๐บ๐ธ FDA Control of Nitrosamine Impurities in Human Drugs revision2
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54
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4170
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May 4, 2025
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๐
Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities (NDSRIs) and Bioequivalence Assessment for Reformulated Drug Products(CRCG)
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39
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3257
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May 2, 2025
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US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2024
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1
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494
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May 1, 2025
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๐ต๐ป OTC Market Withdrawal of Diphenhydramine
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0
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228
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April 24, 2025
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FDA Generic Drugs Forum - Bioequivalence Approaches
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2
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459
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April 22, 2025
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N-nitroso-esmolol
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0
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81
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April 22, 2025
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Generic Drugs Forum (GDF) 2025
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5
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832
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April 19, 2025
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:brazil: Lhasa Brazil Symposium: Aligning Pharma & Regulatory Standards Globally :brazil:
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0
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118
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April 3, 2025
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US FDA declines to approve Milestone's heart rhythm nasal spray; shares halve
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0
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164
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March 28, 2025
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CDER Drug Safety Priorities Fiscal Year 2023
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2
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646
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February 27, 2025
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Impact of Antioxidant Excipients on N-nitrosamine Formation and Bioequivalence in Metformin Formulations - Pub
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3
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571
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February 11, 2025
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๐จโ๐ป FDA-CRCG NDSRI Workshop
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2
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1455
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January 10, 2025
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CHPA's response to the Control of Nitrosamine Impurities in Human Drugs rev.2
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1
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378
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January 2, 2025
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Requirement after reformulation of existing approved drug product for Europe
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12
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386
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November 12, 2024
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Aptarโs N-Sorb Nitrosamine Mitigation Solution Accepted to US FDAโs Emerging Technology Program
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6
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457
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October 2, 2024
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FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop
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1
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264
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September 17, 2024
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๐บ๐ธ FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
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16
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3878
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July 28, 2024
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Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
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3
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1172
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July 21, 2023
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AI Limit for Nitroso Nebivolol
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11
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2753
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April 3, 2024
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Nitrosamine requirements for probiotics
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4
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357
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February 12, 2024
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N-nitroso Vonoprazan AI 96 ng/day- FDA
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5
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3614
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January 29, 2024
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A quick (dumb) question
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10
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1198
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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
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660
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November 9, 2023
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N-Nitroso desmethyl bedaquiline
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0
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665
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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
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682
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August 14, 2023
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FDA Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities
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11
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3745
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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
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627
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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
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925
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June 5, 2023
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N-nitroso Des-methyl Dapoxetine
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12
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1245
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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
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1544
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May 24, 2023
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