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About the Guidance, Documents, Resources category
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0
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551
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April 14, 2021
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🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
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50
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3580
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March 20, 2025
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Acceptance criteria for Nitrosamines Method Validation
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3
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288
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March 14, 2025
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CDER Drug Safety Priorities Fiscal Year 2023
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2
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643
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February 27, 2025
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Adjustment of the MDD with CYP inducers?
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2
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147
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February 13, 2025
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EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024
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8
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1506
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January 27, 2025
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ICH M7 & Nitrosamines Impurities -Updates
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15
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3501
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January 20, 2025
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Control Strategy - Testing Frequency
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10
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370
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January 20, 2025
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🇲🇽 Mexico Q&A Live session streaming
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7
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644
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January 6, 2025
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Critical comparison of BMD and TD50 methods for the calculation of acceptable intakes for N-nitroso compounds -Pub
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0
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258
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January 3, 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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371
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January 2, 2025
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AI for pharmaceutical legislation, including nitrosamines
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4
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340
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December 30, 2024
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WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products
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4
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1124
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December 21, 2024
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Autonomous CPCA Web-based calculator FREE
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31
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5632
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December 12, 2024
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Nitrosamine Mitigation: A Path to Regulatory Compliance
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0
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308
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November 22, 2024
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🇲🇽 Mexico Nitrosamine Guide published today
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42
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2724
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November 22, 2024
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Methylene Blue NDSRI
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6
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503
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November 22, 2024
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New EMA Nitrosamine impurities page
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0
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401
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November 21, 2024
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Terbinafine Nitrosamines
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3
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178
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November 14, 2024
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NDSRI limit for N-nitroso Ciprofloxacin
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2
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261
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November 1, 2024
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FDA Statement on Ritonavir and NITMA
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1
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277
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October 29, 2024
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Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
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7
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522
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October 29, 2024
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N-Nitrosamine drug substance related impurities (NDSRIs) – A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da -Pub
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0
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244
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October 28, 2024
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Nitroso Betahistine Impurity C
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2
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130
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October 28, 2024
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Use of L-cysteine as nitrite scavenging
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6
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254
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October 25, 2024
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Selection of Solvent and Positive Control Concentration for Enhanced AMES Test -Pub
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0
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106
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October 14, 2024
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Oral Liquid Formulations
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4
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187
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October 14, 2024
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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5
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1703
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October 9, 2024
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Dietary exposure assessment for volatile N-nitrosamines from food and beverages for the U.S. population -Pub
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0
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114
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September 18, 2024
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NDMA testing in metformin
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5
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220
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September 9, 2024
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