Topics tagged FDA

Topic	Replies	Views	Activity
Another Prazosin recall linked to N-nitroso-prazosin impurity C raises renewed concern for the finished product Nitrosamines in the News FDA , NDSRI , recall	10	776	July 7, 2026
Nitrosamines: Mass Spectrometry-Based Analytical Procedures Criterias Confirmatory Testing & Analytical Challenges validation , FDA , confirmatory	11	4517	July 2, 2026
Regulatory Flexibilities and Clarifications: Chemistry, Manufacturing and Control (CMC) Information for Original First in Human (FIH) Phase 1 INDs Guidance, Documents, Resources FDA	2	308	June 25, 2026
Advancing Generic Drug Development: Translating Science to Approval 2025 Events / Workshops / Webinars FDA	3	522	June 11, 2026
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop Events / Workshops / Webinars FDA	6	356	June 8, 2026
FDA-CDER and HESI \| Nitrosamine Ames Data Review and Method Development Workshop Events / Workshops / Webinars FDA	2	402	May 6, 2026
Generic Drugs Forum (GDF) 2026 Events / Workshops / Webinars FDA	17	864	May 5, 2026
About the amlodipine nitrosamines N-nitrosamines Chemistry FDA	3	245	April 21, 2026
🇺🇸 FDA Workshop - Nitrosamine-driven Reformulation and Bioequivelance Events / Workshops / Webinars FDA , mitigation	1	256	April 17, 2026
FDA CRCG Workshop on Bioequivalence Innovations for Generic Oral Products Events / Workshops / Webinars FDA	0	115	April 11, 2026
Limit of Common or Small Nitrosamine Impurities in RSM irrespective of any particular MDD Limits of Nitrosamines small-nitrosamines , risk-assessment , Drug_Substance_APIs , FDA	9	412	January 21, 2026
Determination That ZANTAC (Ranitidine Hydrochloride) Injection, Equivalent to 25 Milligrams Base/Milliliter, Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness Nitrosamines in the News FDA	1	274	December 17, 2025
FDA Approves Reformulated Ranitidine - Nitrosamine Impurities - NDMA Nitrosamines in the News FDA , NDSRI , ICH-M7 , Drug_Substance_APIs , Storage_Stability	3	613	November 27, 2025
Nitrosamine Contamination in Pharmaceuticals: A Retrospective Regulatory Analysis of USFDA Recalls and Risk Mitigation Strategies (2018–2025)-Pub New Scientific Knowledge & Development FDA	0	250	November 18, 2025
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2 Guidance, Documents, Resources FDA	65	6474	October 3, 2025
US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2024 Nitrosamines in the News FDA	2	633	October 1, 2025
Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells -Pub New Scientific Knowledge & Development FDA , NDSRI	0	278	July 12, 2025
🚨 FDA deadline update Guidance, Documents, Resources FDA , deadlines	14	1404	August 7, 2025
AI limit for 1-Nitrosopiperazine Limits of Nitrosamines AI , EMA , FDA	8	762	June 4, 2025
📅 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products(CRCG) Events / Workshops / Webinars NDSRI , FDA	39	3707	May 2, 2025
🕵🏻 OTC Market Withdrawal of Diphenhydramine Nitrosamines in the News NDSRI , FDA	0	719	April 24, 2025
FDA Generic Drugs Forum - Bioequivalence Approaches Events / Workshops / Webinars FDA , featured	2	1144	April 22, 2025
N-nitroso-esmolol Limits of Nitrosamines NDSRI , FDA	0	235	April 22, 2025
Generic Drugs Forum (GDF) 2025 Events / Workshops / Webinars FDA	5	1112	April 19, 2025
:brazil: Lhasa Brazil Symposium: Aligning Pharma & Regulatory Standards Globally :brazil: Events / Workshops / Webinars risk-assessment , FDA , NDSRI	0	164	April 3, 2025
US FDA declines to approve Milestone's heart rhythm nasal spray; shares halve Nitrosamines in the News FDA	0	250	March 28, 2025
CDER Drug Safety Priorities Fiscal Year 2023 Guidance, Documents, Resources FDA	2	715	February 27, 2025
Impact of Antioxidant Excipients on N-nitrosamine Formation and Bioequivalence in Metformin Formulations - Pub New Scientific Knowledge & Development risk-assessment , Excipients , FDA	3	829	February 11, 2025
👨‍💻 FDA-CRCG NDSRI Workshop Events / Workshops / Webinars FDA , CRCG	2	1601	January 10, 2025
CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2 Guidance, Documents, Resources FDA	1	440	January 2, 2025