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South African Health Products Regulatory Authority (Nitrosamines)
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2
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688
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August 5, 2024
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👨💻 Dashboard Containing Published AI Limits
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32
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3522
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August 2, 2024
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🇲🇽 Coming July Mexico Nitrosamines Guideline
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5
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465
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August 2, 2024
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Extension of the implementation deadline for "Self-inspection on Risks of Contamination with Nitrosamines in Drug" in Japan
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2
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167
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July 30, 2024
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The clinical and regulatory status of NDSRI: A global imperative -Pub
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1
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244
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July 30, 2024
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EMA/CHMP Concept paper on the revision of the guideline on the chemistry of active substances
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4
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590
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July 29, 2024
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Swissmedic updated requirements for dealing with potential nitrosamine impurities in medicinal products
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3
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509
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July 28, 2024
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Development and Manufacture of Oligonucleotides + Nitrosamines
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0
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258
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July 24, 2024
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🇪🇺 EMA/409815/2020 Rev.21 (19-Jul-24)
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1
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1636
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July 22, 2024
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ICH M7 plans to harmonize AI limits for Nitrosamines
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1
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292
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June 13, 2024
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Nitrosamines in food raise a health concern (EFSA)
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7
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1066
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June 11, 2024
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Update: EFPIA workflows for Quality Risk management Jun 2024 v03
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2
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723
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June 4, 2024
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🇰🇷 Case study on the Occurrence of Impurities in Pharmaceuticals (Focusing on NDMA Cases)
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0
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289
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May 31, 2024
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Justify the presence of amine in the API chemical structure
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3
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256
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May 29, 2024
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FDA releases FY23 GDUFA Science and Research Report
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0
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267
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May 24, 2024
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🇪🇺 EDQM - top 10 deficiencies observed in new CEP applications
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0
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925
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March 14, 2024
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An Organic Guide to N-Nitrosamines: Structure, Reactivity, and Role as Contaminants
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1
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507
|
May 13, 2024
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APIC NA Risk Assessment Template
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5
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3226
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May 11, 2024
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🇪🇺 EDQM - Certification of suitability to Monographs of the European Pharmacopoeia
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1
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553
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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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1690
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April 2, 2024
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USP-NF General Notices Revision open for Comments
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0
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1129
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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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1098
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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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582
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February 16, 2024
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New ICH Guideline Q14
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0
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481
|
February 12, 2024
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Nitrosamine requirements for probiotics
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4
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352
|
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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635
|
February 9, 2024
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Notifying FDA of a Discontinuance or Interruption in Manufacturing
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0
|
254
|
February 7, 2024
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🇪🇺 EMA/409815/2020 Rev.20
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7
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5011
|
January 31, 2024
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Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
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4
|
625
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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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1038
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January 23, 2024
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