New York/New Jersey Chapter: Update on GDUFA II

When:  Apr 19, 2018 from 5:30 PM to 8:30 PM

Thursday, 19 April 2018
5:30-8:30 pm EST
Hyatt House Branchburg
3141 Route 22 East
Branchburg, NJ 08876
+1 908 704 2191

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe and high quality generic drugs and products. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry.

Topics to be covered will include:

  • What’s new with GDUFA II
    • Pre-ANDA program
    • Expeditated/priority review
    • Review program enhancement
    • Review status update
    • POST CRL meetings
    • Requests for reconsideration
  • Implementation of GDUFA II
    • Implementation meetings with FDA
    • Year-to-date metrics and results
  • Recommendations for success
    • What to do when not receiving expected feedback

The RAPS New York/New Jersey chapter invites you to join others from the local regulatory community to explore this important topic with your colleagues. Light refreshments will be available to all attendees. RAC holders may claim two RAC recertification credits.

Featured speaker:
Scott Tomsky, MS, vice president, generics regulatory affairs, North America, Teva Pharmaceuticals

Registration Information:
RAPS Member: $35
List: $50


3141 US Highway 22
Branchburg, NJ 08876-3528