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AI Limit for Nitroso Nebivolol
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11
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2910
|
April 3, 2024
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Nitrosamine requirements for probiotics
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4
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372
|
February 12, 2024
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N-nitroso Vonoprazan AI 96 ng/day- FDA
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5
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4203
|
January 29, 2024
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A quick (dumb) question
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10
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1418
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January 22, 2024
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AI for NDSRIs with positive EAT and/or in-vivo mutagenicity study - FDA position?
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2
|
708
|
November 9, 2023
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N-Nitroso desmethyl bedaquiline
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0
|
697
|
October 6, 2023
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Total impurities limit if more than one nitrosamine impurities are observed in product
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4
|
721
|
August 14, 2023
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FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
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11
|
4037
|
July 27, 2023
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Fiscal Year (FY) 2023 Generic Drug Science and Research Initiatives Public Workshop May 11-12, 2023
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3
|
641
|
June 15, 2023
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FDA/HESI Collaborative Roadmap: Advancing Hazard and Risk Assessment of Nitrosamine Impurities in Pharmaceuticals
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2
|
953
|
June 5, 2023
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N-nitroso Des-methyl Dapoxetine
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12
|
1332
|
May 31, 2023
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FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
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1
|
1600
|
May 24, 2023
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Florida District Court dismissed claims that "Ranitidine-NDMA caused cancer -" because of "unreliable methodologies" and lacked "science-based standards"
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0
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369
|
December 13, 2022
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Harmonization of AI for NDSRIs with insufficient carcinogenic data
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5
|
1128
|
July 14, 2022
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FDA - Generic Drug Forum 2022 (Nitrosamine update) 📺
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9
|
1116
|
April 27, 2022
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