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About the Guidance, Documents, Resources category
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0
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630
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April 14, 2021
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Requirements for NAs assessment in Russia
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2
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66
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June 10, 2026
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Upcoming EMA Q&A for other nitrosocompounds
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3
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370
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June 5, 2026
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An updated version of Health Canada's Guidance on nitrosamine impurities in medications(Update May 29, 2026)
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0
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209
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June 2, 2026
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Analysis of Nitrite in Pharmaceutical Excipients: A Multi‑Laboratory Comparative Study - PUB
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3
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412
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June 1, 2026
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🇰🇷 MFDS Guideline: Compilation of Analysis Methods on the Determination of Impurities in Pharmaceuticals, May-2026
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2
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254
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May 19, 2026
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Mutagenic Impurities in USP -future looking
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16
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1373
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May 14, 2026
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N-Nitroso Mefanaminc Acid
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1
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143
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May 12, 2026
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N-Nitroso dially amine estimation by LCMS
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2
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89
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April 29, 2026
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Regulatory Flexibilities and Clarifications: Chemistry, Manufacturing and Control (CMC) Information for Original First in Human (FIH) Phase 1 INDs
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0
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195
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April 23, 2026
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🇲🇽 Mexico Nitrosamine Guide published today
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46
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3688
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January 16, 2026
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Nitrosamine impurity evaluation in animal health API
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2
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112
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January 15, 2026
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Evaluation of Nitrosamine impurities in animal health APIs
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1
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147
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January 8, 2026
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Liquid medicinal product with lidocaine
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4
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193
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January 8, 2026
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Nitrosamine impurities in animal health APIs
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1
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185
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December 24, 2025
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Establishing Best Practice for N- Nitrosamine Read-Across and Surrogate Selection
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0
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170
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December 22, 2025
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🇪🇬 Egypt (EDA) Public Consultation regarding the Guidelines for Nitrosamine Impurities
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0
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116
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November 19, 2025
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EMA - nitrosamines Leading Member State (LMS)
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2
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336
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November 13, 2025
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N-nitrosamine occurrence in disinfected drinking water
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0
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255
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November 5, 2025
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🖥 Nitrosamines risk from Water for Pharmaceutical Purpose according to USP
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2
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986
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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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267
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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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684
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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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422
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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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2665
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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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270
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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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6231
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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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190
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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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374
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August 25, 2025
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Nitrite testing in Excipients
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2
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608
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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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739
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August 3, 2025
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