Notifying FDA of a Discontinuance or Interruption in Manufacturing
|
|
0
|
259
|
February 7, 2024
|
πͺπΊ EMA/409815/2020 Rev.20
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|
7
|
5136
|
January 31, 2024
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Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
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4
|
634
|
January 30, 2024
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π¬π§ Medicines: MAH' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
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2
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1041
|
January 23, 2024
|
European Pharmacopeia - Open for comments 'N-Nitrosamines in active substance and medicinal products'
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0
|
696
|
December 19, 2023
|
Health Canada updates guidance(incorrect post)
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|
2
|
503
|
January 14, 2024
|
EDQM - European Pharmacopeia - Feedback Nitrosamines
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|
3
|
1064
|
January 12, 2024
|
N Nitroso Vildagliptin amide
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|
4
|
1344
|
December 18, 2023
|
π°π· Korea Drug Review Briefing session on Nitrosamines
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|
0
|
458
|
December 12, 2023
|
NDSRI/ Guidance
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2
|
480
|
December 12, 2023
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Deadline for reporting changes
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2
|
486
|
December 5, 2023
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EMA Q&A Appendix 1 update posted Sept 28,2023
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13
|
1789
|
November 22, 2023
|
π¨π Swiss Medic Guidelines
|
|
7
|
1683
|
November 20, 2023
|
πͺπΊ EMA - Enhanced AMES test conditions
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0
|
773
|
November 15, 2023
|
EMA Q&A Rev. 19 (EMA/409815/2020 Rev.19)
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0
|
1724
|
November 13, 2023
|
Revised guidance for J-CTN
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3
|
396
|
November 9, 2023
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Nitrosamine Guidance for Cream and Ophthalmic Solutions
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4
|
734
|
November 3, 2023
|
π¦πΊ Australia / Nitrosamine impurities in medicines updates
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|
0
|
725
|
November 2, 2023
|
Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs
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|
1
|
742
|
October 31, 2023
|
π¨π¦ Health Canada Nitrosamine Guide update
|
|
5
|
2138
|
October 27, 2023
|
Investigation of experiences in handling N-nitrosamine impurities among ZaZiBoNa participating countries -Pub
|
|
0
|
522
|
October 16, 2023
|
π¨π¦ Health Canada extended deadline?
|
|
4
|
720
|
October 23, 2023
|
Reflections on the Impact of Nitrosamine Drug Substance Related Impurities
|
|
0
|
496
|
October 20, 2023
|
CPCA is now included in the updated version of Health Canadaβs Guidance on nitrosamine impurities
|
|
15
|
2531
|
October 13, 2023
|
πͺπΊ EMA Q&A Rev. 18 EMA/409815/2020 - Deadlines
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|
2
|
1317
|
October 3, 2023
|
πΊπΈ FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
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|
47
|
7122
|
September 20, 2023
|
WHO on Nitrosamines, Rifampicin, Rifapentine and NDSRIS
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|
3
|
1217
|
September 20, 2023
|
πͺπΊ EMA Q&A Rev. 16 EMA/409815/2020 - MAJOR UPDATE
|
|
108
|
24247
|
September 12, 2023
|
Fifth Nitrosamine Implementation Oversight Group (NIOG) β meeting with pharmaceutical industry
|
|
1
|
668
|
September 6, 2023
|
π¬π§ MHRA publishes guidelines for Nitrosamine Impurities
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|
4
|
1422
|
August 28, 2023
|