The U.S. Food and Drug Administration (FDA) will give all drug facilities required to self-identify under the Generic Drug User Fee Amendment (GDUFA) an extra two weeks to do so.
On July 9, 2012, the Generic Drug User Fee Amendment (GDUFA) became law as part of the FDA Safety and Innovation Act (FDASIA). Legislators intended for GDUFA to speed access to safe and effective generic drugs to the public and reduce costs to industry. Under GDUFA, the FDA has the authority to collect user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. GDUFA requires certain companies identified in generic drug submissions, including Abbreviated New Drug Applications (ANDA) and Prior Approval Supplements (PAS), and from holders of type II DMFs to pay user fees.
Furthermore, GDUFA also initiated a “self-identification” requirement. Now, human generic drug facilities, and certain sites and organizations identified in generic drug submissions, must provide self-identification information annually to FDA. FDA plans to use this information to determine which firms must pay the new, annual Generic Drug Facility fee and in what amount. There is no user fee related to submitting “Self-Identification” information to FDA.
The original deadline for submitting Self Identification Information was on December 3, 2012. GDUFA states that if a facility fails to “Self-Identify,” FDA will deem all drug products and Active Pharmaceutical Ingredients (APIs) manufactured in that facility as misbranded. These products may be denied entry into the United States.
On December 4, 2012, FDA announced a two-week grace period for generic drug facility self-identification. Facilities now have until December 18, 2012 to complete the self-identification process, without penalty.
If you have questions about the new “Self-Identification” requirement, GDUFA, FDASIA, or any other FDA regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call Registrar Corp at +1-757-224-0177.