FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINING WHETHER TO SUBMIT AN ANDA OR A 505(B)(2) APPLICATION; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Aug. 18 -- Food and Drug Administration has issued a notice called: Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Aug. 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Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) i...