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Description: How does a start-up biotech company deal with FDA? Should seriously ill patients have access to unapproved drugs or biologics that might extend their lives? Why are there delays in FDA approval of some generic drugs? How does FDA go about deciding whether Americans should have access to a new drug—or not? Reviews FDA’s regulation of prescription drugs and biologics. Discusses the relevant parts of the Food Drug & Cosmetic Act and FDA’s regulations. Includes the development of drugs and biologics from preclinical studies to investigational new drug status to post-approval (‘Phase IV’) studies. Discusses generic drugs, orphan drugs, and biosimilars. Examines ‘market exclusivity.’ Explores the public debate on ‘compassionate use’ of unapproved drugs and biologics. Introduces whether FDA should continue to withhold from public disclosure clinical data submitted to support the approval of drugs and biologics.