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About the Guidance, Documents, Resources category
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0
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595
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April 14, 2021
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🖥 Nitrosamines risk from Water for Pharmaceutical Purpose according to USP
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2
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724
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October 24, 2025
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IPEC Excipient new questionnaire, October 2025
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2
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128
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October 23, 2025
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Updated: IPEC Questionnaire for Excipient Nitrosamines Risk Evaluation
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2
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310
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October 23, 2025
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Understanding nitrosamine risk in listed medicines
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2
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299
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October 14, 2025
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EMA Q&A Rev. 22 (EMA/409815/2020 Rev.22)
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5
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1587
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October 10, 2025
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🇺🇸 US FDA- Generic Drug Science and Research Priority Initiatives for Fiscal Year (FY) 2026
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0
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215
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October 6, 2025
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🇺🇸 FDA Control of Nitrosamine Impurities in Human Drugs revision2
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65
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5645
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October 3, 2025
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🇲🇽 Mexico Nitrosamine Guide published today
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44
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3155
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October 3, 2025
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Quantitative genotoxicity assessment of N-nitrosodimethylamine in mice by error-corrected next-generation sequencing and DNA methylation quantification for toxicity threshold determination
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2
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135
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September 24, 2025
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Computational Mechanistic Study on N-Nitrosation Reaction of Secondary Amines
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0
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349
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August 25, 2025
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Nitrite testing in Excipients
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2
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451
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August 17, 2025
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:canada: Health Canada Extended Deadline
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5
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616
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August 3, 2025
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Nitrosamine impurities in human medicines/ European Medicines Regulatory Network
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0
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328
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July 29, 2025
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Nitrosamine Control Strategies: From Risk Identification to Implementation
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3
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382
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July 24, 2025
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N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025?
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0
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333
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July 24, 2025
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Highlights from the 13th meeting of the Nitrosamine Implementation Oversight Group (NIOG)
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7
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481
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July 22, 2025
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Analytical Procedures and Validation_Specificity parameter requirment
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9
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501
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July 9, 2025
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Addendum to ICH M7 on Risk Assessment and Control of N-Nitrosamine Impurities
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8
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1857
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July 3, 2025
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🚨 FDA deadline update
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14
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1168
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August 7, 2025
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Cleaning procedure for glassware used in the analysis of nitrosamines for LC-MS/MS
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2
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360
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May 23, 2025
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Nitrosamine Mitigation: A Path to Regulatory Compliance
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1
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461
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May 11, 2025
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Nitrosourea, aromatic n-nitroso copmounds
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2
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224
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May 2, 2025
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Autonomous CPCA Web-based calculator FREE
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33
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6405
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April 30, 2025
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Annex 2 WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products
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0
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407
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April 16, 2025
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Nitrosamines Safety Operational Expert Group
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0
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135
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April 16, 2025
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Clobam Nitrosamine Impurity
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0
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131
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April 8, 2025
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Acceptance criteria for Nitrosamines Method Validation
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3
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430
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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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648
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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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156
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February 13, 2025
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