Food, Drug, and Cosmetic Act Amendments

[AI summary unavailable — showing source text] Food, Drug, and Cosmetic Act Amendments - Amends the Food, Drug, and Cosmetic Act to authorize the Secretary of Health, Education, and Welfare to enter into a non-renewable three year preapproval marketing agreement allowing for the widespread distribution of a new drug prior to approval of its application if: (1) it has received a research exemption or an investigational new drug protocol; and (2) data derived from preclinical studies and at least one well-documented controlled clinical trial indicate safety and effectiveness, and a significant advancement in the treatment of disease. Specifies contents of an application for such an agreement. Shortens from 180 to 120 days the time within which the Secretary must dispose of an application for an investigational new drug protocol. Directs the National Academy of Sciences to establish a Select Committee which, upon request, shall review any adverse decision by the Secretary regarding an application under this Act. Limits such review to the scientific basis of the Secretary's decision. Requires inclusion of the established name of an exempted prescription drug on its label. Establishes a National Patient Information Leaflet Advisory …