FDA regulation on Overage of drug product [Regulatives / Guidelines]

posted by jag009  – NJ, 2012-05-18 23:05 (5155 d 22:26 ago) – Posting: # 8586
Views: 4,566

Hi everyone,

Does anyone know if FDA has a guidance on overage of a drug product? Example, OROS drug products have overage. Is there a limit as to how much overage is allowed?


Thanks

John

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