www.fdanews.com/articles/149881-fda-sets-dec-1-gdufa-self-identification-deadline
FDA Sets Dec. 1 GDUFA Self-Identification Deadline
October 2, 2012
Generic-drug makers must submit self-identification information to the FDA by Dec. 3 to comply with the recently passed Generic Drug User Fee Amendments of 2012. Facilities that fail to self-identify will have their products labeled as misbranded, according to a Federal Register notice scheduled to publish Oct. 2.
Drug Industry Daily
Drug Industry Daily