Notice Number: NOT-FD-14-009

Key Dates
Release Date: May 29, 2014

Issued by
U.S. Food and Drug Administration (FDA)

Purpose

The purpose of this Notice is to inform the community that PA-11-310 has been reissued as PAR-14-237. If you have successfully submitted an application prior to the termination of PA-11-310 and it has made it passed validations with no errors, you do not need to submit another application. The last due date of July 15, 2014, was transferred to the reissued FOA PAR-14-237. Please read the new FOA in its entirety.

Inquiries

Please direct all inquiries to:

Martin Bernard
Food and Drug Administration (FDA)
Email: Martin.Bernard@fda.hhs.gov