FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PHYSICOCHEMICAL AND STRUCTURAL (Q3) CHARACTERIZATION OF TOPICAL DRUG PRODUCTS SUBMITTED IN ABBREVIATED NEW DRUG APPLICATIONS; GUIDANCE FOR INDUSTRY, AVAILABILITY

WASHINGTON, March 18 -- Food and Drug Administration has issued a notice called: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications; Guidance for Industry, Availability.

The notice was published in the Federal Register on March 18 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 final guidance for industry entitled "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs." This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and...