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About the Regulatory Intelligence category
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0
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264
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August 3, 2023
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🇺🇸 FDA updates 'estimated duration' dates on Recommended Interim AI limits
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1
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244
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August 3, 2026
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Nitrosamine limit in the specification based on intermediate and accelerated stability condition results
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4
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257
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April 28, 2026
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🇸🇬 Singapore formalized Nitrosamine requirements for NDA and GDA Applications
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0
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158
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April 1, 2026
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Question on established limits
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7
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371
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September 1, 2025
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🇨🇭 SwissMedic Nitrosamine impurities: Udpated requirements
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1
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544
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July 1, 2025
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FDA Requirement to inform about nitrosamine risk in ongoing/new clinical trials
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2
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341
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December 13, 2024
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Variation for new spec due to updated EMA Guideline
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7
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835
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July 16, 2024
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Regulatory Differences between EMA and FDA on Nitrosamines
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1
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521
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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
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255
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February 28, 2024
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Adoption of CPCA beyond FDA/ EMA
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9
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1068
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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
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438
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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
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383
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December 8, 2023
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