of Human Vaccine Manufacturers or Importers (Form…
  601. cdsco-cocculus-hirsutusCocculus hirsutus
  602. IAHCSMM to Change Its Name
  603. ema-tekturnaTekturna
  604. Committee for Herbal Medicinal Products (HMPC): 13-15 March 2023
  605. cdsco-tqj230TQJ230
  606. 21 CFR 888.3400: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
  607. Guide to Refusals and Appeals
  608. ema-fycompaFycompa
  609. Medical Devices (Amendment) Regulations 2021 (SI 510/2021) [General]
  610. PSUSA/00010072/201909 - periodic safety update report single assessment
  611. EMEA-003105-PIP01-21 - paediatric investigation plan
  612. European Medicines Agency opens SME Office to support small and medium-sized enterprises
  613. European Medicines Agency starts safety review of Diane 35 and its generics
  614. PSUSA/00002105/202102 - periodic safety update report single assessment
  615. Brexpiprazole Tablets 0.25mg, 0.5mg, 1 mg, 2 mg, 3 mg and 4 mg
  616. EU/3/07/514 - orphan designation for treatment of Gaucher disease
  617. Second bilateral meeting between European Medicines Agency and Vaccines Europe
  618. EU/3/11/921 - orphan designation for treatment of glycogen storage disease type II…
  619. FDA revises description of mental health side effects of the stop-smoking medicines…
  620. 21 CFR 872.3: Effective dates of requirement for premarket approval.
  621. Advancing regulatory science in the EU – new strategy adopted
  622. EU and Swiss regulators sign confidentiality arrangement
  623. Stolen vials of medicine in Italy
  624. Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 September 2021
  625. PSUSA/00001084/201705 - periodic safety update report single assessment
  626. Partial Revision of “Partial Revision of the “Points to Consider for Approval Applications…
  627. cdsco-fluticasone-propionatefluticasone propionate
  628. ema-mysimba-referralMysimba - referral
  629. EU/3/06/407 - orphan designation for prevention of necrotising enterocolitis
  630. 21 CFR 876.5210: Enema kit.
  631. Medical Device Shortages Single Point of Contact (SPOC) Working Party
  632. A New Code of Conduct for Standards Development
  633. Launching of registration of Clinical Research Organisation applications through SUGAM…
  634. European Medicines Agency awards first 'ENCePP study' seal for post-marketing study
  635. 21 CFR 882.4150: Scalp clip.
  636. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15…
  637. ema-tidhescoTidhesco
  638. Clinical trials for medicines: Clinical Trials Regulations transitional arrangements
  639. Treatment of premenstrual dysphoric disorder - Scientific guideline
  640. Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety…
  641. EMEA-001722-PIP01-14-M02 - paediatric investigation plan
  642. Paediatric Committee (PDCO): 11-13 January 2012
  643. EMEA-001747-PIP01-15 - paediatric investigation plan
  644. Inspection Strategy for Good Pharmacovigilance Practices for Drugs (POL-0041)
  645. Patient Guide for Reporting Side Effects
  646. 21 CFR 898.13: Compliance dates.
  647. ema-hopveusHopveus
  648. remibrutinib versus teriflunomide
  649. The Shared Responsibility of Managing Cybersecurity of Medical Devices as They Age in the…
  650. EU/3/03/165 - orphan designation for treatment of hepatocellular carcinoma
  651. PSUSA/00001990/202002 - periodic safety update report single assessment
  652. Site Master File (SMF) for Plasma Warehouses
  653. EMEA-001381-PIP01-12 - paediatric investigation plan
  654. POSTPONED: January 22, 2016 Meeting of the Peripheral and Central Nervous System Drugs…
  655. EU/3/20/2360 - orphan designation for treatment of carnitine palmitoyltransferase I…
  656. Cryoablation Equipment and Balloon Cryoablation Catheter Approved for Marketing
  657. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 December 2022
  658. PSUSA/00010161/201411 - periodic safety update report single assessment
  659. Appendix 14 Guidance on MIV Applications for Biological Therapeutic Products
  660. cdsco-durvalumab-monotherapyDurvalumab Monotherapy
  661. ema-xeleviaXelevia
  662. West Nile virus and plasma-derived medicinal products - Scientific guideline
  663. European Medicines Agency information day on services and systems in pharmacovigilance…
  664. Dulaglutide solution for injection 0.75mg and 1.5mg prefilled pen
  665. Pregabalin IP + Methylcobalamin IP + Duloxetine Hydrobromide IP eq. to Duloxetine (as…
  666. EMEA-003024-PIP01-21 - paediatric investigation plan
  667. HRF-10071, Tenofovir alafenamide and Emtricitabin
  668. Six-month countdown to go-live for the Clinical Trials Information System (CTIS)
  669. EMA advises about risks of using weight loss medicine Mysimba with opioids
  670. P/17/2011 - paediatric investigation plan
  671. NovoSeven - withdrawal of application for variation to marketing authorisation
  672. New treatment for breast cancer
  673. EMEA-002131-PIP01-17 - paediatric investigation plan
  674. ema-circomax-mycoCircoMax Myco
  675. EMEA-000461-PIP02-11-M05 - paediatric investigation plan
  676. Voluntary Recall of Digene Gel manufactured by M/s Abbott India Limited, L-18/19, Verna…
  677. cdsco-blu-5937iqviaBLU-5937IQVIA
  678. Guideline on clinical investigation of medicinal products for the treatment of obsessive…
  679. New Executive Order on AI Heralds Big Changes for Medtech Space
  680. ema-solumarvSolumarv
  681. ruxolitinib and panobinostat (LBH589)
  682. PSUSA/00000312/202204 - periodic safety update report single assessment
  683. ema-dexrazoxane-referralDexrazoxane - referral
  684. Ribis nigri folium - herbal medicinal product
  685. 21 CFR 1.1151: What requirements apply to the methods of analysis a LAAF-accredited…
  686. Clinical Trials Information System (CTIS): Walk-in clinic on transitioning trials…
  687. EU/3/05/348 - orphan designation for prevention of Japanese encephalitis
  688. European Medicines Agency recommends restricting the use of dexrazoxane-containing…
  689. 21 CFR 888.3180: Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
  690. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 September 2020
  691. EMEA-000571-PIP01-09 - paediatric investigation plan
  692. Guidance document on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD
  693. 21 CFR 866.5715: Plasminogen immunological test system.
  694. Planning of the Pediatric Drug Development Program during Development of Drugs for Adults
  695. ACB meeting statement, Meeting 18, 24 February 2022
  696. Ergot-derived dopamine agonists - referral
  697. ema-axuraAxura
  698. Recombinant Human Follicle Stimulating Hormone Solution for Injection, 300 IU in…
  699. Natural Health Products Regulations (SOR/2003-196)
  700. 21 CFR 886.4790: Ophthalmic sponge.
  701. PSUSA/000010290/201507 - periodic safety update report single assessment
  702. EMA reorganisation: changes to handling of certain evaluation procedures for human…
  703. 21 CFR 870.5150: Embolectomy catheter.
  704. cdsco-20162016
  705. Serious adverse events from accidental ingestion by children of over-the-counter eye drops…
  706. EU/3/09/699 - orphan designation for treatment of chronic lymphocytic leukaemia
  707. cdsco-polatuzumab-vedotinPolatuzumab Vedotin
  708. Provisions for the Lot Release of Biological Products
  709. EMEA-002606-PIP02-19 - paediatric investigation plan
  710. EMEA-003235-PIP01-22 - paediatric investigation plan
  711. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.14) Regulations…
  712. 21 CFR 801.63: Medical devices; warning statements for devices containing or manufactured…
  713. Oxygen cylinders and their regulators: tips on how to handle them
  714. Velcade - withdrawal of application for variation to marketing authorisation
  715. Avenae herba - herbal medicinal product
  716. cdsco-elobixibatElobixibat
  717. ema-glivecGlivec
  718. cdsco-carbetocin-rtsCarbetocin RTS
  719. cdsco-kyprolis-carfilzomibKyprolis (Carfilzomib)
  720. EMEA-002812-PIP02-20-M02 - paediatric investigation plan
  721. EU/3/10/754 - orphan designation for treatment of traumatic spinal cord injury
  722. Markers used for quantitative and qualitative analysis of herbal medicinal products and…
  723. PSUSA/00002615/202004 - periodic safety update report single assessment
  724. EMEA-002318-PIP03-19 - paediatric investigation plan
  725. cdsco-vibegron-tablets-75-mgVibegron Tablets 75 mg
  726. 21 CFR 874.5220: Ear, nose, and throat drug administration device.
  727. Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication
  728. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical…
  729. Stakeholder Consultation on Operational Guidelines for Single Ethics Committee Review of…
  730. 21 CFR 870.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  731. EMEA-001576-PIP01-13 - paediatric investigation plan
  732. EU/3/16/1646 - orphan designation for treatment of multiple symmetric lipomatosis
  733. 21 CFR 56.109: IRB review of research.
  734. EMA closed 2 November 2020
  735. Kaisa Immonen elected as new co-chair of Patients' and Consumers' Working Party
  736. EMEA-000130-PIP01-07 - paediatric investigation plan
  737. Committee for Herbal Medicinal Products (HMPC): 18-20 November 2024
  738. Committee for veterinary medicinal products: 68th meeting
  739. Committee for Orphan Medicinal Products (COMP): 8-10 October 2024
  740. EMEA-002678-PIP01-19 - paediatric investigation plan
  741. International Women’s Day 2023: #EmbraceEquity: Evette Hillman, Molecular Biology “A…
  742. 21 CFR 800.10: Contact lens solutions; sterility.
  743. Propylene glycol and esters
  744. European Medicines Agency recommendation on the use of Linoladiol N and Linoladiol HN…
  745. cdsco-noticeNotice
  746. EMEA-001356-PIP02-12-M04 - paediatric investigation plan
  747. 21 CFR 866.3990: Gastrointestinal microorganism multiplex nucleic acid-based assay.
  748. PSUSA/00003175/201703 - periodic safety update report single assessment
  749. EU/3/13/1101 - orphan designation for treatment of moderate and severe traumatic brain…
  750. 68th meeting of the Committee for Proprietary Medicinal Products (CPMP)
  751. Committee for Medicinal Products for Human Use (CHMP): 23-26 June 2014
  752. Committee for Medicinal Products for Human Use (CHMP): 14-17 October 2019
  753. Regulation on Submission of Records and Documents of Medical Devices Subject to Tracking
  754. 21 CFR 822.33: How long must we keep the records?
  755. 21 CFR 870.2870: Catheter tip pressure transducer.
  756. EU/3/10/823 - orphan designation for treatment of familial chylomicronaemia
  757. brequinar combined dipyridamole
  758. EMEA-002189-PIP04-20 - paediatric investigation plan
  759. EU/3/13/1190 - orphan designation for treatment of plasma cell myeloma
  760. ema-luxceptarLuxceptar
  761. Annual Rate Contract for Hiring taxies 1 Last Date( 27 Jul 2012 )
  762. EU/3/16/1788 - orphan designation for treatment of N-acetylglutamate synthetase (NAGS)…
  763. cdsco-eq001EQ001
  764. Q&A about “Handling of the Two-step Approval Based on the Characteristics of Software as a…
  765. cdsco-trastuzumab-deruxtecanTrastuzumab Deruxtecan
  766. 21 CFR 882.1340: Nasopharyngeal electrode.
  767. Teriperatide Injection solution for injection in a pre-filled pen 600mcg/2.4ml (Synthetic…
  768. Renal Denervation RF Generator and Disposable Renal Denervation RF Ablation Catheter…
  769. Two additional manufacturing sites for BioNTech/Pfizer’s COVID-19 vaccine
  770. ema-quixidarQuixidar
  771. Efonidipine Hydrochloride Ethanolate + Telmisartan IP film coated bilayered tablet (Phase…
  772. PSUSA/00003017/202207 - periodic safety update report single assessment
  773. Dinesh Katiyar: Critical Steps for Securing IoMT Devices
  774. EMEA-001410-PIP01-12 - paediatric investigation plan
  775. EU/3/06/382 - orphan designation for treatment of renal-cell carcinoma
  776. Second European Medicines Agency (EMA) and European Confederation of Pharmaceutical…
  777. 2018.07.11_S.O.3400 (E)_ Notification of Medical Device Testing Officers (MDTO)
  778. Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018
  779. ema-erveboErvebo
  780. Measles (Edmonston Zagreb) and Rubella (RA27/3) Vaccine Live, Attenuated (Freeze Dried)…
  781. First long-acting injectable antiretroviral therapy for HIV recommended for approval
  782. Pilosellae herba cum radice - herbal medicinal product
  783. Team-NB-Statement-20171120
  784. EU/3/14/1385 - orphan designation for treatment of pancreatic cancer
  785. Russell Furst: Both Management and Leadership Matter
  786. S.O.1511(E) Dt. 18.05.2020_Regulations for manufacture and stock of vaccines for…
  787. 2026.04.10_ G.S.R. 270(E)_Draft Notification to amend certain provisions under Medical…
  788. PSUSA/00003043/201708 - periodic safety update report single assessment
  789. EMEA-001558-PIP02-14 - paediatric investigation plan
  790. Autologous human cells and tissues products regulation
  791. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17…
  792. 21 CFR 862.3840: Sirolimus test system.
  793. EU/3/16/1751 - orphan designation for treatment of peripheral T-cell lymphoma
  794. A 'Call for Action' in Training BMETs in Low-Resource Countries
  795. 21 CFR 26.12: Nature of recognition of inspection reports.
  796. VICH GL13 Efficacy of anthelmintics: specific requirements for ovines - Scientific…
  797. Xeljanz - direct healthcare professional communication (DHPC)
  798. ema-fabrazymeFabrazyme
  799. Info day for micro, small and medium-sized enterprises (SMEs): EMA support for SMEs under…
  800. AAMI’s Health Technology Collection Puts Innovation on Display
  801. Committee for Herbal Medicinal Products (HMPC): 19-21 January 2026
  802. ema-equitendEquitend
  803. Annex I variation application(s) content for live attenuated influenza vaccines
  804. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April…
  805. cdsco-sotagliflozinSotagliflozin
  806. EU/3/19/2147 - orphan designation for treatment of primary sclerosing cholangitis
  807. ema-amvuttraAmvuttra
  808. Otsuka Pharmaceutical Europe Ltd withdraws its application for an extension of indication…
  809. ema-rR
  810. EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular…
  811. Streamlining Management of Postmarket Security Vulnerabilities
  812. Clinical investigation of human plasma-derived von Willebrand factor products - Scientific…
  813. EMEA-001371-PIP02-21 - paediatric investigation plan
  814. ICH Q1F Stability data package for registration in climatic zones III and IV - Scientific…
  815. Classification of Medical Device pertaining to Personal Protective Equipment under the…
  816. PSUSA/00010542/201912 - periodic safety update report single assessment
  817. 21 CFR 12.22: Filing objections and requests for a hearing on a regulation or order.
  818. Committee for medicinal products for veterinary use: Meeting of 10 to 12 October 2006
  819. ema-zinbryta-referralZinbryta - referral
  820. EMEA-002282-PIP01-17-M01 - paediatric investigation plan
  821. 21 CFR 882.1950: Tremor transducer.
  822. Introduction to Referentials Management Service (RMS): Industry webinar
  823. AAMI Releases New Strategic Plan, a Roadmap for the Future
  824. Taraxaci folium - herbal medicinal product
  825. European Commissioner for Health and Food Safety visits EMA
  826. Adrenaline Auto-Injectors (AAIs) safety campaign: The correct use of your Adrenaline…
  827. cdsco-camizestrant-azd9833Camizestrant AZD9833
  828. cdsco-ino-4800INO-4800
  829. GN-08-R2 Guidance on Medical Device Advertisements and Sales Promotion
  830. 21 CFR 803.9: What information from the reports do we disclose to the public?
  831. 21 CFR 886.1925: Diurnal pattern recorder system.
  832. EU/3/24/2909 - orphan designation for treatment of spinal cord injury
  833. Training on electronic submission of information on medicines - new pharmacovigilance…
  834. EMEA-002599-PIP01-19-M01 - paediatric investigation plan
  835. EU/3/20/2293 - orphan designation for treatment of Becker muscular dystrophy
  836. ema-rizmoicRizmoic
  837. cfr-21-cfr-1-70-scope21 CFR 1.70: Scope.
  838. EMEA-003285-PIP01-22 - paediatric investigation plan
  839. Drug Alert list for month of March 2019
  840. EU/3/16/1682 - orphan designation for treatment of necrotising enterocolitis
  841. New gene therapy to treat rare inherited blood condition
  842. Salviae trilobae folium - herbal medicinal product
  843. PSUSA/00000906/201705 - periodic safety update report single assessment
  844. ema-zynrelefZynrelef
  845. cdsco-advertisement-of-adiAdvertisement of ADI
  846. Committee for Proprietary Medicinal Products (CPMP) 47th plenary meeting
  847. ema-evanovoEvanovo
  848. 21 CFR 99.305: Exemption from the requirement to file a supplemental application.
  849. (In Japanese)Contents and format of a study protocol for Post-marketing Database Study
  850. Meeting highlights from the Committee for Medicinal Products for Human Use, 18-21…
  851. Infographic - Become an Authorised Prescriber for nicotine vaping products
  852. A Look Ahead: What to Expect in AAMI Standards in 2022
  853. cdsco-bi-690517BI 690517
  854. Questions and Answers (Q&A) on Guideline for Ensuring the Quality, Safety, and Efficacy of…
  855. Information sources that could assist regulators with market authorisation of…
  856. EMEA-001278-PIP01-12 - paediatric investigation plan
  857. European Medicines Agency website unavailable 20-22 September 2013
  858. 21 CFR 878.4730: Surgical skin degreaser or adhesive tape solvent.
  859. ema-pulmotil-ac-referralPulmotil AC - referral
  860. ema-menveoMenveo
  861. Tocilizumab 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL
  862. ema-allexAllex
  863. EMEA-001511-PIP03-14 - paediatric investigation plan
  864. Drugs Alert for the month of May 2016
  865. 21 CFR 884.6110: Assisted reproduction catheters.
  866. 21 CFR 12.97: Interlocutory appeal from ruling of presiding officer.
  867. ema-sotyktuSotyktu
  868. ema-purevax-rcpch-felvPurevax RCPCh FeLV
  869. 21 CFR 1.1142: How does a laboratory request reinstatement of LAAF-accreditation?
  870. IMDRF Clears the Air on Key Artificial Intelligence Terms
  871. 21 CFR 864.7720: Prothrombin consumption test.
  872. EU/3/07/456 - orphan designation for treatment of cryopirin-associated periodic syndromes
  873. PSUSA/00002832/201409 - periodic safety update report single assessment
  874. 21 CFR 1.230: When must you register or renew your registration?
  875. IT systems unavailable from 30 March to 1 April 2019
  876. New oral treatment for moderate to severe atopic dermatitis
  877. Mulpleo (previously Lusutrombopag Shionogi)
  878. ema-thyrogenThyrogen
  879. SARS-Cov2-rs Protein recombinant spike protein nanoparticle vaccine
  880. Pharmaceutical development of medicines for paediatric use - Scientific guideline
  881. EU/3/15/1478 - orphan designation for treatment of Duchenne muscular dystrophy
  882. European Medicines Agency IT systems unavailable from 30 October to 3 November 2015
  883. cdsco-concizumab-prophylaxisConcizumab Prophylaxis
  884. ema-prehevbriPreHevbri
  885. cdsco-selonsertib-nashSelonsertib NASH
  886. ema-ariclaimAriclaim
  887. Inspection of Licensed In-Vitro Diagnostic (IVD) Devices
  888. Insulin Lispro Ultrarapid(UR) Injection
  889. PSUSA/00001316/202303 - periodic safety update report single assessment
  890. Applying regulatory science to neonates: launch of the International Neonatal Consortium…
  891. EMEA-001478-PIP01-13 - paediatric investigation plan
  892. Similar biological medicinal products containing monoclonal antibodies: non-clinical and…
  893. AAMI Awards Honor Standards Developers, Technical Committees
  894. Validation of Aseptic Processes
  895. ema-masivetMasivet
  896. Handbook for Preparation of Summary Technical Documentation Submitted in Applications for…
  897. European Medicines Agency and EUnetHTA Joint Action start collaboration on European Public…
  898. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 January 2024
  899. ema-inrebicInrebic
  900. EMEA-001969-PIP01-16 - paediatric investigation plan
  901. EU/3/24/2944 - orphan designation for treatment of non-syndromic inherited retinal…
  902. PSUSA/00001979/202303 - periodic safety update report single assessment
  903. 21 CFR 20.86: Disclosure in administrative or court proceedings.
  904. EMEA-001983-PIP01-16-M01 - paediatric investigation plan
  905. EMEA-001893-PIP01-15-M02 - paediatric investigation plan
  906. cdsco-plecanatidePlecanatide
  907. ICH S8 Immunotoxicity studies for human pharmaceuticals - Scientific guideline
  908. Committee for Orphan Medicinal Products (COMP): 4-6 November 2025
  909. Publication of a Gazette Notification of Drugs Inspector in CDSCO under Section 21 of D&C…
  910. Expressions of interest invited for workshop on medicines for older people
  911. EMEA-001080-PIP01-10 - paediatric investigation plan
  912. 21 CFR 860.136: Procedures for transitional products under section 520(l) of the Federal…
  913. Eighth stakeholders forum on the implementation of the pharmacovigilance legislation…
  914. A Framework for a Medical Device Security Program at a Healthcare Delivery Organization
  915. PSUSA/00001825/202211 - periodic safety update report single assessment
  916. PSUSA/00002166/201811 - periodic safety update report single assessment
  917. EMEA-001640-PIP01-14-M06 - paediatric investigation plan
  918. EU authorities agree new measures to support availability of medicines used in the…
  919. PSUSA/00002217/202102 - periodic safety update report single assessment
  920. Notice regarding Import of Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or…
  921. 21 CFR 862.1165: Catecholamines (total) test system.
  922. ema-iplexIplex
  923. EMEA-001910-PIP01-15 - paediatric investigation plan
  924. EMEA-001816-PIP01-15 - paediatric investigation plan
  925. 21 CFR 872.6390: Dental floss.
  926. 21 CFR 866.2660: Microorganism differentiation and identification device.
  927. February 25-26, 2016: Gastroenterology and UrologyDevices Panel of the Medical Devices…
  928. New recommendations to minimise risks of the rare brain infection PML and a type of skin…
  929. Medical Devices alert for Ventilator of Philips August 2021
  930. Filipendulae ulmariae herba - herbal medicinal product
  931. Regulation for the Issuance and Management of Western Pharmaceuticals Distribution…
  932. Fourth meeting of the EMEA Human Scientific Committees' Working Party with with Patients'…
  933. European Medicines Agency and Medicines for Europe annual bilateral meeting 2017
  934. EMEA-002072-PIP01-16-M01 - paediatric investigation plan
  935. Annex1 Guideline on Bioanalytical Method Validation in Pharmaceutical Development,Annex2…
  936. AstraZeneca withdraws its application for Ximelagatran 36-mg film-coated tablets
  937. Committee for Medicinal Products for Human Use (CHMP): 22-25 April 2024
  938. EMEA-001382-PIP01-12 - paediatric investigation plan
  939. European Medicines Agency starts new review of cardiovascular risks of non-selective…
  940. Food-Medicine Interface Guidance Tool questions - explanation and information
  941. MEA-002970-PIP01-21 - paediatric investigation plan
  942. EMEA-001465-PIP01-13-M05 - paediatric investigation plan
  943. EU/3/07/471 - orphan designation for treatment of hereditary factor X deficiency
  944. October 12, 2018: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee…
  945. cfr-21-cfr-21-3-definitions21 CFR 21.3: Definitions.
  946. Public Notice regarding DCGI meeting with Stakeholders Dated 15.04.2024 for 2nd and 4th…
  947. Nicotine Vaping Product Analysis: Evidence from the University of Wollongong
  948. 21 CFR 870.1200: Diagnostic intravascular catheter.
  949. Silodosin JP 8mg (as film coated tablet) + Tadalafil IP 5mg (as film coated tablet) hard…
  950. EU/3/20/2370 - orphan designation for treatment of hepatocellular carcinoma
  951. European Medicines Agency updates on ongoing benefit-risk review of Multaq
  952. PSUSA/00003067/201707 - periodic safety update report single assessment
  953. Biphasic Isophane insulin
  954. Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety…
  955. 2026.05.13 G.S.R. 377(E)_Notification for amendment in Schedule H1 for inclusion of…
  956. Glimepiride IP + Voglibose IP + Metformin HCl IP (as ER) uncoated bilayered tablet (Phase…
  957. Ministerial Order on the Standard of Quality Management for Pharmaceuticals…
  958. Bob Zemke and Ali Youssef: Tips for Managing Wireless Medical Devices
  959. Cosmetic Breast Augmentation Risk Awareness Tool
  960. Ken Hoyme: Systems Thinkers, Engineers, and a Systems Approach All Have a Role to Play
  961. EU/3/19/2233 - orphan designation for treatment of myelofibrosis
  962. cdsco-crizanlizumabCrizanlizumab
  963. EMEA-000436-PIP01-08 - paediatric investigation plan
  964. 21 CFR 862.1270: Estrogens (total, in pregnancy) test system.
  965. Paeoniae radix alba - herbal medicinal product
  966. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  967. PSUSA/00000494/202106 - periodic safety update report single assessment
  968. PSUSA/00010292/201603 - periodic safety update report single assessment
  969. ema-kexxtoneKexxtone
  970. ema-alkindiAlkindi
  971. EU/3/15/1453 - orphan designation for treatment of Huntington’s disease
  972. Shirahata Y. Current regulation on CMC of Biopharmaceuticals in Japan. Global Bio…
  973. Towards electronic product information for EU medicines
  974. Veterinary medicines: Highlights of 2023
  975. Notice regarding consideration of the directions of the Hon'ble Supreme Court of India in…
  976. COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines
  977. ema-fellowshipsFellowships
  978. ema-broadlineBroadline
  979. ema-proteqfluProteqFlu
  980. 21 CFR 864.5680: Automated heparin analyzer.
  981. UPDATE: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology…
  982. 21 CFR 810.3: Computation of time.
  983. DR_G.S.R. 52(E) dt_27.01.2020_Exemption of Import of Oxytocin reference standards from…
  984. 21 CFR 56.106: Registration.
  985. 21 CFR 876.1050: Endoscopic transhepatic venous access needle.
  986. GMP Clearance questionnaire
  987. Reflecting on Cybersecurity and Patient Safety
  988. 30th meeting of the committee for veterinary medicinal products
  989. EMEA-003318-PIP01-22 - paediatric investigation plan
  990. PSUSA/00010442/201707 - periodic safety update report single assessment

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