Topics tagged FDA

Topic	Replies	Views	Activity
Impact of Antioxidant Excipients on N-nitrosamine Formation and Bioequivalence in Metformin Formulations - Pub New Scientific Knowledge & Development risk-assessment , Excipients , FDA	3	475	February 11, 2025
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2 Guidance, Documents, Resources FDA	46	3211	January 18, 2025
CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2 Guidance, Documents, Resources FDA	1	355	January 2, 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	35	2959	December 3, 2024
Requirement after reformulation of existing approved drug product for Europe New Scientific Knowledge & Development EMA , FDA	12	368	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	431	October 2, 2024
FDA-CDER and HESI \| Nitrosamine Ames Data Review and Method Development Workshop Events / Workshops / Webinars FDA	1	253	September 17, 2024
🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3 Limits of Nitrosamines Limits , FDA , NDSRI	16	3733	July 28, 2024
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines Nitrosamines in the News FDA , NDSRI	3	1168	July 21, 2023
AI Limit for Nitroso Nebivolol Limits of Nitrosamines FDA , Drug_Substance_APIs , Storage_Stability , Manufacturing , Live-Conversations	11	2712	April 3, 2024
CDER Drug Safety Priorities Fiscal Year 2023 Guidance, Documents, Resources FDA	1	586	February 16, 2024
Nitrosamine requirements for probiotics Guidance, Documents, Resources FDA	4	356	February 12, 2024
N-nitroso Vonoprazan AI 96 ng/day- FDA Limits of Nitrosamines FDA	5	3404	January 29, 2024
A quick (dumb) question Limits of Nitrosamines FDA , Excipients	10	1151	January 22, 2024
US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2024 Nitrosamines in the News FDA	0	436	January 18, 2024
AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position? Limits of Nitrosamines Limits , FDA , NDSRI	2	649	November 9, 2023
N-Nitroso desmethyl bedaquiline Limits of Nitrosamines FDA	0	656	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	677	August 14, 2023
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities Events / Workshops / Webinars Excipients , FDA , NDSRI , Drug_Substance_APIs , Manufacturing	11	3626	July 27, 2023
Fiscal Year (FY) 2023 Generic Drug Science and Research Initiatives Public Workshop May 11-12, 2023 Events / Workshops / Webinars FDA	3	626	June 15, 2023
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals Limits of Nitrosamines NDSRI , ames , FDA , Drug_Substance_APIs	2	922	June 5, 2023
N-nitroso Des-methyl Dapoxetine Limits of Nitrosamines FDA , Manufacturing , Drug_Substance_APIs	12	1220	May 31, 2023
FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays Limits of Nitrosamines FDA , NDSRI , ames , NDSRIs	1	1533	May 24, 2023
Florida District Court dismissed claims that "Ranitidine-NDMA caused cancer -" because of "unreliable methodologies" and lacked "science-based standards" Nitrosamines in the News FDA	0	360	December 13, 2022
Harmonization of AI for NDSRIs with insufficient carcinogenic data Limits of Nitrosamines FDA	5	1097	July 14, 2022
FDA - Generic Drug Forum 2022 (Nitrosamine update) 📺 Events / Workshops / Webinars FDA	9	1064	April 27, 2022