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0
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187
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July 12, 2025
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π¨ FDA deadline update
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13
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923
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June 30, 2025
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πΊπΈ FDA Control of Nitrosamine Impurities in Human Drugs revision2
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61
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4980
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June 14, 2025
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AI limit for 1-Nitrosopiperazine
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8
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305
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June 4, 2025
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π
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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3353
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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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500
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May 1, 2025
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π΅π» OTC Market Withdrawal of Diphenhydramine
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0
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387
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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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647
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April 22, 2025
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N-nitroso-esmolol
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0
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106
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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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910
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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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130
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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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173
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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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648
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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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612
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February 11, 2025
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π¨βπ» FDA-CRCG NDSRI Workshop
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2
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1499
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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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387
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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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407
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November 12, 2024
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Aptarβs N-Sorb Nitrosamine Mitigation Solution Accepted to US FDAβs Emerging Technology Program
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6
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497
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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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269
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September 17, 2024
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πΊπΈ FDA - Updated information on recommended AI for NDSRIs (23/Feb/2024) - Tables 2 & 3
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16
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4009
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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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1178
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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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2780
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April 3, 2024
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Nitrosamine requirements for probiotics
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4
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359
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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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3810
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January 29, 2024
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A quick (dumb) question
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10
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1276
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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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675
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November 9, 2023
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N-Nitroso desmethyl bedaquiline
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0
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669
|
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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693
|
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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3832
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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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