FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: SAFETY LABELING CHANGES-IMPLEMENTATION OF SECTION 505(O)(4) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Sept. 19 -- Food and Drug Administration has issued a notice called: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Sept. 19 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act." This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require applica...