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Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products
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Amanda Jones from the Office of Generic Drugs discusses how to calculate the maximum daily dose (MDD) for oral dosage forms based on the reference listed drug labeling. Jones also discusses common assessment issues encountered when evaluating the MDD.
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone - (301) 796-6707 I (866) 405-5367
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone - (301) 796-6707 I (866) 405-5367
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