Fixing potholes with PDUFA

Rather than pave new ground, industry and FDA have agreed PDUFA VI will be more about fixing potholes that have been persistent impediments to modernizing the agency's oversight and review of drugs, and providing more resources to promote the expansion of projects started under PDUFA V.

A draft PDUFA VI goals letter, the formal document that spells out the agreement, is under review by FDA, PhRMA and BIO, and has not been publicly released. Participants in the negotiations have confidentially discussed its contents with BioCentury. ...