Topics tagged FDA

Topic	Replies	Views	Activity
🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2 Guidance, Documents, Resources FDA	38	2561	December 9, 2024
📅 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	2780	December 3, 2024
Requirement after reformulation of existing approved drug product for Europe New Scientific Knowledge & Development EMA , FDA	12	348	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	413	October 2, 2024
FDA-CDER and HESI \| Nitrosamine Ames Data Review and Method Development Workshop Events / Workshops / Webinars FDA	1	235	September 17, 2024
🇺🇸 FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3 Limits of Nitrosamines Limits , FDA , NDSRI	16	3599	July 28, 2024
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines Nitrosamines in the News FDA , NDSRI	5	1167	July 20, 2024
AI Limit for Nitroso Nebivolol Limits of Nitrosamines FDA , Drug_Substance_APIs , Storage_Stability , Manufacturing , Live-Conversations	11	2655	April 3, 2024
CDER Drug Safety Priorities Fiscal Year 2023 Guidance, Documents, Resources FDA	1	582	February 16, 2024
Nitrosamine requirements for probiotics Guidance, Documents, Resources FDA	4	352	February 12, 2024
N-nitroso Vonoprazan AI 96 ng/day- FDA Limits of Nitrosamines FDA	5	3244	January 29, 2024
A quick (dumb) question Limits of Nitrosamines FDA , Excipients	10	1124	January 22, 2024
US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2024 Nitrosamines in the News FDA	0	434	January 18, 2024
AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position? Limits of Nitrosamines Limits , FDA , NDSRI	2	643	November 9, 2023
N-Nitroso desmethyl bedaquiline Limits of Nitrosamines FDA	0	652	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	674	August 14, 2023
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities Events / Workshops / Webinars Excipients , FDA , NDSRI , Drug_Substance_APIs , Manufacturing	11	3576	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	916	June 5, 2023
N-nitroso Des-methyl Dapoxetine Limits of Nitrosamines FDA , Manufacturing , Drug_Substance_APIs	12	1199	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	1524	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	1090	July 14, 2022
FDA - Generic Drug Forum 2022 (Nitrosamine update) 📺 Events / Workshops / Webinars FDA	9	1052	April 27, 2022