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About the Guidance, Documents, Resources category
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0
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206
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April 14, 2021
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EMA Q&A Appendix 1 update posted Sept 28,2023
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0
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11
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September 28, 2023
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Autonomous Carcinogenic Potency Categorization Approach for Nitrosamine Drug Substance-related Impurities
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16
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304
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September 27, 2023
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🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
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47
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2756
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September 20, 2023
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WHO on Nitrosamines, Rifampicin, Rifapentine and NDSRIS
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3
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205
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September 20, 2023
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🇪🇺 EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
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108
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6571
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September 12, 2023
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Fifth Nitrosamine Implementation Oversight Group (NIOG) – meeting with pharmaceutical industry
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1
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295
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September 6, 2023
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🇬🇧 MHRA publishes guidelines for Nitrosamine Impurities
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4
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561
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August 28, 2023
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Q&A revision 17 uploaded on EMA page
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12
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882
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August 25, 2023
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IPA-QF Guidance on Nitrosamines Impurities
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0
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450
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August 18, 2023
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CPCA is now included in the updated version of Health Canada’s Guidance on nitrosamine impurities
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12
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651
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August 16, 2023
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Measuring Nitrites in headspace
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4
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271
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August 15, 2023
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🇺🇸 FDA Recommended AI Limits for Certain Hypothetical NDSRIs
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0
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533
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August 8, 2023
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Planilha CPCA na prática
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0
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146
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August 6, 2023
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The Nitrosamine “Saga”
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3
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627
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July 29, 2023
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N Nitroso Vildagliptin amide
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2
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256
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July 25, 2023
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Nitrosamine Guidance for Cream and Ophthalmic Solutions
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3
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222
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July 24, 2023
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NDSRIs: Atualizações e Desafios
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0
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189
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July 24, 2023
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Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations
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9
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336
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July 21, 2023
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FDA - Notice on Chantix
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3
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422
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July 20, 2023
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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0
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356
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July 18, 2023
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Establishment of Acceptable Intakes, framework
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12
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361
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July 12, 2023
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New Guidance from Malaysia's NPRA 03 July 2023
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0
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329
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July 12, 2023
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What method accuracy criteria to be considered for nitrosamines, which guidance mentioned accuracy criteria?
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2
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307
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July 10, 2023
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Losartan azide impurity confirmed as not an in vivo mutagen compound
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5
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724
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June 20, 2023
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Guideline ANVISA - Brazil: version 3, updates
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8
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1276
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June 19, 2023
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FDA solicit comments on assessment of NDSRIs
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12
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1443
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July 11, 2023
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Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs
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4
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324
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June 9, 2023
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The predecesor to ICH M7
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0
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333
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June 7, 2023
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Secondary amine Risk Assessment
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9
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636
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June 1, 2023
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