Zdrowie i gospodarka · 23/09/2016

FDA Releases Guidance for Generic Drug Facilities to Comply with Self-Identification Requirement

The Food and Drug Administration (FDA) has made available a guidance document to help generic drug manufacturers comply with the self-identification requirement of the Generic Drug User Fee Amendments of 2012 (GDUFA), which was signed into law on July 9, 2012, and aims to speed the delivery of safe and effective generic drugs to the public while reducing industry costs.