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DRUG DISCOVERY DEVELOPMENT (DDD)
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Question:
If NDA is accepted - __
Author: LEIGHTON DWIGHT OBILLOSAnswer:
1 detailed evaluation, 180 DAYS from submission for FDA to complete the review Comments and recommendations are made Approve the product to be marketed, approve with specific conditions (Conditional Approval), disapprove the products
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LEIGHTON DWIGHT OBILLOS