FDA Releases Draft Agreement on PDUFA V

The U.S. Food & Drug Administration (FDA) has released a draft of performance goals and procedures agreed between industry and the agency that would underpin the Prescription Drug User Fee Act (PDUFA) V. The Biotechnology Industry Organization (BIO) has already made it clear that it is supportive of this draft set of recommendations.

• "PDUFA reauthorization performance goals and procedures fiscal years 2013 through 2017" is the draft document issued by the FDA.

• "BIO supports timely reauthorization of PDUFA to promote the development of innovative therapies and speed new medicines to patients" is a media release issued by BIO on September 1.