Guess What? It’s Almost Time to Self-Identify under GDUFA for FY 2015

Just when you thought you got it all done, it is time to do it all over again. FDA announced that the new self-identification for facilities named in a generic drug application will begin again soon.  The FDA announcement states:

Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, and certain sites and organizations identified in a generic drug submission to submit, update, or reconfirm identification information to the Food and Drug Administration (FDA) annually.  For fiscal year 2015 self-identification reporting period will begin on May 1, 2014, and close June 1, 2014. (21 U.S.C. § 379j–42(f)(2)(B)).

And very importantly please note the following:

Please note that registration and listing under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360) is a different process than self-identification under GDUFA. Many persons will thus be required to submit information separately to the respective systems. Each system populates its own database to meet unique requirements and deadlines. Both, however, are built on the same platform and based on the same technical standards.

So to make this perfectly clear, once is not enough.  Facility and product listing and registration need to be conducted as many facilities are non-GDUFA fee paying.  The self-identification process is used to keep track of the fee paying organizations, as well as identify facilities that may be fee exempt, but may still need to be inspected under the generic program.

Seems like duplication?  Yes, it is, but, until the FDA computer systems all speak to each other in a manner that is seamless, the industry will need to continue to populate these various databases using the existing infrastructure and software that FDA makes available.  Good luck and, don’t forget, now that April 15 has come and gone, the FDA tax man commeth.