|Event Name||CBI’s 2013 4th Annual Effective Preparation for FDA Advisory Committee Meetings
Tuesday, February 05, 2013
Wednesday, February 06, 2013
|Description||The Food and Drug Administration Amendments Act (FDAAA) of 2007, created by PDUFA-IV, required the FDA to initiate independent reviews of most new products. Since then, Advisory Committees have broadened to cover post-marketing products, individual compounds and more. With PDUFA-V pending, it is uncertain what impact the reauthorization will have on the regulatory approval and Advisory Committee process, but it will be imperative to the success of new products to be ahead of the change. This event puts you ahead of the curve.