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Global regulations and guidance

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

  1. 21 CFR 868.5450: Respiratory gas humidifier.
  2. Insulin Glargine 100U/mL + Lixisenatide 33mcg/mL
  3. Regulation for Designation of Medical Device Clinical Trial Institute
  4. 21 CFR 82.1321: D&C Red No. 21.
  5. 21 CFR 884.2600: Fetal cardiac monitor.
  6. COVID-19 medicines under evaluation
  7. Radioactive Drug Research Committee
  8. Therapeutic goods advertising compliance: 2019-20 Annual Report
  9. FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety…
  10. EMEA-002652-PIP01-19 - paediatric investigation plan
  11. Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation…
  12. EU/3/20/2280 - orphan designation for treatment of marginal zone lymphoma
  13. Matthew B. Weinger: Can We Make Patient-Centered Care Really Patient Centered?
  14. Public Summary Version of PIC/S Road Map 2018-2020
  15. EU/3/18/1997 - orphan designation for treatment of Proteus syndrome
  16. New co-chairs elected for working parties for healthcare professionals and for patients…
  17. EU/3/24/2954 - orphan designation for treatment of Wolfram syndrome
  18. ema-circovacCircovac
  19. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  20. 21 CFR 866.4500: Immunoelectrophoresis equipment.
  21. PSUSA/00001169/201512 - periodic safety update report single assessment
  22. Prevexxion RN+HVT+IBD - opinion on variation to marketing authorisation
  23. ema-rabitecRabitec
  24. Referral opinions pending EC decision
  25. Rilvegostomig (AZD2936) Concentrate for solution for infusion 50 mg/mL (750 mg/vial) and…
  26. Midterm report on 2025 network strategy highlights good progress during critical period of…
  27. ema-tildren-referralTildren - referral
  28. Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party…
  29. Food and Drugs Act (R.S.C., 1985, c. F-27)
  30. PSUSA/00001854/201810 - periodic safety update report single assessment
  31. EU Big Data Stakeholder Forum
  32. EMEA-003279-PIP01-22 - paediatric investigation plan
  33. PDF Version (130 KB)
  34. cdsco-ligelizumab-qge031Ligelizumab (QGE031)
  35. EMEA-003164-PIP01-21 - paediatric investigation plan
  36. ema-preflucel-referralPreflucel - referral
  37. ema-erivedgeErivedge
  38. Guidance for completing SFDA On-line MDMA Application Form: AUSTRALIAN Jurisdiction
  39. PSUSA/00000082/201809 - periodic safety update report single assessment
  40. EU/3/21/2555 - orphan designation for treatment of chronic inflammatory demyelinating…
  41. Guidance for Industry on Management of Cybersecurity in Medical Devices(TFDA)
  42. September 12, 2017: Pediatric Advisory Committee Meeting Announcement - 09/12/2017
  43. FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug…
  44. 21 CFR 10.90: Food and Drug Administration regulations, recommendations, and agreements.
  45. International regulators’ reflections on remote approaches to GCP and GMP regulatory…
  46. 15th EudraVigilance information day
  47. EMA Management Board: highlights of October 2023 meeting
  48. Payment of Challan through Bharatkosh
  49. Juvenile animal studies (JAS) and impact on anti-cancer medicine development and use in…
  50. ema-quality-impuritiesQuality: impurities
  51. ema-emgalityEmgality
  52. Committee for Herbal Medicinal Products (HMPC): 30-31 January 2017
  53. Clinical trials applications for Coronavirus (COVID-19)
  54. Committee for veterinary medicinal products: Meeting of 11 to 13 November 2003
  55. fibrinogen concentrate (FIB Grifols)
  56. EU/3/10/827 - orphan designation for treatment of lysosomal acid lipase deficiency
  57. EU/3/05/277 - orphan designation for treatment of cystic fibrosis
  58. Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2011
  59. Central repository to facilitate assessment of medicines safety reports
  60. EU/3/15/1524 - orphan designation for treatment of long-chain 3-hydroxyacyl-coenzyme A…
  61. EU/3/20/2298 - orphan designation for treatment of sickle cell disease
  62. FAQ on IVD and Medical Device rule
  63. The Drug Establishment Licensing Bulletin
  64. TGA approved terminology for therapeutic goods
  65. Workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'
  66. The role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral…
  67. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 5-7 April 2011
  68. Public statement on Remicade (infliximab) - Reports of tuberculosis infections
  69. Nasolam and associated names - referral
  70. PSUSA/00001331/202109 - periodic safety update report single assessment
  71. 21 CFR 74.2205: D&C Green No. 5.
  72. 21 CFR 26.66: Designation and listing procedures.
  73. Naftifine hydrochloride cream 2%
  74. AZD9977 and Dapagliflozin
  75. European Medicines Agency gives further interim recommendations on dealing with…
  76. EU/3/16/1708 - orphan designation for treatment of hyperargininaemia
  77. EMEA-001219-PIP01-11-M06 - paediatric investigation plan
  78. EMEA-001606-PIP02-14 - paediatric investigation plan
  79. 21 CFR 868.5140: Anesthesia conduction kit.
  80. EMEA-002161-PIP01-17 - paediatric investigation plan
  81. 21 CFR 870.1875: Stethoscope.
  82. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical…
  83. Metoprolol IP + Chlorthalidone IP + Cilnidipine IP tablets (Phase III)
  84. EMA working on COVID-19 during closure on 1 and 2 November 2021
  85. Workshop on the role of registries in the monitoring of cancer therapies based on genetic…
  86. Clinical efficacy and safety: general
  87. cdsco-tirzepatideTirzepatide
  88. ema-cozaar-comp-referralCozaar Comp - referral
  89. Scientific Advice Working Party: veterinary medicines
  90. EMEA-000250-PIP01-08-M02 - paediatric investigation plan
  91. cdsco-pegfilgrastimPegfilgrastim
  92. Mammography Problems at San Sebastian X-Ray in San Sebastian, Puerto Rico: FDA Safety…
  93. EU/3/08/602 - orphan designation for treatment of chronic lymphocytic leukaemia
  94. GN-33 R2 Guidance on the Application of Singapore Standard GDPMDS (2023 Sep) PUB [PDF, 465…
  95. 21 CFR 10.35: Administrative stay of action.
  96. 21 CFR 886.1700: Pupillometer.
  97. EMEA-002234-PIP01-17 - paediatric investigation plan
  98. European Medicines Agency publishes new strategy on combating antimicrobial resistance
  99. Colloidal silver BP 50 ppm
  100. Lobeglitazone Sulfate 0.5mg + Glimepiride 1mg Tablets
  101. 21 CFR 872.3645: Subperiosteal implant material.
  102. 21 CFR 12.23: Notice of filing of objections.
  103. 21 CFR 814.39: PMA supplements.
  104. Committee for Medicinal Products for Human Use (CHMP): 22-25 February 2016
  105. 21 CFR 1.78: Biological products, HCT/Ps, and related drugs and medical devices.
  106. Annual report 2019 published
  107. cagrilintide 2.4 mg s.c.
  108. EU/3/09/709 - orphan designation for treatment of glioma
  109. 21 CFR 862.1170: Chloride test system.
  110. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - December 2016
  111. Chapter 4 - Nicotine Dose Guidance Northern Ireland
  112. 21 CFR 866.5660: Multiple autoantibodies immunological test system.
  113. MedEffectTM Canada Initiative - The Public Interface to Post-Market Surveillance Programs…
  114. 21 CFR 876.5010: Biliary catheter and accessories.
  115. 21 CFR 1.1117: How may an accreditation body request reinstatement of recognition?
  116. EU/3/01/073 - orphan designation for treatment of invasive fungal infections
  117. Committee for medicinal products for veterinary use: Meeting of 17 to 18 January 2006
  118. cagrilintide s.c. 2.4 mg
  119. Seventh Industry Standing Group (ISG) meeting
  120. Hiprabovis Pneumos - referral
  121. Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human…
  122. ema-shingrixShingrix
  123. Dapagliflozin + Sitagliptin film coated tablet (Phase III)M/s. Glenmark Pharmaceuticals…
  124. Medicinal cannabis manufacture
  125. EU/3/10/826 - orphan designation for treatment of tuberculosis
  126. Drug Alert list for month of October 2021
  127. Contacting EMA: post-authorisation
  128. ema-hemgenixHemgenix
  129. 21 CFR 870.2400: Vectorcardiograph.
  130. A.T.I. Steam Activated Heat Sensitive Indicators
  131. ema-aivlosinAivlosin
  132. EMEA-001588-PIP01-13-M03 - paediatric investigation plan
  133. Quality data requirements for applications for biological veterinary medicinal products…
  134. AAMI News, June 2022, Vol.57, No.6
  135. Joint Commission Checklist Proves ‘Instrument-al’ for Sterile Processing Department
  136. Alkindi - direct healthcare professional communication (DHPC)
  137. GN-15-R10 Guidance on Medical Device Product Registration (2024 Jan) PUB
  138. cdsco-sofosbuvir-velpatasvirSofosbuvir Velpatasvir
  139. AI Airlock pilot call for applications
  140. ICH Q4B Annex 11 Capillary electrophoresis - Scientific guideline
  141. Archive 1: Guidance on Risk Classification of Medical Device Observations (GUI-0079)
  142. ema-nyxoidNyxoid
  143. PSUSA/00001400/201702 - periodic safety update report single assessment
  144. Inviting comments on Revised Guidelines on Similar Biologics- Regulatory requirements for…
  145. ema-xeplionXeplion
  146. cdsco-levormeloxifeneLevormeloxifene
  147. ema-hH
  148. New medicine for hereditary rare disease
  149. EU/3/04/215 - orphan designation for treatment of cholangiocarcinoma
  150. ema-sprimeo-hctSprimeo HCT
  151. Medical devices reforms: An Action Plan for Medical Devices
  152. EU/3/03/138 - orphan designation for treatment of tricyclic anti-depressants poisoning
  153. PSUSA/00001850/201707 - periodic safety update report single assessment
  154. Delegation of the Powers- Import of Small Quantities of Drugs for Personal Use
  155. 21 CFR 866.5665: Aquaporin-4 autoantibody immunological test system.
  156. Standards Spotlight: Clinicians Can Help to Draft Healthy Standards for Medical Devices
  157. Risk of next-morning impairment after use of insomnia drugs; FDA requires lower…
  158. Paliperidone product-specific bioequivalence guidance
  159. cdsco-favipiravirFavipiravir
  160. Committee for Medicinal Products for Human Use (CHMP): 24-27 March 2025
  161. EU/3/24/2917 - orphan designation for treatment of Platelet-activating anti-Platelet…
  162. aami-guidelines-for-useGuidelines for Use
  163. Triamcinolone Acetonide Cream 0.1% w/w
  164. FDA Grants Marketing Authorization for Gait Improvement Device
  165. ema-fiprex-referralFiprex - referral
  166. EMEA workshop on Monoclonal Antibodies
  167. PSUSA/00003138/201512 - periodic safety update report single assessment
  168. Structure of the list of herbal substances, preparations and combinations thereof
  169. EMA starts new review of hydroxyethyl-starch containing medicines
  170. Marstacimab Prophylaxis
  171. EMA Management Board: highlights of December 2015 meeting
  172. cdsco-remdesivir-100-mgcRemdesivir 100 mgc
  173. How the TGA regulates software based medical devices
  174. Chapter 3 - Emissions Guidance - Great Britain: Chapter 3 - Emissions Guidance - GB
  175. EMEA-002942-PIP02-20-M01 - paediatric investigation plan
  176. Process validation for finished products – information and data to be provided in…
  177. PSUSA/00002908/201812 - periodic safety update report single assessment
  178. PIC/S Work Plan for 2020
  179. 21 CFR 5.1100: Headquarters.
  180. PSUSA/00010292/201903 - periodic safety update report single assessment
  181. Pharmaceutical quality of inhalation and nasal products - Scientific guideline
  182. Paediatric Committee (PDCO): 26 February-1 March 2019
  183. cdsco-gs-5745GS-5745
  184. Partial Revision of "Handling of Re-Examination Period"
  185. Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 May 2007
  186. ICH Q7 Good manufacturing practice for active pharmaceutical ingredients - Scientific…
  187. Clinical trials for medicines: Archiving and retention of clinical trial records
  188. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 January 2013
  189. EMA publishes report on workshop on regulatory options in the fight against antimicrobial…
  190. EU/3/15/1501 - orphan designation for treatment of haemophilia B
  191. EMA organisational changes come into effect
  192. Stem cell-based medicinal products - Scientific guideline
  193. Committee for Orphan Medicinal Products (COMP): 4-6 October 2022
  194. VA Shares Improvement Benchmarks for HTM Success
  195. Pharmacovigilance Risk Assessment Committee (PRAC): 4-8 July 2016
  196. ema-episalvanEpisalvan
  197. PSUSA/00000375/201510 - periodic safety update report single assessment
  198. ema-enerzair-breezhalerEnerzair Breezhaler
  199. (In Japanese)Basic principles on the utilization of health information databases for…
  200. Veterans Affairs Engineers Recognized With 2022 AAMI Award
  201. Refusal of orphan designation for treatment of off-periods in adult patients with advanced…
  202. PSUSA/00002001/202104 - periodic safety update report single assessment
  203. Nomegestrol / chlormadinone - direct healthcare professional communication (DHPC)
  204. 21 CFR 1.326: Who is subject to this subpart?
  205. ema-radicavaRadicava
  206. Importing medicines into Northern Ireland
  207. European Antibiotic Awareness Day: 18 November 2011
  208. 21 CFR 882.5897: External upper limb tremor stimulator.
  209. Aortic Covered Stent System Approved for Marketing
  210. EU/3/23/2871 - orphan designation for treatment of idiopathic pulmonary fibrosis
  211. 21 CFR 888.5960: Cast removal instrument.
  212. Zofenil, Zopranol, Bifril - referral
  213. 21 CFR 1.1360: Under what circumstances will FDA modify the requirements in this subpart…
  214. cdsco-semaglutide-2014Semaglutide 2014
  215. EU/3/05/279 - orphan designation for treatment of cutaneous T-cell lymphoma
  216. EMEA-001850-PIP01-15 - paediatric investigation plan
  217. EU/3/22/2667 - orphan designation for treatment of Wolfram syndrome
  218. 21 CFR 872.6250: Dental chair and accessories.
  219. European Medicines Agency recommends 14 medicines for use in animals in first half of 2014
  220. Paediatric Committee (PDCO): 14-16 April 2010
  221. EudraVigilance training on electronic reporting of Individual Case Safety Reports in the…
  222. EU/3/03/156 - orphan designation for treatment of adrenal insufficiency
  223. Investigator's Agreement in Accordance with Subsection 81(k) of the Medical Devices…
  224. Committee for Orphan Medicinal Products (COMP): 6-7 October 2010
  225. Dydrogesterone Extended Release Tablet 30mg
  226. Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 July 2011
  227. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  228. 21 CFR 1.513: What FSVP may I have if I am importing certain food from a country with an…
  229. KILMER Conference 2022 Promises a Bright Future for Sterility Assurance
  230. World TB Day – three new medicines recommended in last six months for patients with…
  231. Fentanyl-ratiopharm_TTS - referral
  232. cfr-21-cfr-82-1051-lakes-d-c21 CFR 82.1051: Lakes (D&C).
  233. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23…
  234. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2012
  235. Committee for medicinal products for veterinary use: Meeting of 6 to 8 December 2005
  236. EU/3/12/966 - orphan designation for treatment of soft tissue sarcoma
  237. Stakeholder workshop on support to quality development in early access approaches, such as…
  238. Pradaxa - Safety review of post-market reports of serious bleeding events with the…
  239. Axxonis Pharma AG withdraws its marketing authorisation application for Nenad (lisuride)
  240. cdsco-mavorixaforMavorixafor
  241. PSUSA/00001160/202111 - periodic safety update report single assessment
  242. EU/3/10/794 - orphan designation for treatment of primary myelofibrosis
  243. Details of Importers whose permissions have been suspended / cancelled 2020
  244. EMEA-001151-PIP01-11 - paediatric investigation plan
  245. GN-04-R2.2 Guidance on Medical Device Recall
  246. Meet Ollie, the Biomed ‘Device Doctor’ Who’s Teaching Children About Fixing Problematic…
  247. European Medicines Agency completes its review of Avastin used in breast cancer
  248. PSUSA/00010957/202304 - periodic safety update report single assessment
  249. Eschscholziae herba - herbal medicinal product
  250. UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety…
  251. Digital mental health technology: qualification and classification
  252. Paediatric Committee (PDCO): 14-16 July 2010
  253. Press Release on the cardiovascular safety of non-selective NSAIDs
  254. EMEA-001154-PIP02-15 - paediatric investigation plan
  255. EU/3/22/2612 - orphan designation for treatment of spinal cord injury
  256. PSUSA/00010442/201801 - periodic safety update report single assessment
  257. EU/3/19/2148 - orphan designation for treatment of Friedreich’s ataxia
  258. EMEA-003273-PIP01-22 - paediatric investigation plan
  259. cdsco-lipoproteinLipoprotein
  260. EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU
  261. PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis…
  262. Details of clinical trial Permissions of Year 2024
  263. Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices
  264. 21 CFR 1.1425: What must be included in a petition requesting a waiver for a type of…
  265. EMA's first public hearing: giving EU citizens a voice to help reduce the risk of…
  266. cdsco-tozorakimab-medi3506Tozorakimab (MEDI3506)
  267. EMEA-002475-PIP03-22 - paediatric investigation plan
  268. EMEA-002626-PIP01-19 - paediatric investigation plan
  269. ema-tienam-referralTienam - referral
  270. Diphtheria and Tetanus vaccine for Adults and Adolescents I.P (Td Vaccine)
  271. ema-ivabradine-anpharmIvabradine Anpharm
  272. EU/3/23/2866 - orphan designation for treatment of haemophilia B
  273. EU/3/13/1149 - orphan designation for prevention of ischaemia/reperfusion injury…
  274. 21 CFR 73.1075: Canthaxanthin.
  275. Management Board meeting: 16 March 2023
  276. Changing the (invented) name of a centrally authorised medicine: questions and answers
  277. Inactivated Hepatitis A vaccine (Adsorbed) I.P.
  278. EU/3/21/2455 - orphan designation for treatment of glioma
  279. Liquid Nasal Spray (Nitric oxide) (100 ppm)
  280. Tofacitinib film forming lotion 2% w/wCT/SND/19/2023
  281. EMEA-002387-PIP01-18 - paediatric investigation plan
  282. EU/3/09/684 - orphan designation for treatment of pancreatic cancer
  283. cdsco-sovateltideSovateltide
  284. EU/3/06/390 - orphan designation for treatment of moderate and severe traumatic brain…
  285. Clopidogrel Teva - referral
  286. ema-advasureAdvasure
  287. Merck Sharp & Dohme Ltd withdraws its marketing authorisation application for Vorinostat…
  288. Committee for veterinary medicinal products: 36th meeting
  289. EMEA-002863-PIP01-20 - paediatric investigation plan
  290. PSUSA/00010956/202207 - periodic safety update report single assessment
  291. cdsco-actg-5288ACTG 5288
  292. Water for Pharmaceutical Use
  293. EU/3/18/2002 - orphan designation for treatment of Crimean-Congo haemorrhagic fever
  294. Widening the availability of naloxone
  295. Reporting adverse incidents: joint replacement implants: Adverse incidents with joint…
  296. 21 CFR 862.3520: Kanamycin test system.
  297. EU/3/03/145 - orphan designation for treatment of pancreatic cancer
  298. PSUSA/00010442/201901 - periodic safety update report single assessment
  299. NMPA Announcement on Matters Related to the Implementation of the 2025 Edition of the…
  300. EMEA-002555-PIP02-21 - paediatric investigation plan
  301. Lupin Denosumab 60mg/mL
  302. EMEA-000389-PIP01-08-M01 - paediatric investigation plan
  303. Announcement of the “Implementation Items and Schedule of the Guide to Good Manufacturing…
  304. 21 CFR 862.1415: Iron-binding capacity test system.
  305. EMEA-002642-PIP01-19-M03 - paediatric investigation plan
  306. 21 CFR 71.25: Condition for certification.
  307. Therapeutic Comparative Advertising: Directive and Guidance Document
  308. Implementation of Pre-shipment inspection under testing
  309. ELIGLUSTAT SUBLINGUAL FILCT/SND/12/2024
  310. EudraVigilance training on electronic reporting of ICSRs in the European Economic Area
  311. Drug Safety Update: monthly PDF newsletter: Drug Safety Update February 2021
  312. EMEA-001999-PIP02-17-M01 - paediatric investigation plan
  313. 21 CFR 50.24: Exception from informed consent requirements for emergency research.
  314. 21 CFR 884.1640: Culdoscope and accessories.
  315. Application with 1. Meta-analyses; 2. One pivotal study - Scientific guideline
  316. EU/3/21/2443 - orphan designation for treatment of malignant hyperthermia
  317. Evaluation of Production Cleaning Processes for Electronic Medical Devices - Part 1…
  318. PSUSA/00001406/202208 - periodic safety update report single assessment
  319. PSUSA/00002067/201710 - periodic safety update report single assessment
  320. PRAC recommends suspending use of Protelos/Osseor
  321. Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices…
  322. Are you an SME interested in funding of Adverse Drug Reaction research through the…
  323. 21 CFR 830.210: Eligibility for use of FDA as an issuing agency.
  324. Policy on accessing the premises of a regulated party remotely to verify compliance…
  325. Azelnidipine 8 mg plus Metoprolol Succinate ER 50 mg tab and Azelnidipine 16 mg plus…
  326. Chapter 6 - Ingredient Guidance - Great Britain: Chapter 6 - Ingredient Guidance - GB
  327. Rivaroxaban Viatris (previously Rivaroxaban Mylan)
  328. World AIDS Day: 1 December 2012
  329. EU/3/22/2611 - orphan designation for treatment of focal segmental glomerulosclerosis
  330. Introductory Issue
  331. 2012.10.19_S.O. 2527(E)_Notification of Subrat Kumar CDL kolkata
  332. ema-xeljanz-referralXeljanz - referral
  333. 21 CFR 882.5870: Implanted peripheral nerve stimulator for pain relief.
  334. 3M Creates 3M Health Care Spin-Off, a Global Health Technology Company
  335. Using the TGA CMI template: Guidance for sponsors
  336. FDA Issues Draft Guidance for Including Human Factors Information in Medical Device…
  337. EMEA-001579-PIP01-13-M05 - paediatric investigation plan
  338. PIC/S Annex 1: Explanatory Notes for Industry on the Preparation of a Site Master file
  339. Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing…
  340. PSUSA/00010012/202004 - periodic safety update report single assessment
  341. EU/3/04/235 - orphan designation for treatment of type B extreme insulin resistance…
  342. EU/3/08/538 - orphan designation for treatment of small cell lung cancer
  343. cdsco-evobrutinibEvobrutinib
  344. Guidance for industry on MHRA’s expectations for return to UK on-site inspections
  345. Food and Drug Administration and European Medicines Agency agree to accept a single orphan…
  346. EU/3/13/1189 - orphan designation for treatment of myotonic disorders
  347. 21 CFR 21.21: Changes in systems and new systems.
  348. EU/3/17/1954 - orphan designation for treatment of mantle cell lymphoma
  349. cdsco-tin816TIN816
  350. European Commission/European Medicines Agency - US Food and Drug Administration bilateral…
  351. European Medicines Agency (EMA) and MedTech Europe bilateral meeting
  352. European Medicines Agency agrees to recall of Vimpat 15-mg/ml syrup
  353. ema-orphacolOrphacol
  354. cdsco-rilematovirRilematovir
  355. Committee for Orphan Medicinal Products (COMP): 21-23 May 2024
  356. EMA preparing guidance to tackle COVID-19 variants
  357. EU/3/23/2814 - orphan designation for treatment of sickle cell disease
  358. ema-biopoinBiopoin
  359. EU/3/05/315 - orphan designation for treatment of progressive myoclonic epilepsies
  360. Non-clinical evaluation of drug-induced liver injury (DILI) - Scientific guideline
  361. Potential Risk of Strangulation in Children Who Use Enteral Feeding Delivery Sets - FDA…
  362. 21 CFR 820.5: Quality system.
  363. cdsco-mepolizumabMepolizumab
  364. European Medicines Agency recommends approval of first vaccine for meningitis B
  365. Behind-the-Scenes Look at McKesson’s Security Efforts for Its COVID-19 Vaccine…
  366. EMEA-002036-PIP01-16 - paediatric investigation plan
  367. ema-hemoprostolHemoprostol
  368. Committee for Advanced Therapies (CAT): 18-20 January 2017
  369. AS P0013.005: Conducting Stage 1 Assessment Procedure
  370. ema-types-of-contractTypes of contract
  371. Arctii radix - herbal medicinal product
  372. Trinbelimab Injection 300 mcg/mL in Pre-filled Syringe.
  373. AAMI Foundation Names 2023 Award Winners
  374. Galcanezumab in Adolescent Patients
  375. David Braeutigam: Cybersecurity Is the New Electrical Safety Concern for HTM
  376. PSUSA/00000986/201809 - periodic safety update report single assessment
  377. 21 CFR 866.4070: RNA Preanalytical Systems.
  378. Article 141(1) opinions on any scientific matter: veterinary medicines
  379. Guidance for completing SFDA On-line MDMA Application Form: European Jurisdiction
  380. European Medicines Agency welcomes continuation of D:A:D study
  381. Questions and answers on post approval change management protocols - Scientific guideline
  382. 21 CFR 890.5420: Electroencephalography (EEG)-driven upper extremity powered exerciser.
  383. 21 CFR 866.3255: Escherichia coli serological reagents.
  384. PSUSA/00001856/201412 - periodic safety update report single assessment
  385. 21 CFR 862.3580: Lysergic acid diethylamide (LSD) test system.
  386. ema-galafoldGalafold
  387. Notice regarding Review of regulatory regime for drug approval
  388. EMEA-000731-PIP01-09-M03 - paediatric investigation plan
  389. EMEA-002472-PIP03-22-M01 - paediatric investigation plan
  390. Committee for Orphan Medicinal Products (COMP): 5-6 January 2010
  391. Non-clinical and clinical development of similar biological medicinal products containing…
  392. cdsco-sep-02-2014-gsr-633-eSep 02 2014 GSR 633(E)
  393. ema-mvabeaMvabea
  394. ema-kerendiaKerendia
  395. EMA starts review of cancer medicine Rubraca
  396. EU/3/16/1673 - orphan designation for treatment of fragile X syndrome
  397. PSUSA/00009004/202007 - periodic safety update report single assessment
  398. EMEA-001492-PIP02-18 - paediatric investigation plan
  399. 21 CFR 20.45: Fees to be charged.
  400. Substances related to nicotinic acid - referral
  401. PSUSA/00001819/202009 - periodic safety update report single assessment
  402. 21 CFR 20.24: Preparation of new records.
  403. 21 CFR 866.5210: Ceruloplasmin immunological test system.
  404. Safety and residue data requirements for applications for non-immunological veterinary…
  405. Data quality framework for medicines regulation
  406. ema-wegovyWegovy
  407. Handling of Non-proprietary Names and Brand Names related to Biosimilars
  408. Committee for Orphan Medicinal Products: November 2005 meeting
  409. Corlentor and Procoralan - referral
  410. 21 CFR 73.140: Toasted partially defatted cooked cottonseed flour.
  411. EudraVigilance training on electronic reporting of individual case safety reports (ICSRs)…
  412. Assurances to accompany an OTC new medicine N1 application
  413. Antimicrobial Advice Ad Hoc Expert Group
  414. Voices of HTM: Madeline Rozsa
  415. cdsco-lci699LCI699
  416. Biological and chemical threats
  417. 21 CFR 870.3470: Intracardiac patch or pledget made of polypropylene, polyethylene…
  418. Transfer-Agreement-Draft-1.0
  419. Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 May 2016
  420. 21 CFR 886.1810: Tangent screen (campimeter).
  421. EMEA-001931-PIP01-16-M02 - paediatric investigation plan
  422. Ozenoxacin Lotion 2% W/v
  423. PSUSA/00003170/201508 - periodic safety update report single assessment
  424. 2023.05.15_CR_Draft G.S.R. 371(E)_Certain amendments in Cosmetics Rule 2020
  425. Clinical investigation of recombinant and human plasma-derived factor VIII products…
  426. Drug Alert for the Month of November 2023
  427. 21 CFR 872.1850: Lead-lined position indicator.
  428. EU/3/21/2430 - orphan designation for treatment of Barth syndrome
  429. 21 CFR 56.121: Disqualification of an IRB or an institution.
  430. Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and…
  431. First oral monotherapy for patients with paroxysmal nocturnal haemoglobinuria
  432. ema-zilbrysqZilbrysq
  433. AAMI and MedCrypt Establish Cybersecurity Visionary Award
  434. PSUSA/00001594/201706 - periodic safety update report single assessment
  435. ema-sugammadex-mylanSugammadex Mylan
  436. PSUSA/00010245/201503 - periodic safety update report single assessment
  437. GN-12-2-R2 Guidance on Grouping-Specific (2022 Jan) PUB [PDF, 447 KB]
  438. 21 CFR 801.110: Retail exemption for prescription devices.
  439. ema-emblaveoEmblaveo
  440. EMEA-001877-PIP01-15-M02 - paediatric investigation plan
  441. ema-neurontin-referralNeurontin - referral
  442. EU/3/22/2710 - orphan designation for treatment of tuberculosis
  443. Human Cells, Tissues And Organs (CTO) For Transplantation Establishment Registration…
  444. Classification of biologicals
  445. EU/3/22/2688 - orphan designation for treatment of myelodysplastic syndromes
  446. cdsco-bay94-8862BAY94-8862
  447. 21 CFR 810.16: Cease distribution and notification or mandatory recall order status…
  448. EMEA-000823-PIP01-10 - paediatric investigation plan
  449. EMEA-001196-PIP01-11 - paediatric investigation plan
  450. ema-twynstaTwynsta
  451. EMEA-001844-PIP01-15 - paediatric investigation plan
  452. Points to Consider for Replacement of Conventional Tests for Viruses with Next Generation…
  453. Consultation: Draft Guidance on Good Manufacturing Practices (GMP) for Medical Gases…
  454. Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19)…
  455. Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension
  456. Use of market authorisation evidence from comparable overseas regulators / assessment…
  457. Supply shortage of Cerezyme – updated treatment recommendations required
  458. Metformin Hydrochloride IP (as sustained release) + Vildagliptin (as sustained release) +…
  459. TR-01 R2 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (2023…
  460. European Medicines Agency Human Scientific Committee's Working Party with Healthcare…
  461. 21 CFR 60.20: FDA action on regulatory review period determinations.
  462. EMEA-003146-PIP01-21 - paediatric investigation plan
  463. Hydroxyethyl starch (HES) containing medicinal products - referral
  464. Medicinal Products (Control of Manufacture) (Amendment) (No 2) Regulations 2022 (SI…
  465. Health technology assessment bodies
  466. Appendix 13 Guidance on MIV Applications for Chemical Therapeutic Products
  467. Acipimox only to be used as additional or alternative treatment to reduce high…
  468. 21 CFR 870.1420: Coronary artery disease risk indicator using acoustic heart signals.
  469. PSUSA/00001124/202011 - periodic safety update report single assessment
  470. CVMP recommendations on limited market classification and eligibility for authorisation…
  471. Polycaprolactone (PCL)
  472. NMPA Released Announcement on the Application of 15 ICH Guidelines Including E1: Extent of…
  473. 21 CFR 1.623: What reports and notifications must a recognized accreditation body submit…
  474. Notice regarding creation of databases of drug manufacturing facilities and approved drug…
  475. 21 CFR 884.2720: External uterine contraction monitor and accessories.
  476. EU/3/12/1025 - orphan designation for treatment of Berardinelli-Seip syndrome
  477. Webinar on EMA’s categorisation of antibiotics used in animals
  478. List of Drugs Medical Devices Vaccine and Cosmetics declared as Spurious for the Month of…
  479. Enzalutamide product-specific bioequivalence guidance
  480. EMEA-002831-PIP01-20 - paediatric investigation plan
  481. cdsco-darolutamidedarolutamide
  482. PSUSA/00010184/201412 - periodic safety update report single assessment
  483. EU/3/02/115 - orphan designation for treatment of uraemic pruritus
  484. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 July 2012
  485. Paediatric Committee (PDCO): 8-11 November 2016
  486. ema-cokieraCokiera
  487. ema-non-clinical-developmentNon-clinical development
  488. Increasing access to reports on adverse reactions to medicines
  489. EU/3/18/2035 - orphan designation for treatment of growth hormone deficiency
  490. Statistical principles for clinical trials for veterinary medicinal products…
  491. GSR 220(E) Dt. 26.03.2020_Doorstep delivery of the drugs by retail _Section 26B
  492. ema-suliquaSuliqua
  493. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  494. 21 CFR 870.3680: Cardiovascular permanent or temporary pacemaker electrode.
  495. Cyberattack on EMA - update 4
  496. European Medicines Agency invites feedback on the draft guideline on clinical…
  497. Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2019 (SI…
  498. Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting…
  499. S.O. 2451(E)_Exemption of hand sanitizer from sale licence_Section 26B
  500. Committee for Herbal Medicinal Products (HMPC): 4-5 May 2015
  501. PSUSA/00001437/201410 - periodic safety update report single assessment
  502. Avinash Konkani: Striking a Balance Between BMETs and Clinical Engineers
  503. Mattress decontamination: poster: Mattress decontamination poster
  504. Herceptin, Alimta and Remicade batches concerned by ongoing investigation
  505. Addressing Cybersecurity’s ‘First Mile Problem’
  506. 21 CFR 866.3380: Mumps virus serological reagents.
  507. PSUSA/00002769/201706 - periodic safety update report single assessment
  508. EU/3/23/2885 - orphan designation for treatment of patients undergoing haematopoietic stem…
  509. 21 CFR 7.13: Suggested forms of guaranty.
  510. EMA Human Scientific Committees' Working Parties with Patients' and Consumers'…
  511. 21 CFR 12.50: Advice on public participation in hearings.
  512. October 22, 2018: Science Board to the FDA Meeting Announcement - 10/22/2018
  513. EU/3/02/085 - orphan designation for treatment of glioma
  514. To Inspire High School Students, AAMI and CBET Launch New HTM Career Campaign
  515. ema-folotynFolotyn
  516. Fampridine - paediatric investigation plan
  517. ema-dutrebisDutrebis
  518. Committee for Advanced Therapies (CAT): 15-16 July 2010
  519. 21 CFR 1.279: When must prior notice be submitted to FDA?
  520. EMA appoints Chief Medical Officer
  521. cdsco-ad26-cov2-sAd26.COV2.S
  522. Good Manufacturing Practices (GMP) - Establishment Licence (EL) Information Sessions
  523. 21 CFR 82.6: Certifiable mixtures.
  524. EU/3/05/308 - orphan designation for treatment of hyperphenylalaninaemia
  525. 21 CFR 11.2: Implementation.
  526. ema-rystiggoRystiggo
  527. Avinash Konkani: What to Look for in Medical Lights
  528. Vemurafenib product-specific bioequivalence guidance
  529. DR_G.S.R. 444(E) dt_30.04.1992_26A_reg all cosmetics licensed as tooth pastes, tooth…
  530. cdsco-zy19489ZY19489
  531. ema-aybintioAybintio
  532. PSUSA/00010330/202001 - periodic safety update report single assessment
  533. Risk management plans (RMP) in post-authorisation phase: questions and answers
  534. ema-hydroxyzine-referralHydroxyzine - referral
  535. Drug Alert list for month of March 2018
  536. P/36/2011 - paediatric investigation plan
  537. Accessing key EMA information on human medicines
  538. EMEA/H/N/PSR/J/0002 - periodic safety update report single assessment
  539. 21 CFR 864.5400: Coagulation instrument.
  540. PSUSA/00000171/201902 - periodic safety update report single assessment
  541. PSUSA/00001996/202101 - periodic safety update report single assessment
  542. EMEA-002714-PIP01-19 - paediatric investigation plan
  543. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 February 2015
  544. 21 CFR 866.3: Effective dates of requirement for premarket approval.
  545. EMEA-003021-PIP01-21 - paediatric investigation plan
  546. ema-darunavir-krkaDarunavir Krka
  547. European Union (EU) International Organization for Standardization (ISO) identification of…
  548. Guidance for the interpretation of sections 28 to 31: Licence application type
  549. Quality of oral modified release products - Scientific guidelines
  550. Standard paediatric investigation plans
  551. Medical devices regulations: compliance and enforcement
  552. Siloxanes, often used in breast implants
  553. (Tri­Council Policy Statement) Ethical Conduct for Research Involving Humans
  554. EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
  555. EMEA-002588-PIP01-19 - paediatric investigation plan
  556. Reduction of assessment fees for medical devices
  557. Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP +…
  558. European Medicines Agency recommends approval of medicine for reduction of alcohol…
  559. Collaboration on neonatal issues between researchers and the European Medicines Agency
  560. Core summary of product characteristics (SmPC) and package leaflet for fludeoxyglucose…
  561. Provision for Risk Classification of In-Vitro Diagnostic Medical Devices on the CDSCO…
  562. Budesonide, Glycopyrronium
  563. EMEA-001464-PIP01-13 - paediatric investigation plan
  564. Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL
  565. European Medicines Agency (EMA)/European Society for Medical Oncology (ESMO) Rare Cancers…
  566. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 18-21…
  567. PSUSA/00010300/201603 - periodic safety update report single assessment
  568. Joint EMEA/IFAH-Europe Info Day
  569. Investigation of chiral active substances (veterinary) - Scientific guideline
  570. Pioglitazone Hydrochloride IP eq. to Pioglitazone + Sitagliptin Phosphate…
  571. 21 CFR 82.1708: D&C Yellow No. 8.
  572. Committee for Orphan Medicinal Products (COMP): 6-7 April 2011
  573. EU/3/12/1021 - orphan designation for prevention of poliomyelitis in patients with…
  574. Sanofi Pasteur withdraws its marketing authorisation application for Emerflu, pandemic…
  575. Taraxaci officinalis radix - herbal medicinal product
  576. Committee for Advanced Therapies (CAT): 11-12 October 2012
  577. EU/3/12/1001 - orphan designation for treatment of ovarian cancer
  578. ema-anti-fraud-strategyAnti-fraud strategy
  579. Committee for Medicinal Products for Human Use (CHMP): 16-19 August 2021
  580. S (-) Metoprolol Succinate IH + Efonidipine Hydrochloride Ethanolate IH modified release…
  581. Yadin David: Building Connections in the Clinical Engineering World with an International…
  582. Potency labelling for insulin analogue containing products with particular reference to…
  583. 21 CFR 874.3900: Nasal dilator.
  584. EMEA-000480-PIP01-08-M14 - paediatric investigation plan
  585. (Appendix 2) The Standards for Marketing Approval of Antipyretic Analgesics
  586. EU/3/20/2372 - orphan designation for treatment of glioma
  587. Preparation of a Premarket Review Document for Breast Implant and Tissue Expander…
  588. Clarice Holden: Navigating the Interview from Both Sides of the Table
  589. William Hyman: Closed-Loop Control and Patient Equipment
  590. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  591. 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA)
  592. EMA announces final steps for its clinical-trial data policy
  593. Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting…
  594. EU/3/14/1428 - orphan designation for treatment of Wolfram syndrome
  595. Empagliflozin + Metformin Hydrochloride IP (as sustained release) (10mg + 1000mg & 25mg +…
  596. ema-benfluorex-referralBenfluorex - referral
  597. Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 October 2020
  598. Core summary of product characteristics for human plasma coagulation factor VII products…
  599. Multi-stakeholder workshop to further improve the implementation of the Paediatric…
  600. EMEA-002989-PIP01-21-M01 - paediatric investigation plan
  601. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24-27…
  602. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11…
  603. 21 CFR 876.3500: Penile implant surgical accessories.
  604. Generic and hybrid applications
  605. ema-internal-errorInternal error
  606. 21 CFR 73.3100: 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione…
  607. cdsco-noticeNotice
  608. European Medicines Agency recommends revocation of marketing authorisations for bufexamac
  609. Checklist -Public Notice regarding Self assessment tools for drug regulator/stakeholders…
  610. Clinical investigation of medicinal products for the treatment of pulmonary arterial…
  611. Big data use for public health: publication of Big Data Steering Group workplan 2022-25
  612. William Hyman: The Little-Discussed Device Learning Curve
  613. Workshop– significant benefit of orphan drugs: concepts and future developments
  614. cdsco-ly3841136LY3841136
  615. EU/3/20/2359 - orphan designation for treatment of frontotemporal dementia
  616. Notification on Gateway Application
  617. Hiprabovis IBR Marker Live - direct healthcare professional communication (DHPC)
  618. Medicines regulators to work together internationally to find innovative solutions to…
  619. FDA’s New Quality Regulations: Make Sure It’s on Your Radar
  620. Additional trade names application form
  621. Committee for Medicinal Products for Human Use (CHMP): 8-11 November 2021
  622. ema-covid-19-medicinesCOVID-19 medicines
  623. Clinical trial notification (CTN) form - user guide
  624. Guido Rasi takes office as head of EMA
  625. cdsco-dulaglutideDulaglutide
  626. EMEA-001175-PIP01-11-M04 - paediatric investigation plan
  627. 21 CFR 878.4700: Surgical microscope and accessories.
  628. Wording of Helicobacter pylori eradication therapy in selected…
  629. EMEA-000856-PIP01-10 - paediatric investigation plan
  630. BMS-986454 Injection 150 mg/mL (300 mg/vial) (r-DNA origin)
  631. Making the Best BMET Internship for Students and Supervisors Alike
  632. cdsco-stn1010904STN1010904
  633. Health Product Complaint Form (FRM-0317)
  634. 21 CFR 868.5165: Nitric oxide administration apparatus.
  635. Mycobacterium w (Heat KilledInjection
  636. Levobupivacaine Hydrochloride eq. to Levobupivacaine + Dextrose liquid injection (Phase…
  637. EMA surveys pharma companies on their preparedness for Brexit
  638. Committee for Advanced Therapies (CAT): 22-24 January 2020
  639. Testing Laboratories approved by Statas&UT in Form 37 of Drugs Rule 1945 and Cos 23 of…
  640. ema-patients-and-carersPatients and carers
  641. Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone
  642. EudraVigilance information day
  643. 21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer porous-coated uncemented…
  644. ema-inovelonInovelon
  645. EMEA-001491-PIP01-13-M02 - paediatric investigation plan
  646. Annual workshop of the European network of paediatric research at the European Medicines…
  647. EU/3/06/394 - orphan designation for treatment of follicular lymphoma
  648. PSUSA/00010070/202111 - periodic safety update report single assessment
  649. ema-bondronatBondronat
  650. Chantix (varenicline) drug label now contains updated efficacy and safety information
  651. 21 CFR 886.1860: Ophthalmic instrument stand.
  652. PSUSA/00010290/201701 - periodic safety update report single assessment
  653. Finding ‘Enlightenment’ on Sterile Processing at the AAMI eXchange
  654. Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 April 2018
  655. 21 CFR 886.1300: Afterimage flasher.
  656. Getting ready for EMA’s website relaunch on 5 December 2023
  657. Submitting changes to labelling and patient information leaflets
  658. 2020.06.05 Draft GSR 354 E compassionate use of new drug
  659. Molnupiravir Moderateapl
  660. Clinical investigation of recombinant and human plasma-derived factor IX products…
  661. cdsco-list-of-pusr-meeting17List of PUSR meeting17
  662. EU/3/15/1596 - orphan designation for treatment of partial deep dermal and full-thickness…
  663. Strengthening engagement between EMA and general practitioners
  664. Senvelgo - direct healthcare professional communication (DHPC)
  665. EU/3/18/1979 - orphan designation for treatment of haemophilia A
  666. 21 CFR 73.2995: Luminescent zinc sulfide.
  667. PSUSA/00000858/201807 - periodic safety update report single assessment
  668. Meeting highlights from the Committee for Medicinal Products for Human Use,16-19 March…
  669. ema-credelio-plusCredelio Plus
  670. ema-dacogenDacogen
  671. First triple combination therapy for asthma with optional electronic sensor
  672. ema-incellipanIncellipan
  673. EU/3/23/2849 - orphan designation for treatment of Gaucher disease
  674. EU/3/09/707 - orphan designation for treatment of idiopathic pulmonary fibrosis
  675. Cancellation of registration of cosmetic product QR 678- Neo issued under RC/COS-OO1410…
  676. GN-23-R1 Guidance on Labelling for Medical Devices [ARCHIVED on 1 Mar 2020] [PDF, 355 KB]
  677. Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK)
  678. Paclitaxel Hetero and associated names - referral
  679. 21 CFR 880.6980: Vein stabilizer.
  680. Committee for Orphan Medicinal Products (COMP): 5-6 May 2010
  681. EU/3/22/2721 - orphan designation for treatment of biliary tract cancer
  682. Focus on Service and Repairs: Medical Equipment Service Guide Helps Ensure Safety and…
  683. Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline
  684. Drug Safety Update: monthly PDF newsletter: Drug Safety Update February 2020
  685. EMEA-001184-PIP01-11 - paediatric investigation plan
  686. EMA identifies gaps in industry preparedness for Brexit
  687. Recombinant Hepatitis E Vaccine
  688. Molnupiravir Moderater1
  689. Plendil and associated names - referral
  690. 21 CFR 866.2410: Culture medium for pathogenic Neisseria spp.
  691. Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
  692. GN-02-R4.4 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD…
  693. cdsco-ianalumab-ct-22-000006Ianalumab CT/22/000006
  694. EMEA-002965-PIP01-21-M02 - paediatric investigation plan
  695. cdsco-ckd-314CKD-314
  696. Submitting data in the eCTD format
  697. 2019.07.19 S.O. 2607_Prohibition of Colistin for food producing animals, poultry, aqua…
  698. cdsco-ly3502970lLY3502970l
  699. Notice dated 08.05.2013: Clarification sought by the stakeholders
  700. 21 CFR 884.4150: Bipolar endoscopic coagulator-cutter and accessories.
  701. Delegation of powers of Licensing Authority under Rule 22 of Drugs & Cosmetics Rules
  702. PSUSA/00000986/202209 - periodic safety update report single assessment
  703. Biosimilar Medicinal Products Working Party
  704. Opatanol - withdrawal of application for variation to marketing authorisation
  705. CVMP: Working parties and other groups
  706. ema-nexobridNexoBrid
  707. National Symposium on Point-of-care Manufacturing of medical devices
  708. EU/3/03/152 - orphan designation for treatment of cystic fibrosis
  709. Committee for Herbal Medicinal Products (HMPC): 22-24 July 2024
  710. Field Compliance Testing of Diagnostic Medical X-Ray Equipment
  711. Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During…
  712. EMEA-002221-PIP01-17 - paediatric investigation plan
  713. Meeting Notice regarding 8th meeting of Central Expert Committee to determine quantum of…
  714. European Medicines Agency recommends authorisation of Vimpat syrup for patients who cannot…
  715. 21 CFR 73.352: Paracoccus pigment.
  716. European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2012…
  717. EU/3/16/1806 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  718. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - February…
  719. 21 CFR 878.4683: Non-Powered suction apparatus device intended for negative pressure wound…
  720. ema-brintellixBrintellix
  721. 21 CFR 56.123: Reinstatement of an IRB or an institution.
  722. Working parties for healthcare professionals and for patients and consumers elect new…
  723. cfr-21-cfr-14-1-scope21 CFR 14.1: Scope.
  724. 21 CFR 890.3710: Powered communication system.
  725. Novel Corona virus-2019-nCoV Vaccine (recombinant)
  726. EU/3/05/332 - orphan designation for treatment of acute myeloid leukaemia
  727. PSUSA/00002126/201702 - periodic safety update report single assessment
  728. Environmental risk assessment of veterinary medicines
  729. Procedure to be followed for regularisation of FDCs declared as rational in respect to 294…
  730. 21 CFR 864.9125: Vacuum-assisted blood collection system.
  731. 2020 AAMI Fellows Honored for Achievements, Commitment to AAMI Mission
  732. ema-gencebokGencebok
  733. cdsco-tirzepatidenTirzepatiden
  734. ema-hmpc-membersHMPC members
  735. 21 CFR 870.5910: Esophageal thermal regulation device.
  736. Constitution of Central Expert Committee to determine the quantum of compensation in…
  737. EMEA-000469-PIP01-08-M07 - paediatric investigation plan
  738. EU/3/05/268 - orphan designation for treatment of renal-cell carcinoma
  739. Nitisinone MDK (previously Nitisinone MendeliKABS)
  740. European Medicines Agency and US Food and Drug Administration release further guidance on…
  741. European Medicines Agency: Committee for Medicinal Products for Human Use 10-13 October…
  742. Post-marketing surveillance studies for metered dose inhalers with new propellant…
  743. 28 February 2013 - Rare Disease Day: 'Rare disorders without borders'
  744. ema-synchron-referralSynchron - referral
  745. Tips, Best Practices, and Updates on FDA 510(k) Program
  746. ICH M12 on drug interaction studies - Scientific guideline
  747. KILMER Conference 2025 – Call for Abstracts
  748. Suzanne Steidl: Great Work! Now Make It Available to Me, Please
  749. Press briefings and stakeholder meetings
  750. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28…
  751. European Medicines Agency closed Monday 27 August
  752. EU/3/22/2669 - orphan designation for treatment of nasopharyngeal cancer
  753. Data requirements for intravenous iron-based nano-colloidal products developed with…
  754. ema-nobilis-ib-4-91Nobilis IB 4-91
  755. PSUSA/00001236/202203 - periodic safety update report single assessment
  756. Regulatory information – adjusted fees for pharmacovigilance applications from 3 October…
  757. List of medical devices testing laboratory (MDTL) for carry out test or evaluation of…
  758. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 December 2013
  759. ema-sondelbaySondelbay
  760. Axumin - withdrawal of application for variation to marketing authorisation
  761. cdsco-mk-1084MK 1084
  762. EU/3/15/1568 - orphan designation for treatment of Middle East respiratory syndrome
  763. Workshop on clinical development and scientific advice in ophthalmology
  764. cdsco-bemcentinibBemcentinib
  765. cdsco-nintedanib-oralNintedanib oral
  766. PSUSA/00001814/202002 - periodic safety update report single assessment
  767. cfr-21-cfr-860-1-scope21 CFR 860.1: Scope.
  768. First EMEA workshop on ethics in clinical trials - Use of placebo in clinical trials
  769. Meeting highlights from the Paediatric Committee: 29 - 31 August 2007
  770. Goserelin 10.8mg Injection1
  771. Rise of AI Demonstrates the Importance of Standards Development
  772. PSUSA/00000227/202211 - periodic safety update report single assessment
  773. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 17-20…
  774. Oral Bisphosphonates - Safety update for osteoporosis drugs, bisphosphonates, and atypical…
  775. Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2024
  776. Pharmacovigilance: Overview
  777. 21 CFR 862.1185: Compound S (11-deoxycortisol) test system.
  778. 21 CFR 884.5160: Powered breast pump.
  779. Sub Standard Quality of Human Albumin IP/EP Albiomin Solution for infusion
  780. Cyproterone-containing medicinal products - referral
  781. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19…
  782. Voices of HTM: Codi Nelson
  783. Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2010
  784. Industry Update webinar on Regulatory Procedure Management for Product Lifecycle…
  785. Electronic-application-form term-request webinar
  786. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18…
  787. Committee for Orphan Medicinal Products (COMP): 18-20 February 2020
  788. Management Board meeting: 3 October 2024
  789. Requirements for demonstrating therapeutic equivalence between orally inhaled products…
  790. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14…
  791. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
  792. PSUSA/00001346/202210 - periodic safety update report single assessment
  793. Medicines: get scientific advice from MHRA
  794. EMEA-000366-PIP01-08-M06 - paediatric investigation plan
  795. TEAM-NB-MD Survey 2014.pptx
  796. The new EudraVigilance system and the electronic reporting of individual case safety…
  797. Core summary of product characteristics for human plasma derived von Willebrand factor…
  798. Development of medicines for rare diseases
  799. EU/3/20/2325 - orphan designation for treatment of GM2 gangliosidosis
  800. Periodic safety update report information day
  801. cfr-21-cfr-882-1750-pinwheel21 CFR 882.1750: Pinwheel.
  802. Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA…
  803. 21 CFR 814.104: Original applications.
  804. Novartis Europharm Ltd withdraws its marketing authorisation application for Rasival…
  805. Registration opens for joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop
  806. 21 CFR 14.82: Nominations of voting members of standing advisory committees.
  807. ema-pomalidomide-krkaPomalidomide Krka
  808. ema-nulojixNulojix
  809. RESOLUTION RDC NO. 36, 26 AUGUST 2015
  810. Testing of paediatric medicinal cannabis products being supplied via SAS in Australia
  811. EU/3/05/276 - orphan designation for treatment of B-cell chronic lymphocytic leukaemia
  812. Meningococcal(A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze-Dried)
  813. ema-acompliaAcomplia
  814. Norton Healthcare Clinical Engineering’s Journey Toward ISO 13485 Certification
  815. EU/3/17/1850 - orphan designation for treatment of ornithine transcarbamylase deficiency
  816. PSUSA/00000314/202105 - periodic safety update report single assessment
  817. EMEA-002568-PIP01-19 - paediatric investigation plan
  818. CAT-Translational Centre for Regenerative Medicine Leipzig collaborative workshop…
  819. EMEA-002127-PIP01-17-M01 - paediatric investigation plan
  820. Committee for Advanced Therapies (CAT): 20-21 April 2016
  821. DR_G.S.R. 140(E) dt_26.02.2021_Schedule K at serial number 23 to include Anganwadi worker
  822. PSUSA/00002213/201705 - periodic safety update report single assessment
  823. List of Approved Products
  824. Twenty-ninth meeting of the Management Board
  825. EMEA-001656-PIP02-19 - paediatric investigation plan
  826. 21 CFR 74.1333: D&C Red No. 33.
  827. Second biannual Big Data Steering Group and industry stakeholders meeting 2023
  828. 21 CFR 801.437: User labeling for devices that contain natural rubber.
  829. PSUSA/00009316/201712 - periodic safety update report single assessment
  830. PSUSA/00002591/201604 - periodic safety update report single assessment
  831. Typhoid Vi Conjugate Vaccine I.P.
  832. Guidance document for approval of ba/be noc for export purpose as per schedule y & test…
  833. Eighth meeting of the industry stakeholder platform on the operation of the centralised…
  834. ema-evictoEvicto
  835. EMEA-001384-PIP01-12 - paediatric investigation plan
  836. cdsco-fibrinogenFibrinogen
  837. ema-topotecan-sunTopotecan SUN
  838. EU/3/16/1777 - orphan designation for treatment of smallpox
  839. Report: Dramatic Increase in Patient Records Exposed in Data Breaches for 2023
  840. 21 CFR 882.5808: Transcranial magnetic stimulator for headache.
  841. ema-daquiranDaquiran
  842. Team-NB Press Release IVDR Applications Survey 20190117
  843. PSUSA/00001910/201412 - periodic safety update report single assessment
  844. AAMI Response to GI Societies Joint Statement on ANSI/AAMI ST91
  845. 21 CFR 868.2375: Breathing frequency monitor.
  846. Revised guideline to assess risk of human medicines for the environment
  847. Guidance on submission of single assessment PSURs published
  848. PSUSA/00000964/201712 - periodic safety update report single assessment
  849. 21 CFR 886.1375: Bagolini lens.
  850. Human regulatory: overview
  851. William Hyman: How Promising Is the NPSD?
  852. Drugs Alert for the month of December 2014
  853. Application guidance (veterinary medicines)
  854. Workshop: User testing and how to review the data
  855. cdsco-sputnik-lightSputnik Light
  856. EU/3/03/182 - orphan designation for treatment of aneurysmal subarachnoid haemorrhage
  857. PSUSA/00003158/201603 - periodic safety update report single assessment
  858. Notice dated 09.05.2016 regarding Sugam Online Medical Devices
  859. 21 CFR 20.80: Applicability of limitations on exemptions.
  860. Final Report on the Australian Government Response to the Recommendations of the Senate…
  861. EU/3/14/1403 - orphan designation for treatment of WHIM syndrome
  862. Management Board: Meetings 2018
  863. EMEA-002694-PIP01-19 - paediatric investigation plan
  864. EU/3/13/1128 - orphan designation for treatment of adrenocortical carcinoma
  865. EMEA-002115-PIP01-17-M05 - paediatric investigation plan
  866. Committee for Proprietary Medicinal Products (CPMP) 22nd plenary meeting
  867. ema-carbagluCarbaglu
  868. Committee for Orphan Medicinal Products (COMP): 2-3 February 2010
  869. ema-iprezivIpreziv
  870. 21 CFR 810.15: Communications concerning a cease distribution and notification or…
  871. EU/3/22/2615 - orphan designation for treatment of fragile X syndrome
  872. EMEA-002897-PIP01-20 - paediatric investigation plan
  873. EU/3/21/2514 - orphan designation for treatment of amyotrophic lateral sclerosis
  874. PSUSA/00010324/202012 - periodic safety update report single assessment
  875. 21 CFR 870.4210: Cardiopulmonary bypass vascular catheter, cannula, or tubing.
  876. Procedures for Public Release of Information on Review of Applications for New Medical…
  877. cdsco-20112011
  878. cfr-21-cfr-812-1-scope21 CFR 812.1: Scope.
  879. 21 CFR 878.4165: Wound autofluorescence imaging device.
  880. PSUSA/00000171/201602 - periodic safety update report single assessment
  881. ema-actosActos
  882. 21 CFR 12.130: Decision by Commissioner on appeal or review of initial decision.
  883. NMPA issued the Announcement on Implementing Electronic Application of Medical Device…
  884. 21 CFR 1.281: What information must be in a prior notice?
  885. (Appendix 8) The Standards for Marketing Approval of Ophthalmic Medicines
  886. EMEA-002185-PIP02-17 - paediatric investigation plan
  887. Teriparatide injection 600mcg/2.4 mL (r-DNA origin)
  888. Substance, product, organisation and referential (SPOR) master data
  889. EU/3/19/2209 - orphan designation for prevention of haemolytic disease of the foetus and…
  890. ema-comtessComtess
  891. PSUSA/00010442/201701 - periodic safety update report single assessment
  892. EMEA-002631-PIP01-19-M02 - paediatric investigation plan
  893. PSUSA/00001244/202204 - periodic safety update report single assessment
  894. 18th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
  895. PSUSA/00002201/202306 - periodic safety update report single assessment
  896. Management Board meeting: 21 March 2024
  897. EMEA-000991-PIP01-10 - paediatric investigation plan
  898. Details of clinical trial Permissions of Year 2022
  899. FDA Paper Shows how Agency Will Regulate AI
  900. ema-orepaxamOrepaxam
  901. PSUSA/00002355/201808 - periodic safety update report single assessment
  902. 21 CFR 1.614: What quality assurance procedures must an accreditation body have to qualify…
  903. Mary Logan: Welcome to the New AAMIBlog!
  904. EU/3/09/613 - orphan designation for treatment of Pseudomonas aeruginosa lung infection in…
  905. In-use stability testing of human medicinal products - Scientific guideline
  906. cdsco-fluconazole-marioFluconazole (MARIO)
  907. 21 CFR 882.1310: Cortical electrode.
  908. Committee for Orphan Medicinal Products: January 2006 meeting
  909. ema-zevalinZevalin
  910. Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor…
  911. CMDh endorses restricted use of bromocriptine for stopping breast milk production
  912. ema-incident-management-planIncident management plan
  913. Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 January…
  914. National Adverse Events Following Immunisation (AEFI) reporting form
  915. European Medicines Agency website unavailable Saturday 11 June 2016
  916. Public Statement on Ziagen (Abacavir) - Important safety Information on Hypersensitivity…
  917. hsa-form-3Form 3
  918. Fourteenth Meeting of the Management Board
  919. EU/3/10/829 - orphan designation for treatment of gastric cancer
  920. 2019.03.08 Final G.S.R. 205(E) Omission of provision for writing brand name in brackets in…
  921. HHS Proposes Rule to Ding Health Care Providers Who Block Electronic Health Record Data
  922. cdsco-as012AS012
  923. FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium…
  924. 21 CFR 884.4160: Unipolar endoscopic coagulator-cutter and accessories.
  925. Dabigatran etexilate dual
  926. Webinar for industry and contract research organisations (CROs) on revised Environmental…
  927. 21 CFR 870.3640: Indirect pacemaker generator function analyzer.
  928. ema-rekambysRekambys
  929. NOC update list of Medical Devices 2013
  930. ema-clopidogrel-acino-pharmaClopidogrel Acino Pharma
  931. Refusal of orphan designation for treatment of non-small cell lung cancer (NSCLC) that is…
  932. Workshop on methods for efficacy studies in everyday medical practice
  933. ema-silgardSilgard
  934. 21 CFR 2.19: Methods of analysis.
  935. EU/3/05/274 - orphan designation for treatment of non-24-hour sleep-wake disorders in…
  936. 21 CFR 872.4565: Dental hand instrument.
  937. EU/3/19/2141 - orphan designation for treatment of haemophilia B
  938. EU/3/18/2042 - orphan designation for treatment of achromatopsia
  939. Sucroferic oxyhydroxide
  940. cdsco-saruparib-azd5305-20mgSaruparib (AZD5305) 20mg
  941. EMEA-000724-PIP02-11 - paediatric investigation plan
  942. Notice regaring submission of documents in scan copy
  943. EMEA-002442-PIP01-18 - paediatric investigation plan
  944. Capacitor
  945. Improving understanding of biosimilars in the EU
  946. 21 CFR 82.101: FD&C Blue No. 1.
  947. Assessment templates updated to include information on geriatric studies and new active…
  948. 21 CFR 50.53: Clinical investigations involving greater than minimal risk and no prospect…
  949. cfr-21-cfr-13-1-scope21 CFR 13.1: Scope.
  950. Drug Alert list for month of August 2020
  951. ema-open-consultationsOpen consultations
  952. EU/3/17/1837 - orphan designation for treatment of myelodysplastic syndromes
  953. 21 CFR 866.3700: Staphylococcus aureus serological reagents.
  954. EMEA-001405-PIP01-12 - paediatric investigation plan
  955. ACT EU multi-stakeholder platform kick-off workshop
  956. EMEA-000279-PIP01-08-M05 - paediatric investigation plan
  957. Levonelle 1500 microgram tablets and associated names - referral
  958. cfr-21-cfr-73-500-saffron21 CFR 73.500: Saffron.
  959. EMEA-002578-PIP01-19 - paediatric investigation plan
  960. Innovation in veterinary medicines
  961. 21 CFR 7.53: Recall status reports.
  962. MK-7684 with Pembrolizumab
  963. Progress in science, medicines, health
  964. Guidance 18: Impurities in drug substances and drug products
  965. PIC/S GMP Guide (PE 009-17) Introduction
  966. EU/3/20/2261 - orphan designation for treatment of chronic myeloid leukaemia
  967. AAMI’s BMET Apprenticeship Program is Here to Stay. Are You Involved Yet?
  968. PSUSA/00010800/202311 - periodic safety update report single assessment
  969. List of meetings of Expert Committee for examination of vaccine PSUR 2023-24
  970. EMA regular press briefing on COVID-19
  971. cdsco-azd5305AZD5305
  972. Is Your CMMS Ready to Be Your ‘Source of Truth’?
  973. EU/3/03/164 - orphan designation for treatment of cocaine poisoning
  974. Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs
  975. 21 CFR 868.5440: Portable oxygen generator.
  976. NOTICE - regarding availability of essential mediines following implementation of GST
  977. FDA CDRH Rolls Out “TAP Pilot,” Total Life Cycle Program for Medical Devices
  978. 21 CFR 82.1306: D&C Red No. 6.
  979. EMEA-002542-PIP02-19 - paediatric investigation plan
  980. cdsco-rabi-767RABI 767
  981. Update on nitrosamines in EU medicines
  982. EU/3/16/1756 - orphan designation for treatment of cutaneous T-cell lymphoma
  983. EMEA-002580-PIP01-19 - paediatric investigation plan
  984. Dronedarone product-specific bioequivalence guidance
  985. European Union Committee of Experts on Rare Diseases/European Medicines Agency workshop…
  986. Comments invited on concept paper on the need to revise the guideline on medicines to…
  987. Committee for veterinary medicinal products: 61st meeting
  988. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19…
  989. Regulatory information – new formatted table template to be used in selected veterinary…
  990. ema-mephatrim-referralMephatrim - referral
  991. Symphyti radix - herbal medicinal product
  992. EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory…
  993. Ivermectin topical lotion 0.5% w/w
  994. Guidance on mushroom products
  995. PSUSA/00010364/201603 - periodic safety update report single assessment
  996. EMEA-002180-PIP02-19 - paediatric investigation plan

About this dataset

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

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