Topics tagged FDA

Topic	Replies	Views	Activity
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	249	August 14, 2023
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities Events / Workshops / Webinars Excipients , FDA , NDSRI , Drug_Substance_APIs , Manufacturing	11	1413	July 27, 2023
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines Nitrosamines in the News FDA , NDSRI	3	458	July 21, 2023
Fiscal Year (FY) 2023 Generic Drug Science and Research Initiatives Public Workshop May 11-12, 2023 Events / Workshops / Webinars FDA	3	321	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	413	June 5, 2023
N-nitroso Des-methyl Dapoxetine Limits of Nitrosamines FDA , Manufacturing , Drug_Substance_APIs	12	502	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	959	May 24, 2023
N-nitroso Vonoprazan AI 96 ng/day- FDA Limits of Nitrosamines FDA	1	626	January 5, 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	150	December 13, 2022
AI Limit for Nitroso Nebivolol Limits of Nitrosamines FDA , Drug_Substance_APIs , Storage_Stability , Manufacturing , Live-Conversations	8	1089	October 6, 2022
Harmonization of AI for NDSRIs with insufficient carcinogenic data Limits of Nitrosamines FDA	5	594	July 14, 2022
FDA - Generic Drug Forum 2022 (Nitrosamine update) 📺 Events / Workshops / Webinars FDA	9	571	April 27, 2022