More Generic Facilities Registered During FDA Grace Period

January 4, 2013
About 350 additional generic facilities registered with the FDA during the two-week deadline extension to comply with new self-identification requirements. The Generic Drug User Fee Amendments of 2012 (GDUFA) requires generics manufacturers to self-identify to the agency. The FDA extended the initial deadline from Dec. 3 to Dec. 18. There are currently about 2,050 facilities in compliance; up about 15 percent from the approximately 1,700 identified at the initial deadline, the agency said.
Drug Industry Daily