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EDUCATIONAL PURPOSE:
This seminar provides viewers
with an overview of the Food and Drug Administration's
role in the drug development and review process.
This seminar examines various aspects of the
Investigational and New Drug Application (IND/NDA)
processes, including clinical drug testing in
patients, the importance of the Prescription
Drug User Fee Act (PDUFA), FDA Modernization
Act (FDAMA), generic drugs and post-marketing
surveillance.
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