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Wednesday, June 22 • 9:15am - 10:15am
#310: BsUFA III and GDUFA III: Increasing FDA’s Authority to Enhance Competition

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-603-L04-P ; CME 1.00; RN 1.00

This fall, Congress will reauthorize the third iteration of the generic drug and biosimilar user fee amendments. Since the passage of the first user fee act in 1992, user fee programs have helped finance FDA’s review of human medical products. By authorizing the collection of user fees, FDA can help generate regulatory predictability and ultimately increase patient access to these critical products. Each reauthorization brings big changes and enhancements to the review program, some more nuanced than others. This session will discuss the current climate for generic and biosimilar products, the challenges companies face in bringing these products to market within the current regulatory framework, and how the new enhancements under GDUFA III and BsUFA III will increase patient access to affordable medicines.

Learning Objectives

Identify enhancements in FDA’s review of generic and biosimilar applications under GDUFA III and BsUFA III; Discuss challenges generic and biosimilar sponsors face in bringing their products to market.


Lisa Parks, RPh


Hillel P Cohen, PhD

Molly Ventrelli

Katherine Wilson, JD

avatar for Lisa Parks

Lisa Parks

Principal, Daedal Regulatory Strategies, LLC, United States
Lisa holds an R.Ph. in Pharmacy from the Massachusetts College of Pharmacy in Boston, MA. Lisa is Principal of Daedal Regulatory Strategies, LLC, a consultancy specializing in navigating complex regulatory and scientific issues involving interactions with the FDA. In her previous... Read More →
avatar for Hillel Cohen

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc., United States
Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas... Read More →

Molly Ventrelli

Senior Vice President, Regulatory Affairs, Fresenius Kabi USA, LLC , United States
Molly Ventrelli has over 30 years of experience in the generic drug industry with a primary focus in regulatory affairs. She has held various roles in Quality, Development and Pharmacovigilance as well. She is currently the Sr. VP of Regulatory Affairs for Fresenius Kabi US IV Generics... Read More →
avatar for Katherine Wilson

Katherine Wilson

Head, Regulatory Affairs Intelligence, Policy and Training, Viatris, United States
Katie Wilson is Head, Regulatory Affairs Intelligence, Policy, & Training at Viatris, a global healthcare company committed to empowering people worldwide to live healthier at every stage of life. In her current role, Katie provides regulatory support to drive global policy initiatives... Read More →

Wednesday June 22, 2022 9:15am - 10:15am CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum