Two-Week Grace Period for GDUFA Facility ID

The FDA is giving generic manufacturers until Dec. 18 to complete the self-identification process without penalty — a two week extension of the original Dec. 3 deadline, CDER said. As of the Dec. 3 deadline, more than 1,700 facilities have self-identified for fiscal 2013, the FDA said. This figure is below estimates of the number of generic drug facilities.
Generic Line