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19:36
YouTube
BBIU - BiopharmaBusinessIntelligenceUnit LLC
BBIU | CTD Module 1: Generality & The U.S. Regulatory Gateway
CTD Module 1: Generality & The U.S. Regulatory Gateway No matter how strong the clinical data in Modules 2–5 may be, a single omission in Module 1 can collapse an entire drug application. The FDA does not open the scientific dossier until the administrative, legal, and labeling requirements are validated. This means that a missing signature ...
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3 months ago
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