GMP: FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics

The GDUFA (Generic Drug User Fee Act), the new act on fees due for the processing of marketing authorisation applications and the inspection of production sites came into force on 9 July 2012. This serves the accelerated processing of marketing authorisation applications for generic products and the reduction of application delays, both due to the growing torrent of applications and the lack of personnel in the review departments of the FDA.