Operators of generic drug facilities and certain sites and organizations that are identified in the generic drug submission must submit "Self-Identification" information to FDA.
(PRWEB) October 15, 2012
Under the Generic Drug User Fee Amendments (GDUFA) of 2012, FDA is authorized to collect application fees for 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. GDUFA is a part of the FDA Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012.
As of October 2, FDA has instituted the “Self-Identification” requirement. Operators of generic drug facilities and certain sites and organizations that are identified in the generic drug submission must submit “Self-Identification” information to FDA. FDA will use this information to determine which firms must pay the new Generic Drug Facility fee and in what amount. There is no fee to submit “Self-Identification” information. Establishments that are required to submit the “Self-Identification” information to FDA must do so by December 3, 2012. Under GDUFA, if a facility fails to “Self-Identify,” FDA will deem all Final Dosage Form (FDF) or Active Pharmaceutical Ingredient (API) products manufactured at the facility and all FDFs containing APIs manufactured at the facility as misbranded. These products may be denied entry into the United States.
To find out if your establishment must “Self-Identify,” please visit http://www.registrarcorp.com/fda-drugs/self-identification.
If you have questions about the new “Self-Identification” requirement, GDUFA, FDASIA, or any other FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call Registrar Corp at +1-757-224-0177.