Learning Tracks

Enacted in 2012, the Generic Drug User Fee Amendments (GDUFA) enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications which ultimately help to get more generic and biosimilar medicines to patients more quickly. The law must be renewed every five years, including a negotiation between industry and the FDA and reauthorization of the law by the U.S. Congress. In this session, panelists from AAM’s membership who participated as industry negotiators will explore the changes we can anticipate during GDUFA IV (tentatively effective October 1, 2027).

Nimi Chhina, PhD, JD
Vice President, Global Regulatory Affairs Operations, Policy & Intelligence, Teva Pharmaceuticals

Aparna Dagar, PhD, RAC
Vice President Regulatory Affairs, Fresenius Kabi USA, LLC

Jessica Greenbaum, JD
Director, Regulatory Affairs Policy U.S., Sandoz Inc.

Kiran Krishnan, PhD
Senior Vice President, Global Regulatory Affairs, Apotex Corp.

Kalpana Vanam, MBA
Senior Vice President (Gx, Biosimilars and Specialty), Lupin Pharmaceuticals

Andrew Zacher, JD, MS
Senior Director, Regulatory & Public Policy, Amneal Pharmaceuticals