Public feedback to FDA on regulatory considerations for AI in drug manufacturing

Public feedback to FDA on regulatory considerations for AI in drug manufacturing

Abstract FDA’s Center for Drug Evaluation and Research (CDER) established the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to establish a regulatory framework to support the adoption of advanced manufacturing technologies that could benefit patients. FRAME prioritize...

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Bibliographic Details
Main Authors: Jayanti Das, Thomas F. O’Connor, Adam C. Fisher, Manuel Osorio, Johnny Lam, Riley C. Myers
Format: Article
Language:English
Published: SpringerOpen 2025-05-01
Series:AAPS Open
Subjects:
Pharmaceuticals
Manufacturing
Artificial intelligence
Data governance
Machine learning
Online Access:https://doi.org/10.1186/s41120-025-00110-w
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https://doi.org/10.1186/s41120-025-00110-w

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