PDUFA V Recommendations Promote Development of Innovative Therapies

The next step in the process is for the PDUFA V recommendations to be transmitted to Congress in January 2012.  It is critical for Congress to reauthorize PDUFA well in advance of PDUFA IV’s expiration in September 2012 in order to avoid a reduction in force at the FDA.  Even the threat of a downsizing at the FDA would be devastating to the Agency’s public health mission and its ability to review new drugs and biologics.