FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ASSESSING THE IRRITATION AND SENSITIZATION POTENTIAL OF TRANSDERMAL AND TOPICAL DELIVERY SYSTEMS FOR ANDAS; REVISED DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Aug. 3 -- Food and Drug Administration has issued a notice called: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Aug. 3 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Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vi...