Total impurities limit if more than one nitrosamine impurities are observed in product
|
|
4
|
249
|
August 14, 2023
|
FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
|
|
11
|
1413
|
July 27, 2023
|
Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
|
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3
|
458
|
July 21, 2023
|
Fiscal Year (FY) 2023 Generic Drug Science and Research Initiatives Public Workshop May 11-12, 2023
|
|
3
|
321
|
June 15, 2023
|
FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals
|
|
2
|
413
|
June 5, 2023
|
N-nitroso Des-methyl Dapoxetine
|
|
12
|
502
|
May 31, 2023
|
FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
|
|
1
|
959
|
May 24, 2023
|
N-nitroso Vonoprazan AI 96 ng/day- 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"
|
|
0
|
150
|
December 13, 2022
|
AI Limit for Nitroso Nebivolol
|
|
8
|
1089
|
October 6, 2022
|
Harmonization of AI for NDSRIs with insufficient carcinogenic data
|
|
5
|
594
|
July 14, 2022
|
FDA - Generic Drug Forum 2022 (Nitrosamine update) 📺
|
|
9
|
571
|
April 27, 2022
|