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Global regulations and guidance

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

  1. Heads of Medicines Agencies
  2. EU/3/14/1309 - orphan designation for treatment of Duchenne muscular dystrophy
  3. Wyeth Europa Limited withdraws its marketing authorisation application for Brilence
  4. 2022.02.01_ Draft GSR 75(E)_Inclusion of Acitretin in Sch H of Drugs Rules 1945
  5. ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals - Scientific…
  6. EMEA-002229-PIP01-17-M03 - paediatric investigation plan
  7. cdsco-chemotherapyChemotherapy
  8. Naxitamab and Sargramostim
  9. Procurement activities 2019
  10. EMEA-001518-PIP03-19 - paediatric investigation plan
  11. 21 CFR 862.1325: Gastrin test system.
  12. New video launched: How does EMA support SMEs?
  13. EU/3/17/1836 - orphan designation for treatment of Lennox-Gastaut syndrome
  14. Compliance: overview (veterinary medicines)
  15. Provisions for Administration of Medical Device Recall
  16. Questions and Answers (Q&A) on the Operation of the Standards for Biological Raw Materials
  17. P0003.004: MDSAP Roles and Responsibilities
  18. cdsco-dacomitinib-tab-15-rmDacomitinib tab 15 rm
  19. NMPA Announcement on the Issuance of 13 Guidelines for Technical Review of the…
  20. Regulations for Management of Medical Device Safety Surveillance, Medical Device Periodic…
  21. Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 November 2020
  22. Committee for advanced therapies – election of new chair, overview of 2013 and looking…
  23. "Delafloxacin Tablets 450 mg Delafloxacin for Injection 300 mg/vial "
  24. Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 December 2021
  25. How the EU regulates medicines
  26. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July…
  27. Medical Device Alert Dated 20.05.2019
  28. 'Represent the Future,' Urge AAMI Scholarship Recipients
  29. ema-veyvondiVeyvondi
  30. Committee for Orphan Medicinal Products (COMP): 16-18 January 2024
  31. Favipiravir tablet 400 mg
  32. mhra-mhra-fees-fees-extractsMHRA fees: Fees extracts
  33. ema-tritazide-referralTritazide - referral
  34. EU/3/23/2763 - orphan designation for treatment of scedosporiosis
  35. European Medicines Agency closed 9 May 2017
  36. PSUSA/00010593/201903 - periodic safety update report single assessment
  37. EU/3/10/749 - orphan designation for treatment of haemophagocytic lymphohistiocytosis
  38. ema-nezglyalNezglyal
  39. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  40. European Medicines Agency makes recommendations for safer use of Ritalin and other…
  41. Notice regarding all implantable devices
  42. Effective Maintenance Plans Save Lives, and BMETs Are a Vital Component for Success
  43. eXtended EudraVigilance Medicinal Product Dictionary training course
  44. EU/3/15/1486 - orphan designation for treatment of retinitis pigmentosa
  45. 21 CFR 1.283: What happens to food that is imported or offered for import without adequate…
  46. EU/3/23/2773 - orphan designation for treatment of hyperphenylalaninaemia
  47. PSUSA/00002695/201701 - periodic safety update report single assessment
  48. Allergenic potency of herbal medicinal products containing soya or peanut protein…
  49. PSUSA/00002104/201503 - periodic safety update report single assessment
  50. 2025.02.11 G.S.R. 127(E) Notification reg Extension of timeline for implementation of…
  51. GN 16-R1.2 Guidance on Essential Principles for Safety and Performance of Medical Devices…
  52. PSUSA/00010287/202111 - periodic safety update report single assessment
  53. Public Notice regarding online portal SUGAM
  54. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - December 2015
  55. GN-21-R5 Guidance on Change Notification for Registered MD (2023 Mar) PUB
  56. DR_G.S.R. 19(E) dt_10.01.2019_Provosion for information to be uploaded by licensee on…
  57. Guidance for Industry_Post-marketing Vigilance Requirements for Therapeutic Products and…
  58. EU/3/23/2857 - orphan designation for treatment of ovarian cancer
  59. 21 CFR 886.1660: Gonioscopic prism.
  60. FDA Is Requiring Warning about Vitamin B6 Deficiency and Associated Seizures for Drug…
  61. Specifications: test procedures and acceptance criteria for herbal substances, herbal…
  62. Proline - Scientific guideline
  63. cdsco-sar442168SAR442168
  64. EMA closed from 28 October to 3 November 2016
  65. cdsco-pln-74809PLN-74809
  66. EMEA-000157-PIP01-07-M05 - paediatric investigation plan
  67. EMEA-001232-PIP01-11 - paediatric investigation plan
  68. Non-clinical and clinical development of medicinal products for the treatment of nausea…
  69. PSUSA/00001860/202201 - periodic safety update report single assessment
  70. Drug Alert list for month of May 2021
  71. Meeting highlights from the Paediatric Committee held by written procedure: 19 - 21 August…
  72. 21 CFR 56.104: Exemptions from IRB requirement.
  73. Guidance document: Applications for Medical Device Investigational Testing Authorizations…
  74. Committee for Medicinal Products for Human Use (CHMP): 08-11 December 2025
  75. Tropicamide IP + Phenylephrine Hydrochloride IP + Lidocaine Hydrochloride IP injection…
  76. Meeting highlights from the Committee for Medicinal Products for Human Use,23-26 April…
  77. 21 CFR 886.4350: Manual ophthalmic surgical instrument.
  78. PSUSA/00010572/201806 - periodic safety update report single assessment
  79. EU/3/24/2956 - orphan designation for treatment of cystic fibrosis
  80. Refusal of orphan designation for treatment of narcolepsy
  81. EMEA-002608-PIP01-19 - paediatric investigation plan
  82. FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and…
  83. Intention to Invoke Section 37 of the Food and Drugs Act for Products being Exported…
  84. EU/3/04/216 - orphan designation for respiratory distress syndrome in premature neonates…
  85. EU/3/07/442 - orphan designation for treatment of diffuse large B-cell lymphoma
  86. UPDATED PUBLIC PARTICIPATION INFORMATION: October 11, 2018: Meeting of the Anesthetic and…
  87. Drug Safety Update: monthly PDF newsletter: Drug Safety Update August 2020
  88. EU/3/18/2040 - orphan designation for treatment of pre-eclampsia
  89. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - March 2016
  90. PSUSA/00010230/202111 - periodic safety update report single assessment
  91. EMA to host workshop on prevention of product shortages due to manufacturing and quality…
  92. 21 CFR 80.10: Fees for certification services.
  93. ema-btvpur-alsap-8BTVPUR Alsap 8
  94. EU/3/16/1638 - orphan designation for treatment of pulmonary arterial hypertension
  95. PSUSA/ 00009057/202101 - periodic safety update report single assessment
  96. EU/3/03/132 - orphan designation for treatment of primary apnoea of premature newborns
  97. Pegfilgrastim Injection 6mg
  98. Revefenacin Inhalation Solution 175 mcg/3ml cipla
  99. cdsco-osimertinibosimertinib
  100. EMEA-002593-PIP01-19 - paediatric investigation plan
  101. PSUSA/00010376/201704 - periodic safety update report single assessment
  102. 21 CFR 892.1370: Nuclear anthropomorphic phantom.
  103. PSUSA/00002207/201610 - periodic safety update report single assessment
  104. cdsco-trastuzumabnnTrastuzumabnn
  105. cdsco-20122012
  106. 21 CFR 866.3460: Rabiesvirus immunofluorescent reagents.
  107. Points to Consider When Applying for Marketing Approval of In Vitro Diagnostics
  108. FDA Launches Initiative to Boost Small Medtech Businesses
  109. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations…
  110. nbcg-team-nb-press-releaseTEAM-NB Press Release
  111. Manufacturing and marketing of unapproved drug Meropenem & Disodium EDTA for Injection
  112. NMPA Issued Guidelines for Technical Review of the Registration of Custom-Made and…
  113. Enpr-EMA Coordinating Group meeting June 2024
  114. EMEA-002029-PIP01-16-M03 - paediatric investigation plan
  115. How to ensure that novel analytic methods are fit for decision-making
  116. Illegal Sale of Potentially Unsafe Hand-held Dental X-Ray Units: FDA Safety Communication…
  117. EU/3/09/668 - orphan designation for treatment of angioedema caused by C1 inhibitor…
  118. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 August 2011
  119. EMEA-001191-PIP01-11-M03 - paediatric investigation plan
  120. EU/3/16/1625 - orphan designation for treatment of mantle cell lymphoma
  121. European Medicines Agency stakeholder interaction on the development of medicinal products…
  122. PSUSA/00002087/201507 - periodic safety update report single assessment
  123. Meeting highlights from the Paediatric Committee: 21 - 23 November 2007
  124. 21 CFR 868.2600: Airway pressure monitor.
  125. 21 CFR 20.118: Advisory committee records.
  126. Extension of validity of WHO GMP/Certificate of Pharmaceutical Product (COPP)
  127. Committee for Orphan Medicinal Products (COMP): 20-22 January 2026
  128. Prescription status of edaravone and personal importation: Notice of update
  129. ema-dopteletDoptelet
  130. QMS P0009.006: Nonconformity and Corrective Action Procedure
  131. EU/3/10/785 - orphan designation for treatment of malignant mesothelioma
  132. Fluorouracil / salicylic acid - paediatric investigation plan
  133. Computerized Systems in the Food Processing Industry
  134. EU/3/09/724 - orphan designation for treatment of chronic non-infectious uveitis
  135. EudraVigilance training on electronic reporting of ICSRs in the EEA
  136. 21 CFR 884.2960: Obstetric ultrasonic transducer and accessories.
  137. EMEA-001301-PIP02-12-M04 - paediatric investigation plan
  138. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - September…
  139. ICH M10 on bioanalytical method validation - Scientific guideline
  140. cdsco-ds-5565DS-5565
  141. FDA warns about potential medication errors resulting from confusion regarding…
  142. ema-moventigMoventig
  143. Second workshop for the EMEA/CHMP Working Group with Patients' Organisations
  144. Facilitating applications for paediatric investigation plans
  145. EMEA-001624-PIP01-14-M06 - paediatric investigation plan
  146. Potency testing of cell based immunotherapy medicinal products for the treatment of cancer
  147. ema-truberziTruberzi
  148. Team-NB-List-PositionPapers-20240702
  149. 2022.01.18_Final GSR 19(E)_Amendment in rules 19B, 19C,19D &19E of MDR 2017
  150. June 28, 2023 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting…
  151. EU/3/18/2013 - orphan designation for treatment of diffuse large B-cell lymphoma
  152. Appendix 6 Guideline on Submission for Non-Prescription Therapeutic Products
  153. Mary Logan: Whose World View Do We Use to Define and Manage Risk?
  154. Global regulators stress need for robust evidence on COVID-19 treatments
  155. EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
  156. EU/3/15/1601 - orphan designation for treatment of argininosuccinic aciduria
  157. Compliance: post-authorisation (veterinary medicines)
  158. Falsified medicines: overview
  159. Designation of CMDTL & MDTL including IVDMD under MDR-2017
  160. New judicial decisions at odds with EMA's efforts to allow access to documents on…
  161. Regulatory information – adjustment of linguistic review timetable for opinions adopted at…
  162. Intended use: Interpretation of homologous use
  163. EU/3/22/2684 - orphan designation for treatment of myasthenia gravis
  164. PSUSA/00001512/201603 - periodic safety update report single assessment
  165. EMEA-003212-PIP01-22 - paediatric investigation plan
  166. PSUSA/00002192/201803 - periodic safety update report single assessment
  167. PSUSA/00000715/202005 - periodic safety update report single assessment
  168. Committee for Advanced Therapies (CAT): 19-21 April 2023
  169. EMEA-002982-PIP01-21 - paediatric investigation plan
  170. 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis.
  171. EU/3/17/1873 - orphan designation for treatment of paroxysmal nocturnal haemoglobinuria
  172. EMEA-001613-PIP04-21 - paediatric investigation plan
  173. EMEA-001526-PIP01-13-M06 - paediatric investigation plan
  174. PSUSA/00001614/202103 - periodic safety update report single assessment
  175. PSUSA/00010298/201903 - periodic safety update report single assessment
  176. EMEA-000013-PIP01-07-M03 - paediatric investigation plan
  177. First CAR-T cell medicine for mantle cell lymphoma
  178. EMEA-001990-PIP01-16-M05 - paediatric investigation plan
  179. Judgement by European Union Civil Service Tribunal on appointment procedure of EMA…
  180. cdsco-bhv-7000-ppdBHV-7000 PPD
  181. Committee for Advanced Therapies (CAT): 3-5 December 2025
  182. EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed…
  183. Sterilization Leaders Pool Knowledge in Unprecedented Collaboration
  184. EU/3/19/2170 - orphan designation for treatment of beta thalassaemia intermedia and major
  185. EMEA-003003-PIP01-21 - paediatric investigation plan
  186. 21 CFR 890.3790: Cane, crutch, and walker tips and pads.
  187. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 July 2010
  188. ema-compliance-overviewCompliance: Overview
  189. A global approach to regulatory flexibility to increase manufacturing capacity during…
  190. EMEA-000713-PIP02-10-M05 - paediatric investigation plan
  191. European Medicines Agency closed 24 December 2012 to 2 January 2013
  192. EMEA-002565-PIP02-19 - paediatric investigation plan
  193. Conflicts of interests: revised EMA policy reflects more balanced approach
  194. Medical Devices Establishment Licence Listing (MDEL)
  195. Drug Alert list for month of September 2015
  196. 21 CFR 866.3395: Norovirus serological reagents.
  197. Act on In Vitro Diagnostic Medical Devices
  198. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical…
  199. MDS - G5: Guidance on Requirements for Medical Device Listing and Marketing Authorization
  200. 21 CFR 21.52: Administrative appeals of refusals to amend records.
  201. Training session on Human variations web-based electronic Application Form (eAF) for…
  202. Telmisartan IP + Bisoprolol Fumarate IP tablets (Phase III)
  203. 21 CFR 872.3930: Bone grafting material.
  204. New oral treatment for rheumatoid arthritis
  205. ema-daronrixDaronrix
  206. 2017 annual workshop of the European network of paediatric research at the European…
  207. 21 CFR 822.22: What recourse do I have if I do not agree with your decision?
  208. EU/3/04/221 - orphan designation for treatment of pancreatic cancer in combination with…
  209. ema-innovax-nd-h5Innovax-ND-H5
  210. Notice-dated 28.08.2012: Expansion of Experts panel for evaluation of application of New…
  211. ema-risk-managementRisk management
  212. EMEA-001710-PIP03-17-M03 - paediatric investigation plan
  213. Consent requirements for clinical trials involving collection of human tissue
  214. PSUSA/00001475/201507 - periodic safety update report single assessment
  215. Clinical trials in small populations - Scientific guideline
  216. 8th meeting of the Committee for Orphan Medicinal Products
  217. EU/3/19/2150 - orphan designation for treatment of cystic fibrosis
  218. 21 CFR 882.4460: Neurosurgical head holder (skull clamp).
  219. AstraZeneca’s COVID-19 vaccine: benefits and risks in context
  220. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19…
  221. Drug Alert for the Month of February 2024
  222. Union Product Database: webinar on variations not requiring assessment (VNRAs) for…
  223. Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)
  224. EU/3/08/535 - orphan designation for treatment of ovarian cancer
  225. Simplification of submission of applications for centrally authorised medicines
  226. System of preliminary scrutiny by C.D.S.C.O at the time of receipt of application for…
  227. Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding…
  228. Pharmacovigilance Risk Assessment Committee (PRAC): 28-31 October 2019
  229. 21 CFR 866.2580: Gas-generating device.
  230. EMEA-002500-PIP01-18 - paediatric investigation plan
  231. NOTICE regarding the SLP No.7061/2017 titled under Union of India Vs Pfizer and Ors and…
  232. EU/3/17/1966 - orphan designation for treatment of small cell lung cancer
  233. EMEA-000715-PIP03-11-M06 - paediatric investigation plan
  234. EMEA-000341-PIP02-09-M05 - paediatric investigation plan
  235. EMEA-002250-PIP02-17-M01 - paediatric investigation plan
  236. Adjusted fees for applications to European Medicines Agency on 1 April 2011
  237. 21 CFR 807.26: Additional listing information.
  238. P/25/2011 - paediatric investigation plan
  239. Plastic primary packaging materials - Scientific guideline
  240. ema-binocritBinocrit
  241. Committee for Medicinal Products for Human Use (CHMP): 23-26 February 2015
  242. AI Airlock Phase 2 application
  243. EMEA-003398-PIP01-23 - paediatric investigation plan
  244. EMEA-001953-PIP01-16 - paediatric investigation plan
  245. Regulatory guidance for industry to prepare for the UK's withdrawal from the EU
  246. PSUSA/00001444/202311 - periodic safety update report single assessment
  247. Regulatory guidelines for development of Vaccine 21.09.2020
  248. 21 CFR 886.1655: Ophthalmic Fresnel prism.
  249. ema-ultomirisUltomiris
  250. European Medicines Agency recommends suspension of the marketing authorisation of Raptiva…
  251. 21 CFR 884.5920: Vaginal insufflator.
  252. Sterilization Standards Leaders Share Insights on Three New Documents
  253. Paediatric Committee (PDCO): 10-12 December 2014
  254. Regulations Governing Border Inspection and Examination of Imported Medical Devices…
  255. Request form for unregistered medical device for use on patients by QP and Licensed…
  256. Regulation on Prior Review of Advertisement on Medical Device
  257. ema-clopidogrel-bmsClopidogrel BMS
  258. EMEA-003291-PIP01-22 - paediatric investigation plan
  259. First hormone replacement therapy for parathyroid disorder
  260. Workshop on single-arm trials in oncology
  261. Committee for medicinal products for veterinary use: Meeting of 16-18 September 2008
  262. PSUSA/00010685/202312 - periodic safety update report single assessment
  263. PSUSA/00002449/202104 - periodic safety update report single assessment
  264. Cilnidipine IP Azilsartan Kamedoxomil eq. to Azilsartan Medoxomil tablets
  265. EMEA-002416-PIP01-18 - paediatric investigation plan
  266. EMEA-001218-PIP01-11 - paediatric investigation plan
  267. Atropine Sulfate Ophthalmic Solution USP 0.01% w/v
  268. Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical…
  269. Clinical efficacy and safety: alimentary tract and metabolism
  270. PSUSA/00002834/202008 - periodic safety update report single assessment
  271. PSUSA/00000131/202209 - periodic safety update report single assessment
  272. ema-efexor-depot-referralEfexor depot - referral
  273. PSUSA/00000997/201510 - periodic safety update report single assessment
  274. Better labelling of excipients for safe use of medicines
  275. EMEA sets out its road map to 2010
  276. European Medicines Agency concludes on use of celecoxib in familial adenomatous polyposis
  277. Not Of Standard of Quality (NSQ) ALERT FOR THE MONTH OF April-2025
  278. 21 CFR 866.5130: Alpha-1-antitrypsin immunological test system.
  279. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  280. ema-varromedVarroMed
  281. ema-exulettExulett
  282. 21 CFR 26.47: Role and composition of the Joint Sectoral Committee.
  283. EU/3/24/2955 - orphan designation for treatment of peripheral T-cell lymphoma
  284. Seretide Evohaler - referral
  285. Core summary of product characteristics for human plasma-derived and recombinant…
  286. P/0323/2014 - paediatric investigation plan
  287. ema-naxcelNaxcel
  288. GN-21-R4.4 Guidance on Change Notification for Registered Medical Device [ARCHIVED on 31…
  289. EMEA-003155-PIP01-21 - paediatric investigation plan
  290. European Immunisation Week: Statement of Guido Rasi, the Executive Director of the…
  291. cdsco-hydrochloroquineeHydrochloroquinee
  292. 21 CFR 862.1177: Cholylglycine test system.
  293. Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic…
  294. Patients/Consumers Working Party (PCWP) and Healthcare Professionals Working Group (HCP…
  295. EMEA-003114-PIP01-21 - paediatric investigation plan
  296. Committee for Advanced Therapies (CAT): 10-12 October 2018
  297. Notice issued by DCG(I) regarding implementation of SUGAM Online system for reporting of…
  298. PSUSA/00010473/202203 - periodic safety update report single assessment
  299. ema-ryzneutaRyzneuta
  300. ema-halimatozHalimatoz
  301. Dapagliflozin propanediol Monohydrate eq. to Dapagliflozin + Linagliptin + Metformin…
  302. cdsco-trastuzumabTrastuzumab
  303. 21 CFR 1.383: What expedited procedures apply when FDA initiates a seizure action against…
  304. 21 CFR 862.3640: Morphine test system.
  305. 21 CFR 56.122: Public disclosure of information regarding revocation.
  306. Paediatric Committee (PDCO): 30 March – 1 April 2016
  307. EMEA-001501-PIP08-20 - paediatric investigation plan
  308. Guideline on the summary of product characteristics (SPC) for veterinary medicinal…
  309. DR_G.S.R. 100(E) dt_11.02.2003_26A_Reg FDC of Rifamicin, INH and Pyrazinamide
  310. European Medicines Agency review concludes positive benefit-risk balance for non-selective…
  311. 21 CFR 866.3360: Lymphocytic choriomeningitis virus serological reagents.
  312. 21 CFR 14.155: Fees and compensation pertaining to a color additive advisory committee.
  313. EU/3/16/1741 - orphan designation for treatment of retinitis pigmentosa
  314. cdsco-inotuzumabInotuzumab
  315. 21 CFR 1.928: What process will we follow when waiving a requirement of this subpart on…
  316. PSUSA/00001744/202003 - periodic safety update report single assessment
  317. GN-09-R3.6 Guidance on the Component Elements of a DHCPL (2022 May) PUB
  318. Section 19A: Guidance for industry
  319. European Medicines Agency updates on pandemic influenza
  320. FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of…
  321. EMEA-002901-PIP01-20 - paediatric investigation plan
  322. 21 CFR 868.1780: Inspiratory airway pressure meter.
  323. EMEA-002024-PIP01-16 - paediatric investigation plan
  324. Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A…
  325. Efonidipine Hydrochloride Ethanolate + Chlorthalidone IP uncoated bilayered tablets (Phase…
  326. 21 CFR 872.3600: Partially fabricated denture kit.
  327. Keytruda - withdrawal of application for variation to marketing authorisation
  328. Committee for Orphan Medicinal Products (COMP): 4-6 February 2014
  329. PSUSA/00010561/202206 - periodic safety update report single assessment
  330. Notice of Advisory for registration of blood centres on E-rakhtkosh
  331. VICH GL47 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in…
  332. PSUSA/00000459/201707 - periodic safety update report single assessment
  333. European SME Week - supporting a major driver of innovation
  334. ema-benepaliBenepali
  335. mhra-make-a-payment-to-mhraMake a payment to MHRA
  336. Guidance Document: Information to be Provided by Manufacturers for the Reprocessing and…
  337. 21 CFR 861.5: Statement of policy.
  338. Kuribayashi R. Regulatory Experience and Considerations to Date from PMDA. IPRP Biosimilar…
  339. 21 CFR 882.4845: Powered rongeur.
  340. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  341. EU/3/09/651 - orphan designation for treatment of atopic keratoconjunctivitis
  342. EU/3/21/2539 - orphan designation for treatment of SCN2A developmental and epileptic…
  343. EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory framework
  344. ema-emea-efpia-info-dayEMEA - EFPIA info - day
  345. Contusugene Ladenovec Gendux
  346. EU/3/11/873 - orphan designation for treatment of epidermolysis bullosa
  347. FDA Recommends Health Care Facilities Stop Using Custom Ultrasonics’ System 83 Plus…
  348. cdsco-efruxifermin-efxEFRUXIFERMIN (EFX)
  349. Drug Alert list for month of April 2022 (Revised)
  350. EU/3/05/293 - orphan designation for treatment of acute lymphoblastic leukaemia
  351. Documents from advisory groups on clinical-trial data
  352. Strengthening of Medical Products Safety Surveillance System in North Eastern States of…
  353. EMEA-001363-PIP01-12-M01 - paediatric investigation plan
  354. EU/3/20/2355 - orphan designation for treatment of pancreatic cancer
  355. EMEA-002658-PIP01-19 - paediatric investigation plan
  356. Matthew B. Weinger: Why Are Our Infusion Pumps Not Smarter or Safer?
  357. Committee for Advanced Therapies (CAT): 12-13 December 2013
  358. 21 CFR 862.1790: Uroporphyrin test system.
  359. Paediatric Committee (PDCO): 11-13 September 2013
  360. Warning statements for labels and leaflets of certain medicines
  361. Flupirtine-containing medicines - referral
  362. ema-impridaImprida
  363. Submission and processing of application for Registration Certificate and import License…
  364. Appointment of First Appellate Authority & CPIO for the purpose of RTI (Technical) matters
  365. ema-avziviAvzivi
  366. EU/3/11/863 - orphan designation for treatment of haemophilia B
  367. EMEA-002493-PIP01-18-M05 - paediatric investigation plan
  368. Pharmacovigilance responsibilities of medicine sponsors
  369. PSUSA/00000919/202302 - periodic safety update report single assessment
  370. NexGard Combo - opinion on variation to marketing authorisation
  371. The European Medicines Agency and the Netherlands agree on Seat Agreement
  372. Committee for Medicinal Products for Veterinary Use holds 200th meeting
  373. Data requirements for swine influenza vaccines against pandemic (H1N1) 2009 influenza…
  374. Worksharing of variations (veterinary medicines)
  375. EU/3/07/452 - orphan designation for treatment of gastric carcinoid
  376. ema-glucomed-referralGlucomed - referral
  377. ema-staquisStaquis
  378. EU/3/15/1443 - orphan designation for treatment of glioma
  379. Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA…
  380. PSUSA/00009057/201501 - periodic safety update report single assessment
  381. AAMI News, July 2022, Vol.57, No.7
  382. Considerations for Non-clinical Studies of Combination Prescription Drugs with Similar…
  383. Datopotamab Deruxtecan (Dato-DXd)
  384. William Hyman: Updated, but Not Up To Date at the FDA
  385. ema-clomicalmClomicalm
  386. Public Statement: European Medicines Agency starts review of the safety of epoetins
  387. Committee for medicinal products for veterinary use: Meeting of 14 to 15 June 2005
  388. Praluent recommended for approval to lower cholesterol
  389. Committee for Medicinal Products for Human Use (CHMP): 9-12 November 2020
  390. 21 CFR 862.1625: Prolactin (lactogen) test system.
  391. Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 March…
  392. ema-aldaraAldara
  393. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
  394. Change management for the EudraVigilance system
  395. ema-workshop-on-biosimilarsWorkshop on biosimilars
  396. Pre-Approval Inspections: New Animal Drug Applications (NADA); Abbreviated New Animal Drug…
  397. Metalyse - opinion on variation to marketing authorisation
  398. Avinash Konkani: Applying User Experience and Design Thinking to Medical Device Design
  399. EU/3/15/1536 - orphan designation for treatment of cystic fibrosis
  400. CattleMarker IBR Inactivated - referral
  401. EMA encourages companies to submit type I variations for 2023 in November 2023
  402. Points to Consider for Ensuring the Reliability in Utilization of Registry Data for…
  403. ema-dapagliflozin-viatrisDapagliflozin Viatris
  404. 21 CFR 886.5200: Eyelid thermal pulsation system.
  405. Grain Product Manufacturers
  406. ema-ertapenem-hospiraErtapenem Hospira
  407. Team-NB-Statment on Covid 19 – 20200312
  408. Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Chlorthalidone IP Film…
  409. EU/3/13/1108 - orphan designation for treatment of systemic sclerosis
  410. 21 CFR 884.5435: Unscented menstrual pad.
  411. EU/3/23/2803 - orphan designation for treatment of myelofibrosis
  412. PSUSA/00001500/202108 - periodic safety update report single assessment
  413. 21 CFR 876.1310: Magnetically maneuvered capsule endoscopy system.
  414. Conduct of efficacy studies for intramammary products for use in cattle - Scientific…
  415. Flow of Complaints Handling
  416. Drug Alert for the Month of December 2023
  417. 21 CFR 866.6080: Next generation sequencing based tumor profiling test.
  418. Notice: Health Products and Food Branch Inspectorate - Establishment Licensing - Important…
  419. FDA to Shift Focus to International Standard, Replacing Quality System Regulation
  420. FDA Drug Safety Communication: Medication errors from swallowing topical Benadryl Extra…
  421. Tacrolimus granules product-specific bioequivalence guidance
  422. Leflunomide Zentiva (previously Leflunomide Winthrop)
  423. EMEA-003236-PIP01-22 - paediatric investigation plan
  424. EU/3/19/2206 - orphan designation for treatment of Alexander disease
  425. EMEA-001759-PIP01-15 - paediatric investigation plan
  426. ema-desloratadine-actavisDesloratadine Actavis
  427. EMEA-002486-PIP04-21 - paediatric investigation plan
  428. Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 September 2024
  429. 21 CFR 1.1385: What process will FDA follow when adopting modified requirements or…
  430. 21 CFR 17.21: Prehearing conferences.
  431. EMEA-002137-PIP01-17 - paediatric investigation plan
  432. Drug Alert for the Month of May – 2022 Revised
  433. EU/3/23/2828 - orphan designation for treatment of transthyretin-mediated amyloidosis
  434. Questions and answers: Orphan-designation application
  435. PSUSA/00003043/202008 - periodic safety update report single assessment
  436. Matricariae flos - herbal medicinal product
  437. EMA: working for every patient in Europe
  438. European Medicines Agency finalises update to diabetes guideline
  439. Annual performance Appraisal Reports (ACR group C)(Related to Employees)
  440. EU/3/21/2551 - orphan designation for treatment of frontotemporal dementia
  441. 21 CFR 880.6820: Medical disposable scissors.
  442. With New Wi-Fi on the Horizon, Is It Time for New Devices?
  443. Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca
  444. Announcement of the “Implementation details and transition periods of the Western…
  445. Submissions received: Proposal for clarifying the regulation of residual-activity claims…
  446. PSUSA/00001786/202211 - periodic safety update report single assessment
  447. EU/3/16/1742 - orphan designation for treatment of Smith-Magenis syndrome
  448. ema-efientEfient
  449. EMEA-002754-PIP01-19 - paediatric investigation plan
  450. Scheduling handbook: Guidance for amending the Poisons Standard
  451. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-5…
  452. cdsco-sugam-user-manualSugam User Manual
  453. Development of new medicinal products for the treatment of smoking - Scientific guideline
  454. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 20…
  455. 21 CFR 876.4590: Interlocking urethral sound.
  456. April 24.04.2014 G.S.R 292 (E)
  457. cdsco-imlunestrantImlunestrant
  458. EU/3/19/2176 - orphan designation for treatment of haemophilia A
  459. Seeking International Harmonization, FDA’s CDRH Issues New Strategic Plan
  460. Lumateperone Capsules 42mg
  461. ema-kymriahKymriah
  462. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2012
  463. cdsco-july-14-2014-gsr-502-eJuly 14 2014 GSR 502(E)
  464. PSUSA/00000605/202212 - periodic safety update report single assessment
  465. Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 October 2017
  466. Ensifentrine Inhalation Suspension 3mg (3 mg/2.5ml)
  467. Regulatory research dementia workshop conclusions
  468. PSUSA/00002310/201808 - periodic safety update report single assessment
  469. August 1, 2023: Meeting of the Medical Imaging Drugs Advisory Committee Meeting…
  470. NMPA Issues Guidance for the Preservation of Essential Documents for Drug Clinical Trials
  471. (Doc Version - 140 K)
  472. FAQ (3DP Medical Devices) 2021
  473. Testosterone - paediatric investigation plan
  474. nbcg-team-nb-member-list-51TEAM-NB-Member-List-51
  475. cfr-21-cfr-890-1-scope21 CFR 890.1: Scope.
  476. EU/3/24/2902 - orphan designation for treatment of mesothelioma
  477. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4…
  478. EU/3/15/1488 - orphan designation for treatment of ovarian cancer
  479. Savolitinib plus Durvalumab
  480. Regulations for Medical Device Recalls
  481. PSUSA/00000527/202204 - periodic safety update report single assessment
  482. CMDh endorses suspension of methadone oral solutions containing high molecular weight…
  483. Application requirements for new substances in listed medicines
  484. PSUSA/00002643/201808 - periodic safety update report single assessment
  485. cfr-21-cfr-21-1-scope21 CFR 21.1: Scope.
  486. Appendix 11B Sample Letter of Access for DMF
  487. PSUSA/00000170/201801 - periodic safety update report single assessment
  488. Warner Chilcott UK Ltd withdraws its application for an extension of indication for…
  489. Recommendation_Vigilance_after NB-Med_2007-04
  490. Committee for veterinary medicinal products: Meeting of 14 to 16 January 2003
  491. EU/3/12/983 - orphan designation for treatment of acute liver failure
  492. 21 CFR 73.530: Spirulina extract.
  493. Introducing the AAMI Fellows Class of 2021
  494. EU/3/01/055 - orphan designation for treatment of indolent non-Hodgkin's lymphoma
  495. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8…
  496. 21 CFR 880.6992: Medical washer-disinfector.
  497. Coordination of pharmacovigilance inspections
  498. New action plan to foster development of advanced therapies
  499. Notice regarding Online application for Human Vaccines on Sugam
  500. Colourings used in medicines for topical and oral use
  501. PSUSA/00002105/201502 - periodic safety update report single assessment
  502. cdsco-prolectin-i-injectionProlectin-I Injection
  503. 21 CFR 882.4840: Manual rongeur.
  504. European Medicines Agency finalises review of recent published data on cardiovascular…
  505. Committee for Advanced Therapies (CAT): 14-16 February 2024
  506. cfr-21-cfr-73-2087-carmine21 CFR 73.2087: Carmine.
  507. EMEA-003268-PIP01-22 - paediatric investigation plan
  508. EU/3/16/1693 - orphan designation for treatment of retinitis pigmentosa
  509. Meeting of the EMEA working party on herbal medicinal products 13 - 14 March 2001
  510. EU/3/12/1081 - orphan designation for treatment of very-long-chain…
  511. cdsco-varespladib-methylVarespladib-Methyl
  512. Metformin product-specific bioequivalence guidance
  513. AAMI News, November 2021, Vol.56, No.11
  514. European Medicines Agency finalises guidance on medicines containing monoclonal antibodies
  515. Publice Notice from veterinary Division
  516. EMEA-000071-PIP01-07 - paediatric investigation plan
  517. PSUSA/00010190/201512 - periodic safety update report single assessment
  518. Gendux Molecular Limited withdraws its marketing authorisation application for Contusugene…
  519. EMEA-001312-PIP01-12 - paediatric investigation plan
  520. Viral safety of plasma-derived medicinal products with respect to hepatitis E virus…
  521. PSUSA/00000775/201801 - periodic safety update report single assessment
  522. ema-voriconazole-accordVoriconazole Accord
  523. Polmacoxib Capsules 2 mg
  524. EU/3/21/2552 - orphan designation for treatment of cystic fibrosis
  525. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April…
  526. WHO Medical Device Leader Cites Global HTM Challenges, Opportunities
  527. ema-ytracisYtracis
  528. Special Access Scheme and Authorised Prescriber Pathway: Guidance for Sponsors
  529. ema-fampyraFampyra
  530. Committee for Advanced Therapies (CAT) meeting with interested parties
  531. EU/3/21/2448 - orphan designation for treatment of pre-eclampsia
  532. EU/3/07/513 - orphan designation for treatment of tuberculosis
  533. Notice regarding on "online Process for Grant of NOC for clinical Trials"
  534. cdsco-remibrutinib-lou064remibrutinib LOU064
  535. EMEA-002249-PIP01-17 - paediatric investigation plan
  536. ema-bonqatBonqat
  537. cdsco-eravacyclineEravacycline
  538. PSUSA/00002411/201703 - periodic safety update report single assessment
  539. EMEA-000555-PIP01-09-M06 - paediatric investigation plan
  540. 21 CFR 862.1050: Alkaline phosphatase or isoenzymes test system.
  541. ema-breyanziBreyanzi
  542. ema-unisol-referralUnisol - referral
  543. 2013.11.07_S.O. 3395(E)_Notification for Appointment of Drugs Inspectors
  544. EMEA-003055-PIP02-23 - paediatric investigation plan
  545. EMEA-000399-PIP01-08 - paediatric investigation plan
  546. PSUSA/00010291/202306 - periodic safety update report single assessment
  547. EMEA-001369-PIP01-12 - paediatric investigation plan
  548. Committee for medicinal products for veterinary use: Meeting of 11-12 January 2005
  549. New medicine for multiple myeloma patients with limited treatment options
  550. Celgene Europe Limited withdraws its marketing authorisation application for Lenalidomide…
  551. EU/3/06/426 - orphan designation for treatment of primary malignant bone tumours
  552. 21 CFR 862.3380: Ethosuximide test system.
  553. ICH Q1B Photostability testing of new active substances and medicinal products…
  554. Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication
  555. EMEA-003082-PIP01-21 - paediatric investigation plan
  556. The use of Artificial Intelligence (AI) in the medicinal product lifecycle
  557. European Medicines Agency to grant fee waivers to applications for bluetongue vaccines
  558. EMEA-002375-PIP01-18 - paediatric investigation plan
  559. PSUSA/00002911/201610 - periodic safety update report single assessment
  560. Empagliflozin + Metoprolol Succinate IP Eq. to Metoprolol Tartrate IP (10mg + 23.75mg eq…
  561. Committee for Proprietary Medicinal Products (CPMP): meeting of 24 to 26 June 2001
  562. EMEA-000362-PIP01-08-M04 - paediatric investigation plan
  563. EMEA-001581-PIP01-13-M03 - paediatric investigation plan
  564. ICH Q1E Evaluation of stability data - Scientific guideline
  565. PSUSA/00010488/202005 - periodic safety update report single assessment
  566. 2016 annual workshop of the European network of paediatric research (Enpr-EMA) at the…
  567. Wyeth Europa Ltd withdraws its marketing authorisation application for Ellefore
  568. Assessing Use-Related Risk: FDA’s New Draft Guidance on URRA
  569. cdsco-s-g-3793-eS.G 3793(E)
  570. EU/3/18/1986 - orphan designation for treatment of activated phosphoinositide 3-kinase…
  571. PSUSA/00002320/202304v - periodic safety update report single assessment
  572. European Medicines Agency recommends withdrawal of the marketing authorisations for…
  573. Committee for medicinal products for veterinary use: Meeting of 12-14 May 2009
  574. Inspection of Tissue Establishments
  575. EU/3/16/1624 - orphan designation for treatment of chronic lymphocytic leukaemia / small…
  576. Consideration in the development of drugs for hypertrophic cardiomyopathy (Early…
  577. cdsco-lnp023-iptacopanLNP023 (Iptacopan)
  578. EU/3/21/2475 - orphan designation for treatment of achondroplasia
  579. Making the Grade—Advice for Passing the CBET Exam
  580. 21 CFR 1.227: What definitions apply to this subpart?
  581. Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2018 (SI…
  582. European Medicines Agency opens public discussion on need for active control in clinical…
  583. First medicine recommended for approval for hidradenitis suppurativa
  584. EU/3/16/1665 - orphan designation for treatment of retinitis pigmentosa caused by…
  585. PSUSA/00001825/201711 - periodic safety update report single assessment
  586. cdsco-nthe-drugs-rules-1945nTHE DRUGS RULES 1945
  587. European Medicines Agency and Swissmedic extend confidentiality arrangement
  588. ISO 15223-1 and the Role of Symbols in Communicating Critical Information
  589. ema-evrenzoEvrenzo
  590. PSUSA/00010386/201610 - periodic safety update report single assessment
  591. mhra-mhra-graduate-schemeMHRA Graduate Scheme
  592. ema-bavencioBavencio
  593. NMPA issued the Announcement on Implementing Electronic Application of Medical Device…
  594. 21 CFR 1.693: How do I request a regulatory hearing on a revocation of recognition or…
  595. PSUSA/00001860/201601 - periodic safety update report single assessment
  596. GCP Inspection Checklist16
  597. UPDATED PUBLIC PARTICIPATION INFORMATION: January 24, 2023: Antimicrobial Drugs Advisory…
  598. Eplivanserin hemifumarate - paediatric investigation plan
  599. 2016 European Union Good Clinical Practice Inspectors Working Group workshop
  600. Committee for Advanced Therapies (CAT): 30-31 October 2023
  601. 21 CFR 868.1930: Stethoscope head.
  602. cdsco-order-skin-aestheticsOrder (Skin Aesthetics)
  603. THE SUBJECT EXPERT COMMITTEES GUIDANCE DOCUMENT
  604. Health Product Complaint Process - Questions and Answers
  605. EU/3/10/760 - orphan designation for treatment of ovarian cancer
  606. 21 CFR 892.1000: Magnetic resonance diagnostic device.
  607. 20th anniversary conference highlights
  608. EMA’s safety committee elects new chair
  609. Guidance Document: Safety and Effectiveness Requirements for Contact Lens Disinfectants…
  610. PSUSA/00010381/202004 - periodic safety update report single assessment
  611. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  612. Classification of Medical Device Pertaining to Dental Under the provision of Medical…
  613. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - September 2017
  614. Details of Importers whose permissions have been suspended / cancelled 2021
  615. ema-phelinunPhelinun
  616. ema-advexinAdvexin
  617. 21 CFR 82.1254: D&C Orange No. 4.
  618. Committee for Advanced Therapies (CAT): 21-22 January 2016
  619. PSUSA/00010572/201706 - periodic safety update report single assessment
  620. Paediatric Committee (PDCO): 8-10 September 2010
  621. ema-rotateqRotaTeq
  622. EMEA-001771-PIP01-15 - paediatric investigation plan
  623. EU/3/16/1628 - orphan designation for treatment of oesophageal cancer
  624. ema-gegantGeGant
  625. Variations not already listed (veterinary medicines)
  626. Tenth meeting of the industry stakeholder platform on the operation of the centralised…
  627. Updated advice on use of high-dose ibuprofen
  628. Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication
  629. ema-sibutramine-referralSibutramine - referral
  630. Updated list of laboratories for conducting Performance evaluation of IVD reagents/kits
  631. Solani dulcamarae stipites - herbal medicinal product
  632. ema-celecoxib-referralCelecoxib - referral
  633. PSUSA/00001346/201710 - periodic safety update report single assessment
  634. PSUSA/00000779/202112 - periodic safety update report single assessment
  635. EU/3/18/2100 - orphan designation for treatment of focal segmental glomerulosclerosis
  636. Elocalcitol - paediatric investigation plan
  637. PSUSA/00001507/202108 - periodic safety update report single assessment
  638. 21 CFR 866.5900: Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation…
  639. Diphtheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents IP
  640. Emma Fauss: Leverage Your Device Data for Advanced Event Detection
  641. Field Submission of Articles
  642. 21 CFR 886.1395: Diagnostic Hruby fundus lens.
  643. EU/3/07/463 - orphan designation for treatment of cardiogenic shock
  644. PSUSA/00002203/201804 - periodic safety update report single assessment
  645. Docetaxel Teva Generics - referral
  646. Metamizole containing medicinal products - referral
  647. Brinzolamide IP + Timolol Maleate IP eq. to Timolol + Potassium Sorbate IP (as…
  648. 21 CFR 892.1680: Stationary x-ray system.
  649. cdsco-selpercatinibSelpercatinib
  650. 21 CFR 870.5225: External counter-pulsating device.
  651. 2026.01.20_G.S.R. 46(E)_Notification about changes to requirements of Test license under…
  652. ema-maci-referralMaci - referral
  653. PSUSA/00000794/201809 - periodic safety update report single assessment
  654. ema-polivyPolivy
  655. ema-open-lettersOpen letters
  656. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - October 2015
  657. EMEA-002304-PIP01-17 - paediatric investigation plan
  658. Clinical Trials Information System Webinar: Second Year of Transition
  659. EU/3/09/663 - orphan designation for treatment of Duchenne muscular dystrophy
  660. PSUSA/00009271/201803 - periodic safety update report single assessment
  661. From Firefighting to Forensics: Preparing for Updates to 405(d) Health Industry…
  662. 21 CFR 73.1400: Pyrophyllite.
  663. Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/…
  664. EMEA-002431-PIP02-21 - paediatric investigation plan
  665. PSUSA/00003063/202109 - periodic safety update report single assessment
  666. ema-celsentriCelsentri
  667. EU/3/03/150 - orphan designation for treatment of cutaneous T-cell lymphoma
  668. EMA workshop with European Union pharmaceutical industry associations on the…
  669. EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations…
  670. March 20, 2012 (GSR 228(E))
  671. EMA regular press briefing on COVID-19 and monkeypox
  672. EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo
  673. Non-pharmaceutical products
  674. Public Notice regarding Draft CDSCO Guidance for Industry on Pharmacovigilance…
  675. Preparation of a Quality System Dossier (GUIDE-MQA-019)
  676. EMEA-002827-PIP01-20-M01 - paediatric investigation plan
  677. EMEA-002349-PIP03-20 - paediatric investigation plan
  678. Concept paper on a guideline for allergen products development in moderate to low-sized…
  679. ema-uman-big-referralUman Big - referral
  680. Sixth industry stakeholder platform on research and development support
  681. 21 CFR 880.6315: Remote Medication Management System.
  682. Pioglitazone ratiopharm GmbH
  683. POSTPONED: November 18, 2022 Joint Meeting of the Nonprescription Drugs Advisory Committee…
  684. EMEA-001621-PIP01-14 - paediatric investigation plan
  685. Orthosiphonis folium - herbal medicinal product
  686. 24th meeting of the Committee for Orphan Medicinal Products
  687. EU/3/15/1558 - orphan designation for treatment for Ebola virus disease
  688. 2023.12.28_DR_Final G.S.R. 922(E)_Notification of Schedule M of Drugs Rules,1945.
  689. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 November 2018
  690. 21 CFR 864.8185: Calibrator for red cell and white cell counting.
  691. 21 CFR 801.18: Format of dates provided on a medical device label.
  692. EMEA-002069-PIP02-17 - paediatric investigation plan
  693. PSUSA/00001897/202308 - periodic safety update report single assessment
  694. ema-cavoleyCavoley
  695. FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic…
  696. Rick Hampton: Why You Should Care About the Middle Class Tax Relief and Job Creation Act…
  697. Non-clinical and clinical evaluation of antiviral medicinal products and monoclonal…
  698. 2012 European Union Good Clinical Practice Inspectors Working Group workshop
  699. Tyverb - withdrawal of application for variation to marketing authorisation
  700. International Clinical Trials' Day
  701. Notice with respect to Antimicrobial resistance dated 16.01.2017
  702. Golcadomide (BMS- 986369/CC -99282)
  703. European Medicines Agency closed 9 May 2014
  704. 21 CFR 890.3490: Truncal orthosis.
  705. ema-pritorplusPritorPlus
  706. PSUSA/00001184/201412 - periodic safety update report single assessment
  707. EMEA-000608-PIP01-09 - paediatric investigation plan
  708. 21 CFR 870.2120: Extravascular blood flow probe.
  709. EMEA-002354-PIP02-18-M01 - paediatric investigation plan
  710. Sodium Salicylate - referral
  711. EU/3/23/2884 - orphan designation for treatment of Rett syndrome
  712. 21 CFR 1.242: What does assignment of a registration number mean?
  713. International regulators working together to enhance collaboration on COVID-19…
  714. Notice for filling of application for Clinical Trial, Marketing Authorization…
  715. European Medicines Agency recommends cautious use of protopic/protopy and elidel
  716. PSUSA/00001164/201709 - periodic safety update report single assessment
  717. 21 CFR 803.16: When I submit a report, does the information in my report constitute an…
  718. Fifth meeting of the EMEA Human Scientific Committees' Working Party with with Patients'…
  719. GN-14-R2 Guidance on the Risk Classification of In Vitro Diagnostic MD [ARCHIVED on 24 Jul…
  720. PSUSA/00010496/201706 - periodic safety update report single assessment
  721. Clinical evaluation of new vaccines - Scientific guideline
  722. Drug Alert list for month of March 2021
  723. ema-holoclarHoloclar
  724. EMEA launches action plan for improvements for human medicines
  725. ema-zegalogueZegalogue
  726. EU/3/16/1615 - orphan designation for treatment of Ebola virus disease
  727. European Medicines Agency publishes report on sales of veterinary antimicrobial agents in…
  728. 21 CFR 878.4800: Manual surgical instrument for general use.
  729. EU/3/15/1561 - orphan designation for treatment of aniridia
  730. EMEA-002142-PIP01-17 - paediatric investigation plan
  731. Absinthii herba - herbal medicinal product
  732. Use of third- and fourth-generation cephalosporins in food-producing animals in the…
  733. PSUSA/00002669/201812 - periodic safety update report single assessment
  734. ema-osurniaOsurnia
  735. FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain…
  736. 21 CFR 820.250: Statistical techniques.
  737. 21 CFR 890.3500: External assembled lower limb prosthesis.
  738. Committee for veterinary medicinal products: 50th meeting
  739. Use of herbal medicinal products containing estragole - Scientific guideline
  740. Regulations Governing Commission of Medical Devices Management and Accreditation of…
  741. 21 CFR 878.4022: Hydrogel wound dressing and burn dressing.
  742. 21 CFR 872.4200: Dental handpiece and accessories.
  743. ema-loraxin-referralLoraxin - referral
  744. 21 CFR 807.92: Content and format of a 510(k) summary.
  745. cdsco-isth0036ISTH0036
  746. Dydrogesterone Extended Release Tablet 20 mg
  747. Safeguards and consent requirements in vulnerable trial participants
  748. Reyataz - opinion on variation to marketing authorisation
  749. EudraVigilance information day
  750. Belantamab Mafodotin (GSK2857916)
  751. Guide to Fees for Human Products
  752. CHMP meets to discuss Avandia and Pandemrix
  753. Considerations for the Utilization of Master Protocol Trials in Drug Development
  754. Joint DIA - EMEA - CMD(h) workshop on user testing
  755. FDA Expands Its Portfolio of Regulatory Science Tools to Accelerate Innovation
  756. ema-proquadProQuad
  757. EU/3/22/2699 - orphan designation for treatment of glioma
  758. EMEA-000958-PIP01-10 - paediatric investigation plan
  759. Appendix IV of the guideline on the investigation on bioequivalence: presentation of…
  760. Stability testing of existing active substances and related finished products - Scientific…
  761. cdsco-aur-101AUR-101
  762. 21 CFR 878.3540: Silicone gel-filled breast prosthesis.
  763. ‘Regulatory science to 2025’: live broadcast of post-consultation workshop
  764. EU/3/14/1395 - orphan designation for treatment of acute myeloid leukaemia
  765. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  766. EMEA-002291-PIP01-17 - paediatric investigation plan
  767. Baytril injectable - referral
  768. 21 CFR 868.1890: Predictive pulmonary-function value calculator.
  769. 21 CFR 868.5790: Tracheal tube stylet.
  770. ema-draxxinDraxxin
  771. Public Statement on HerceptinN(Trastuzumab): New Pharmacokinetic Data
  772. Milvexian, an Oral Factor XIa Inhibitor
  773. PSUSA/00010396/202004 - periodic safety update report single assessment
  774. 21 CFR 14.10: Applicability to Congress.
  775. Fourth Meeting of the Management Board of the European Agency for the Evaluation of…
  776. Is AI Helping or Harming Health Equity?
  777. Addendum 02 to FAQ on Medical Devices Rules 2017
  778. EMA urgently reviewing multiple sclerosis medicine Zinbryta following cases of…
  779. PSUSA/00001366/201709 - periodic safety update report single assessment
  780. COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to…
  781. Congratulations to the 2023 AAMI Award Winners!
  782. EMEA-002387-PIP02-21 - paediatric investigation plan
  783. Zydelig - withdrawal of application for variation to marketing authorisation
  784. March 30, 2012 (GSR 270(E)
  785. Office Memorandum on COVID-19
  786. ema-orphan-incentivesOrphan incentives
  787. New recommendations for terlipressin-containing medicines in the treatment of hepatorenal…
  788. MHRA Portal: register to submit forms
  789. Handling of Performance Evaluation Tests of Diagnostic Medical Devices Using Existing…
  790. COVID Dashboard Facilitates Improved Visibility and Use of Respiratory Equipment for…
  791. ema-coaprovelCoAprovel
  792. Revlimid - withdrawal of application for variation to marketing authorisation
  793. PSUSA/00010461/201809 - periodic safety update report single assessment
  794. Good Manufacturing Practices
  795. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - July 2018
  796. Brain diseases in the elderly
  797. EU/3/10/764 - orphan designation for treatment of tuberous sclerosis
  798. 21 CFR 864.5620: Automated hemoglobin system.
  799. PSUSA/00010790/202108 - periodic safety update report single assessment
  800. Pubic Notice Notice regarding Public Consulatation Regarding Regulation of Sale of Drugs…
  801. Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication
  802. Drug Safety Update: monthly PDF newsletter: Drug Safety Update August 2021
  803. 21 CFR 888.3075: Posterior cervical screw system.
  804. ema-bropair-spiromaxBroPair Spiromax
  805. EMEA-003278-PIP01-22 - paediatric investigation plan
  806. PSUSA/00010353/201705 - periodic safety update report single assessment
  807. EU/3/19/2191 - orphan designation for treatment of pancreatic cancer
  808. Joint EMA-ECDC press briefing on current state of respiratory diseases and treatments in…
  809. 2019.03.20 Final G.S.R. 231(E) Date of implementation of G.S.R.408(E) dated 26.04.2018
  810. Committee for veterinary medicinal products: 55th meeting
  811. FDA Issues Draft Guidance on Computer Software Assurance for Production and Quality System…
  812. June 3-4, 2021: Neurological Devices Panel of the Medical Devices Advisory Committee…
  813. FDA Updated Communication on Use of Jet Injectors with Inactivated Influenza Vaccines
  814. Post-authorisation measures (recommendations, conditions and specific obligations)…
  815. 21 CFR 882.5320: Preformed alterable cranioplasty plate.
  816. PSUSA/00000582/201908 - periodic safety update report single assessment
  817. New tracking tool for EMA's relocation to Amsterdam
  818. Eight Nitrosamine Implementation Oversight Group (NIOG) meeting
  819. EMEA-002645-PIP02-20 - paediatric investigation plan
  820. 21 CFR 58.81: Standard operating procedures.
  821. The number of tests required to control for complete inactivation in inactivated vaccines
  822. ema-prevenarPrevenar
  823. 21 CFR 862.3350: Diphenylhydantoin test system.
  824. ema-vevizyeVevizye
  825. Member News: ONE on ONE Steve Yelton
  826. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June…
  827. 2024.03.18_DR_G.S.R. 216(E)_Omission of Glyceryl Trinitrate and Isosorbide Dinitrate from…
  828. AAMI News, September 2022, Vol.57, No.9
  829. EMEA-001231-PIP02-13-M10 - paediatric investigation plan
  830. ema-sebivoSebivo
  831. Atropine Sulphate Ophthalmic Solution 0.05% w/v0.05 % w/v Ophthalmic Solution
  832. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27…
  833. Application Form for Compensation-DePuy J &J ASR Hip Implant
  834. PIC/S Guidelines on Excipient GMP Risk Assessment
  835. Public Notice regarding Meeting of DTAB sub Committee w.ef 05.06.2018 to 22.06.2018 in the…
  836. 21 CFR 26.7: Participation in the equivalence assessment and determination.
  837. Pathways for supply of biologicals
  838. Sitagliptin phosphate monohydrate, metformin hydrochloride - paediatric investigation plan
  839. Committee for Medicinal Products for Human Use (CHMP): 23-26 July 2018
  840. Maximum Residue Limits Q&A: Introduction
  841. Launch of PRIME - Paving the way for promising medicines for patients
  842. 21 CFR 866.3630: Serratia spp. serological reagents.
  843. 21 CFR 878.4950: Manual operating table and accessories and manual operating chair and…
  844. EU/3/18/2116 - orphan designation for treatment of cystic fibrosis
  845. GN-07-R2.2 Guidance on Complaint Handling(2022 Nov)_PUB
  846. ema-chanaxinChanaxin
  847. PSUSA/00001792/201905 - periodic safety update report single assessment
  848. Annual Rate Contract for Hiring taxies 3 Last Date( 27 Jul 2012 )
  849. 21 CFR 866.3830: Treponema pallidum treponemal test reagents.
  850. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - June 2019
  851. 21 CFR 14.33: Compilation of materials for members of an advisory committee.
  852. Just Published! Acute Dialysis Survey Readiness Handbook: Second Edition
  853. Redistribution of UK's portfolio of centrally authorised products
  854. Principles for the Evaluation of Vaccines Against the Novel Coronavirus SARS-CoV-2
  855. EMEA-000865-PIP01-10 - paediatric investigation plan
  856. Regulatory requirements for the development of medicinal products for Acute Kidney Injury…
  857. Avinash Konkani: The Role of Industrial Engineers in Healthcare
  858. Reporting adverse incidents: biological and mechanical surgical heart valves
  859. Herbal medicines granted a traditional herbal registration (THR): Herbal medicines granted…
  860. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14…
  861. Dienogest - paediatric investigation plan
  862. Data integrity: key to public health protection
  863. Template for a European Union herbal monograph
  864. ema-purevax-rabiesPurevax Rabies
  865. European Medicines Agency closes PIM project
  866. Drug Repackers and Relabelers (PDF - 182KB)
  867. 21 CFR 74.1708: D&C Yellow No. 8.
  868. 21 CFR 822.15: How long must I conduct postmarket surveillance of my device?
  869. EU/3/13/1165 - orphan designation for treatment of N-acetylglutamate synthetase (NAGS)…
  870. ema-sarclisaSarclisa
  871. PSUSA/00001711/201707 - periodic safety update report single assessment
  872. Progress with EU-US mutual recognition agreement for inspections for veterinary medicines
  873. African Medicines Agency (African Union)
  874. 21 CFR 58.202: Grounds for disqualification.
  875. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 5-7…
  876. EU/3/05/306 - orphan designation for treatment of mastocytosis
  877. EMEA-000309-PIP02-14 - paediatric investigation plan
  878. COVID-19 Rapid antigen tests
  879. Paediatric Committee (PDCO): 18-21 April 2017
  880. Teneligliptin Hydrobromide hydrate eq. to Teneligliptin + Dapagliflozin tablets (Phase…
  881. 32nd meeting of the Committee for Orphan Medicinal Products
  882. Committee for Orphan Medicinal Products (COMP): 4-5 September 2012
  883. EU/3/24/2893 - orphan designation for treatment of gastric cancer
  884. Committee for Advanced Therapies (CAT): 18-19 April 2013
  885. EU/3/12/1060 - orphan designation for treatment of systemic light chain amyloidosis
  886. Quality management system audits and certification guidance
  887. EU/3/07/504 - orphan designation for treatment of glioma
  888. EMEA-001222-PIP01-11 - paediatric investigation plan
  889. Clinical development of medicinal products for the treatment and prevention of bipolar…
  890. Paul Kelley: A Bittersweet Goodbye
  891. Committee for Advanced Therapies (CAT): 11-13 September 2019
  892. European Medicines Agency applies greater fee-reduction rates for orphan medicines in 2014
  893. ema-inomaxINOmax
  894. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  895. P0001.002: Functional Statement
  896. The PROTECT project on pharmacovigilance achieves key objectives
  897. 21 CFR 870.2675: Oscillometer.
  898. EU/3/12/1014 - orphan designation for treatment of keratinopathic ichthyosis
  899. Marketing and cessation notification: Regulatory and procedural guidance
  900. Launching of National Single Window System (NSWS) Portal
  901. Clearance of Import and Export Consignments at Ports/Airports/Others Points
  902. Fenspiride containing medicinal products - referral
  903. AAMI Honors 2020 Award and Scholarship Winners
  904. EU actions to support availability of medicines during COVID-19 pandemic – update #7
  905. EMEA-000876-PIP05-15-M05 - paediatric investigation plan
  906. EU/3/15/1527 - orphan designation for treatment of amyotrophic lateral sclerosis
  907. How the FDA Uses Science to Speed Medical Device Innovation and Support Entrepreneurship…
  908. PSUSA/00000051/201510 - periodic safety update report single assessment
  909. Committee for Orphan Medicinal Products: December 2003 meeting
  910. PSUSA/00000262/201511 - periodic safety update report single assessment
  911. Clinical investigation of medicinal products for the treatment of gout - Scientific…
  912. ema-eurneffyEurneffy
  913. AAMI News, October 2021, Vol.56, No.10
  914. 21 CFR 806.10: Reports of corrections and removals.
  915. EMEA-002978-PIP01-21 - paediatric investigation plan
  916. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19…
  917. cdsco-diclofenac-gelDiclofenac Gel
  918. PSUSA/00003089/201603 - periodic safety update report single assessment
  919. TEAM-NB-22Anniversary-PressRelease-20230420
  920. Tenth Nitrosamine Implementation Oversight Group (NIOG) meeting
  921. 21 CFR 882.1350: Needle electrode.
  922. ema-cat-membersCAT members
  923. Guidance for IVD sponsors - a roadmap to market
  924. EMEA-002006-PIP01-16 - paediatric investigation plan
  925. AS P0014.003: Special Remote Assessment
  926. ema-two-years-of-primeTwo years of PRIME
  927. EMA recommends treatment for rare cancer in children
  928. ema-natparNatpar
  929. eSubmission Gateway release II and eSubmission web client now live for all applications…
  930. cdsco-masitinibMasitinib
  931. EMEA announces composition of its scientific committees
  932. PSUSA/00001233/202009 - periodic safety update report single assessment
  933. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 October 2016
  934. Breast implants: things to consider
  935. EMEA-002520-PIP01-18 - paediatric investigation plan
  936. EMEA-003218-PIP01-22 - paediatric investigation plan
  937. Mepolizumab Powder for Solution for Injection
  938. EU/3/24/2916 - orphan designation for treatment of tuberculosis
  939. Electronic issue of blood components
  940. Bringing Global Communities Together at HIMSS23
  941. 2012 annual report on EudraVigilance published
  942. ema-finleeFinlee
  943. PSUSA/00001009/201511 - periodic safety update report single assessment
  944. ema-leflunomide-tevaLeflunomide Teva
  945. William Hyman: Food for Thought in an FDA Warning Letter on Reprocessing
  946. Paediatric Committee (PDCO): 7-10 November 2017
  947. Committee for Medicinal Products for Human Use (CHMP): 14-17 January 2013
  948. EU/3/12/979 - orphan designation for treatment of calciphylaxis
  949. 21 CFR 888.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  950. European Medicines Agency simplifies SME assignment process
  951. ema-tritanrix-hbTritanrix HB
  952. ema-innovax-nd-ibdInnovax-ND-IBD
  953. Committee for Medicinal Products for Human Use (CHMP): 14-17 March 2011
  954. EMEA-001799-PIP03-19 - paediatric investigation plan
  955. European Medicines Agency concludes that benefit-risk balance of Revlimid remains positive
  956. ema-tamifluTamiflu
  957. EU/3/24/2897 - orphan designation for treatment of focal segmental glomerulosclerosis
  958. 21 CFR 26.62: General obligations.
  959. EU/3/17/1924 - orphan designation for treatment of follicular lymphoma
  960. ema-extraneal-referralExtraneal - referral
  961. CHMP: meeting archive 2010-2012
  962. EU/3/23/2751 - orphan designation for treatment of glycogen storage disease type II…
  963. European Union (Clinical Trials on Medicinal Products for Human Use) (Principal…
  964. cdsco-bevacizumab-avastinBevacizumab AVASTIN
  965. EMEA-001765-PIP02-15-M04 - paediatric investigation plan
  966. Dapagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin…
  967. PSUSA/00002895/201811 - periodic safety update report single assessment
  968. ema-alkem-referralAlkem - referral
  969. Checklist for Quality-Related Documents for Biotechnology Products Derived from Cell Lines…
  970. Example of Documents on Assessment and Control of DNA Reactive (Mutagenic) Impurities…
  971. ema-dD
  972. ema-tremelimumab-astrazenecaTremelimumab AstraZeneca
  973. ema-pharmaceutical-industryPharmaceutical industry
  974. EU/3/03/163 - orphan designation for treatment of hyperphenylalaninaemia
  975. EMEA-002684-PIP02-21 - paediatric investigation plan
  976. cdsco-tocilizumabTocilizumab
  977. Tenth industry stakeholder platform on the operation of pharmacovigilance in the European…
  978. EMEA-001988-PIP01-16-M01 - paediatric investigation plan
  979. ICH E6 (R2) Good clinical practice - Scientific guideline
  980. 21 CFR 864.9245: Automated blood cell separator.
  981. NMPA Announcement on Revising the Package Insert of Antiviral Syrup, Capsules, Soft…
  982. PSUSA/00010207/201611 - periodic safety update report single assessment
  983. Japanese Encephalitis Vaccine Inactivated (Adsorbed, Human) I.P.
  984. EU recommendations for 2024/2025 seasonal flu vaccine composition
  985. ema-abiraterone-mylanAbiraterone Mylan
  986. Mother and Daughter Share a Passion for HTM
  987. Joint meeting of the EMA Scientific Committees' Working Party with Patients' and…
  988. PSUSA/00001629/201805 - periodic safety update report single assessment
  989. Notice regarding Regulatory approvals relating to combination products for HIV Hepatitis…
  990. Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 2: defining the scope of an NIRS procedure
  991. Opinions of the General Office of the State Council on Comprehensively Deepening the…
  992. ema-nobilis-influenza-h5n2Nobilis Influenza H5N2
  993. ema-exblifepExblifep
  994. EU/3/12/974 - orphan designation for treatment of primary hyperoxaluria type 1
  995. Magnesium
  996. EU/3/21/2545 - orphan designation for treatment of epileptic encephalopathy with…
  997. EU/3/23/2837 - orphan designation for treatment of limb-girdle muscular dystrophy

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