Blog Posts

FDA Releases Draft Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application

12/04/2017

This article provides a summary of the draft guidance[1] released by the FDA to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug and Cosmetic Act (FD&C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 The draft guidance was released on October 13, 2017, for which comments are due by December 12, 2017.

Read the full blog post.