601:540. DRUG AND DEVICE LAW (2)
Examines the law and procedures for obtaining FDA approval for new drugs and devices. Focus is on the U.S. statutes and regulations, but the interplay and effects of foreign laws and regulatory processes are discussed and contrasted. The applicable federal laws, regulations and FDA policies and procedures are explored in depth. Ethical issues surrounding the drug and device approval process is also discussed. The role of the Institutional Review Board which reviews all protocols and consents for research involving human subjects is also considered.