NEW DRUG APPLICATION:
The NDA contains all of the information and data that the FDA requires for market approval of a drug.
A new drug application (NDA) includes enough information for the FDA to determine whether the new drug is safe and effective; whether the drug’s benefits outweigh its risks; whether the proposed drug label (package insert) is appropriate; and whether the drug manufacturing standards are adequate.
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0:00 Introduction
0:12 The Drug Development Process
2:09 New Drug Application (NDA)
3:59 NDA Classification
6:15 As outlined in Form FDA
7:23 NDA REVIEW PROCESS