RGA 6660 — Therapeutic Product Development: A Regulatory Overview
3 semester hoursGraduateLecture
Examines every step of the therapeutic development and regulation process within the Center for Biologic Evaluation and Research and Center for Drug Evaluation and Research, from preclinical testing through postmarketing adverse experience reporting. Offers students an opportunity to conduct a comprehensive and up-to-date analysis of the complete U.S. pharmaceutical and biological products approval processes. Considers U.S. Food and Drug Administration standards for nonclinical testing/quality assurance issues and good laboratory practice, investigational new drug applications, and therapeutic market applications. Reviews process initiatives designed to speed therapeutic product review, as well as current good manufacturing practice regulations to assure quality of marketed products. Also discusses regulation of generics, biosimilars, and orphan drugs.