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DRUG DISCOVERY DEVELOPMENT (DDD)
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Question:
Information required in NDA
Author: LEIGHTON DWIGHT OBILLOSAnswer:
1 SAFETY and EFFICACY of the drug treatment 2 COMPONENTS of drug products 3 DESCRIPTION OF METHODS AND CONTROLS used in the manufacturing the AI, drug delivery system and packaging 4 Proposed LABELING SCD P
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LEIGHTON DWIGHT OBILLOS