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About the Guidance, Documents, Resources category
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0
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388
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April 14, 2021
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Autonomous CPCA Web-based calculator FREE
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28
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3406
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May 2, 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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3
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697
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April 24, 2024
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🇸🇦 Saudi FDA requesting Nitrosamines Risk Assessments
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2
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979
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April 17, 2024
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🇪🇺 EDQM - Certification of suitability to Monographs of the European Pharmacopoeia
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1
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292
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April 12, 2024
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EMA - Update Appendix 3: Enhanced Ames Test conditions for N-nitrosamines
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8
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841
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April 2, 2024
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🇪🇺 EDQM - top 10 deficiencies observed in new CEP applications
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0
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491
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March 14, 2024
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USP-NF General Notices Revision open for Comments
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0
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610
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March 7, 2024
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Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
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3
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636
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March 7, 2024
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CDER Drug Safety Priorities Fiscal Year 2023
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1
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361
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February 16, 2024
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New ICH Guideline Q14
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0
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320
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February 12, 2024
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Nitrosamine requirements for probiotics
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4
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180
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February 12, 2024
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Top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023
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1
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456
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February 9, 2024
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Notifying FDA of a Discontinuance or Interruption in Manufacturing
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0
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166
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February 7, 2024
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Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
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2
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211
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February 1, 2024
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🇪🇺 EMA/409815/2020 Rev.20
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7
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2104
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January 31, 2024
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Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
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4
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468
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January 30, 2024
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🇬🇧 Medicines: MAH' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
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2
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751
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January 23, 2024
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European Pharmacopeia - Open for comments 'N-Nitrosamines in active substance and medicinal products'
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0
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578
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December 19, 2023
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Health Canada updates guidance(incorrect post)
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2
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387
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January 14, 2024
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EDQM - European Pharmacopeia - Feedback Nitrosamines
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3
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830
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January 12, 2024
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N Nitroso Vildagliptin amide
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4
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1018
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December 18, 2023
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APIC NA Risk Assessment Template
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4
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1925
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December 13, 2023
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🇰🇷 Korea Drug Review Briefing session on Nitrosamines
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0
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337
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December 12, 2023
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NDSRI/ Guidance
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2
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350
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December 12, 2023
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Deadline for reporting changes
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2
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397
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December 5, 2023
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EMA Q&A Appendix 1 update posted Sept 28,2023
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13
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1488
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November 22, 2023
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🇨🇭 Swiss Medic Guidelines
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7
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1313
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November 20, 2023
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🇪🇺 EMA - Enhanced AMES test conditions
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0
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549
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November 15, 2023
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EMA Q&A Rev. 19 (EMA/409815/2020 Rev.19)
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0
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1362
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November 13, 2023
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