New Drug Development: A QA/Regulatory Overview
RGA6201 / 4 q.h.
Formerly RA 3201.
Examines every step of the drug development and regulation process, from preclinical testing through postmarketing adverse experience reporting. Considers FDA standards for nonclinical testing-quality assurance issues and good laboratory practice, investigational new drug application (NDA) and review process initiatives designed to speed drug review, and the Prescription Drug User Fee Act (PDUFA).
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