Zdrowie i gospodarka · 27/08/2012

FDA Releases Draft Guidance for Generic Drug Facilities to Self-Identify

The Food and Drug Administration (FDA) has made available a draft guidance document for the pharmaceutical industry, outlining the requirements for generic drug facilities, sites, and organizations to self-identify and provide identification information to the FDA, in accordance with the Generic Drug User Fee Amendments of 2012 (GDUFA).