|
About the Regulatory Intelligence category
|
|
0
|
261
|
August 3, 2023
|
|
Nitrosamine limit in the specification based on intermediate and accelerated stability condition results
|
|
4
|
220
|
April 28, 2026
|
|
🇸🇬 Singapore formalized Nitrosamine requirements for NDA and GDA Applications
|
|
0
|
132
|
April 1, 2026
|
|
Question on established limits
|
|
7
|
333
|
September 1, 2025
|
|
🇨🇭 SwissMedic Nitrosamine impurities: Udpated requirements
|
|
1
|
499
|
July 1, 2025
|
|
FDA Requirement to inform about nitrosamine risk in ongoing/new clinical trials
|
|
2
|
303
|
December 13, 2024
|
|
Variation for new spec due to updated EMA Guideline
|
|
7
|
787
|
July 16, 2024
|
|
Regulatory Differences between EMA and FDA on Nitrosamines
|
|
1
|
498
|
June 25, 2024
|
|
Entidades regulatorias y su postura en el análisis de nitrosaminas en estudios de estabilidad de preparados farmacéuticos
|
|
0
|
255
|
February 28, 2024
|
|
Adoption of CPCA beyond FDA/ EMA
|
|
9
|
1057
|
January 31, 2024
|
|
Would we expect new regulations evolution for "PFAS" similar to what the industry had for Nitrosamines since 2018?
|
|
1
|
431
|
December 19, 2023
|
|
Risk for dossier submission link to secondary amine present on API related impurity
|
|
0
|
378
|
December 8, 2023
|