This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period ends on December 19, 2014. If you would like assistance submitting a comment, please contact any of the attorneys listed in this advisory.

This public docket follows up on the Office of Generic Drug's public hearing held on September 17, 2014. Opening this docket is a step in implementing the Generic Drug User Fee Amendments of 2012 (GDUFA), specifically the FDA's commitments to: (1) expedite review of potential first-to-file ANDAs; (2) try to act within 30 months of submission to avoid forfeiture of 180-day exclusivity for failure to timely obtain tentative approval; and (3) expedite review of "first generic" ANDAs for which there are no blocking patents or exclusivities.