Generic Drug Initiatives: FDARA, GDUFA II, and Administrative Proposals
Congress and FDA have both advanced efforts to enhance generic drug availability. Some efforts include changes to the generic drug user fee agreement (GDUFA), provisions in FDARA aimed at increasing transparency and providing assistance to certain generic drug sponsors, and new administrative proposals from FDA to accelerate the review of certain drugs. Panelists will assess these initiatives and discuss FDA’s current plan for implementation.
Jeffrey Francer, Senior Vice President & General Counsel, Association for Accessible Medicine (AAM), and Member, FDLI Board of Directors
Elizabeth Jex, Attorney Advisor, Office of Policy Planning, Federal Trade Commission
Maryll Toufanian, Acting Director, Office of Generic Drug Policy, CDER, FDA
Moderated by William B. Schultz, Partner, Zuckerman Spaeder LLP