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About the Regulatory Intelligence category
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0
|
261
|
August 3, 2023
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Nitrosamine limit in the specification based on intermediate and accelerated stability condition results
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|
4
|
222
|
April 28, 2026
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🇸🇬 Singapore formalized Nitrosamine requirements for NDA and GDA Applications
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0
|
135
|
April 1, 2026
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Question on established limits
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7
|
333
|
September 1, 2025
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🇨🇭 SwissMedic Nitrosamine impurities: Udpated requirements
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1
|
502
|
July 1, 2025
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FDA Requirement to inform about nitrosamine risk in ongoing/new clinical trials
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2
|
307
|
December 13, 2024
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Variation for new spec due to updated EMA Guideline
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|
7
|
793
|
July 16, 2024
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Regulatory Differences between EMA and FDA on Nitrosamines
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|
1
|
501
|
June 25, 2024
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Entidades regulatorias y su postura en el análisis de nitrosaminas en estudios de estabilidad de preparados farmacéuticos
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0
|
255
|
February 28, 2024
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Adoption of CPCA beyond FDA/ EMA
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|
9
|
1057
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January 31, 2024
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Would we expect new regulations evolution for "PFAS" similar to what the industry had for Nitrosamines since 2018?
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1
|
431
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December 19, 2023
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Risk for dossier submission link to secondary amine present on API related impurity
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0
|
379
|
December 8, 2023
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