Drug Regulation Reform Act of 1978

Abstract

Provisions of the Drug Regulation Reform Act of 1978 are discussed. Included in the discussion are drug monographs and product licenses, investigations and approvals of drugs, drug information, labeling, promotion and education, penalties, and the National Center for Clinical Pharmacology. The Act eliminates the individual NDA approach to regulation and replaces it with a system of monographs on "drug entities" and "drug product" licenses. It amplifies and redefines the investigational process to facilitate and promote research while protecting patients' rights. It also divides the commercial investigation process into two phases: drug innovation investigations and drug development investigations.