HPM Issues Detailed FDAAA Summary and Analysis

Earlier today, Hyman, Phelps & McNamara, P.C. issued its detailed summary and analysis of the recently-enacted FDA Amendments Act (“FDAAA”).  A copy of the summary and analysis is available here. 

FDAAA reauthorizes several user fee and pediatric-related laws, and includes a host of new provisions, the longest reaching of which concern drug safety.  FDAAA also creates a new Direct-To-Consumer (“DTC”) television ad user fee system.  Last week, FDA’s Division of Drug Marketing, Advertising, and Communications established a website dedicated to DTC user fee issues.  In addition, FDA issued its PDUFA IV Performance Goals.  A copy of the transmittal letter to Congress is available here, and the Performance Goals document is available here.  Information on medical device user fees is available here.  FDA’s drug and device user fee rates for Fiscal Year 2008 will be published in the Federal Register tomorrow.  Pre-publication versions of those notices are available here (drug) and here (devices).