FDA Publishes Submission Dates, Reconsideration Process for ANDA Supplements

The FDA is clearing up confusion on prior approval supplements for ANDAs, providing clarifications on reconsiderations and submissions in a final guidance document.

In a final guidance document, the FDA is making two major changes from the 2014 draft version. First, it lays out the process for asking the agency to reconsider its decision on PASs. Generics makers have 10 days after receiving notice from the FDA to request reconsideration, the FDA says.

If applicants disagree with the outcome of a reconsideration, they can initiate a formal appeal, the FDA says.