Hello RAPS Members,
This month’s member benefit comes to you straight out of the new 2011 RAPS Sessions Library.
As a RAPS member, you now have exclusive access to two complete sessions from the 2011 RAPS Sessions Library.
Speeding Access to Therapeutic Goods
This session will provide an overview of what’s in the regulatory toolbox to accelerate development and approval of new drugs, a case study on the New Drug Application (NDA) review and approval of JEVTANA® in just 78 days and a mother’s quest for a drug treatment for Niemann Pick Type C disease.
MDUFMA Reauthorization
The current medical device user fee program sunsets on 30 September 2012, and as a prerequisite to reauthorization, the US Food and Drug Administration (FDA) must submit a user fee package to Congress by 15 January 2012, which outlines its reauthorization requests and related performance goals. Despite numerous meetings, however, the groups have not reached a consensus on FDA’s performance goals and related user fees.
I hope you enjoy these sessions, and that if you missed 2011 RAPS this year that you will be able to join us next year in Seattle for 2012 RAPS.