Topics tagged FDA

Topic	Replies	Views	Activity
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2 Guidance, Documents, Resources FDA	64	5322	August 6, 2025
Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cells -Pub New Scientific Knowledge & Development FDA , NDSRI	0	235	July 12, 2025
🚨 FDA deadline update Guidance, Documents, Resources FDA , deadlines	14	1072	August 7, 2025
AI limit for 1-Nitrosopiperazine Limits of Nitrosamines AI , EMA , FDA	8	359	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	3378	May 2, 2025
US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2024 Nitrosamines in the News FDA	1	503	May 1, 2025
🕵🏻 OTC Market Withdrawal of Diphenhydramine Nitrosamines in the News NDSRI , FDA	0	424	April 24, 2025
FDA Generic Drugs Forum - Bioequivalence Approaches Events / Workshops / Webinars FDA , featured	2	713	April 22, 2025
N-nitroso-esmolol Limits of Nitrosamines NDSRI , FDA	0	122	April 22, 2025
Generic Drugs Forum (GDF) 2025 Events / Workshops / Webinars FDA	5	930	April 19, 2025
:brazil: Lhasa Brazil Symposium: Aligning Pharma & Regulatory Standards Globally :brazil: Events / Workshops / Webinars risk-assessment , FDA , NDSRI	0	132	April 3, 2025
US FDA declines to approve Milestone's heart rhythm nasal spray; shares halve Nitrosamines in the News FDA	0	175	March 28, 2025
CDER Drug Safety Priorities Fiscal Year 2023 Guidance, Documents, Resources FDA	2	648	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	627	February 11, 2025
👨‍💻 FDA-CRCG NDSRI Workshop Events / Workshops / Webinars FDA , CRCG	2	1508	January 10, 2025
CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2 Guidance, Documents, Resources FDA	1	389	January 2, 2025
Requirement after reformulation of existing approved drug product for Europe New Scientific Knowledge & Development EMA , FDA	12	416	November 12, 2024
Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program New Scientific Knowledge & Development Packaging , FDA	6	507	October 2, 2024
FDA-CDER and HESI \| Nitrosamine Ames Data Review and Method Development Workshop Events / Workshops / Webinars FDA	1	270	September 17, 2024
🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3 Limits of Nitrosamines Limits , FDA , NDSRI	16	4054	July 28, 2024
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines Nitrosamines in the News FDA , NDSRI	3	1179	July 21, 2023
AI Limit for Nitroso Nebivolol Limits of Nitrosamines FDA , Drug_Substance_APIs , Storage_Stability , Manufacturing , Live-Conversations	11	2800	April 3, 2024
Nitrosamine requirements for probiotics Guidance, Documents, Resources FDA	4	359	February 12, 2024
N-nitroso Vonoprazan AI 96 ng/day- FDA Limits of Nitrosamines FDA	5	3885	January 29, 2024
A quick (dumb) question Limits of Nitrosamines FDA , Excipients	10	1287	January 22, 2024
AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position? Limits of Nitrosamines Limits , FDA , NDSRI	2	677	November 9, 2023
N-Nitroso desmethyl bedaquiline Limits of Nitrosamines FDA	0	671	October 6, 2023
Total impurities limit if more than one nitrosamine impurities are observed in product Limits of Nitrosamines Manufacturing , NDSRI , Drug_Substance_APIs , FDA , Live-Conversations	4	694	August 14, 2023
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities Events / Workshops / Webinars Excipients , FDA , NDSRI , Drug_Substance_APIs , Manufacturing	11	3857	July 27, 2023
Fiscal Year (FY) 2023 Generic Drug Science and Research Initiatives Public Workshop May 11-12, 2023 Events / Workshops / Webinars FDA	3	627	June 15, 2023