PDUFA and BsUFA Reauthorization Developments: What Regulatory, Compliance and Quality Professionals Need to Know – Webinar Recording/Transcript
When Congress finally passed legislation to reauthorize the prescription drug and biosimilars user fee programs, all of the new initiatives and programs the FDA and industry had spent two years hammering out were left by the wayside.
Accelerated approval … clinical trial diversity … biosimilar interchangeability … these are only some of the major provisions jettisoned at the last minute. Congressional leaders have pledged to revisit the abandoned issues by the end of the calendar year, but how and when will that happen?
You’ll get answers to those questions and more from former FDA official and regulatory expert Jessica Greenbaum in this timely presentation.
Ms. Greenbaum, counsel in King & Spalding’s FDA and Life Sciences practice and former regulatory counsel in the FDA’s Office of Therapeutic Biologics and Biosimilars, walks you through the potential fate of the remaining provisions so you’ll be ready when — or if — the initiatives of most importance to you finally take effect.
- An overview of the bare-bones user fee package Congress enacted on Sept. 30, 2022
- A deeper understanding of the key drug- and biologics-related riders that accompanied the original House and Senate bills, including those related to accelerated approval and diversity in clinical trials
- Insight into the potential consequences and impacts of these provisions, including how the proposal to amend the first interchangeable exclusivity provisions could facilitate competition
- A look at what the future holds, with congressional debate only deferred, not canceled
Congress has only two months to revive and resolve these issues before new legislators — with potentially different agendas — take their seats in January.
Things are bound to move quickly, so now is the time to prepare for the inevitable changes.
Meet Your Presenter
Jessica Greenbaum is a counsel in King & Spalding’s FDA and Life Sciences practice in Washington, DC. Prior to joining the firm, Ms. Greenbaum served as a regulatory counsel in the FDA’s Office of Therapeutic Biologics and Biosimilars. In that position, she developed and implemented regulatory policy related to biosimilars and other therapeutic biological products, including with respect to combination products, biosimilars labeling, reference product exclusivity, the Purple Book and the review and approval of biologics license applications.
Who Will Benefit
Decisionmakers in pharma and biotech companies, especially:
- Senior leadership
- Regulatory affairs professionals
- Legal counsel
- Research and development managers
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Nov. 8, 2022