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The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.
On July 25, 2017, FDA published guidance answering questions regarding the Generic Drug User Fee Amendments of 2012 (GDUFA), specifically on self-identification, drug reviews, and inspections. The agency released the guidance to “promote transparency and facilitate compliance” and assist manufacturers in meeting GDUFA requirements. It is one in a series of GDUFA communications. Previous drafts of this guidance were published in 2012 and 2013.
The guidance answers questions on who is required to self-identify, traditional definitions of manufacturers, facility fees, companies with multiple locations, packaging companies, contracting manufacturers, and more. Information addressed in the document regarding generic-drug submissions includes prior-approval supplements, drug master files, FDA’s refuse to receive policy, correctable deficiencies, and more. FDA also clarifies questions on inspections and compliance including inspection of foreign facilities. It also defines risk-adjusted parity and fatal flaw.