Regulatory Intelligence
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About the Regulatory Intelligence category
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0 | 257 | August 3, 2023 |
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Question on established limits
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7 | 304 | September 1, 2025 |
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🇨🇭 SwissMedic Nitrosamine impurities: Udpated requirements
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1 | 422 | July 1, 2025 |
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FDA Requirement to inform about nitrosamine risk in ongoing/new clinical trials
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2 | 250 | December 13, 2024 |
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Variation for new spec due to updated EMA Guideline
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7 | 721 | July 16, 2024 |
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Regulatory Differences between EMA and FDA on Nitrosamines
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1 | 490 | 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 | 250 | February 28, 2024 |
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Adoption of CPCA beyond FDA/ EMA
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9 | 1031 | 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 | 425 | 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 | 368 | December 8, 2023 |