FDA Announces the FY 2014 Reporting Period for Generics Facilities

Apr 16, 2013

FDA

On April 15, 2013, the U.S. Food and Drug Administration published a Federal Register notice announcing the fiscal year (FY) 2014 reporting period (May 1 to June 1, 2013) for self-identification of generic drug facilities, sites and organizations. Under GDUFA, human generic drug facilities, sites and organizations are required to submit, update or reconfirm their identification information annually.

This notice specifies the FY 2014 reporting period from May 1 to June 1, 2013; the second year that self-identification is required. It summarizes the requirement and refers readers to additional information on FDA’s GDUFA web page including who is required to self-identify, the type of information required, the format for submission, and the penalty for failing to comply. The notice can be found here 

Questions about GDUFA can be sent to AskGDUFA@fda.hhs.gov or (866)-405-5367.

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments