Blog Post

Dec 4, 2017

FDA Releases Draft Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

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This article provides a summary of the draft guidance[1] released by the FDA to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to the FDA. The draft guidance was released on October 13, 2017, for which comments are due by December 12, 2017.

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