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PDUFA and BsUFA Reauthorization Developments Webinar on Nov. 8, 2022

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FALLS CHURCH, Va. (PRWEB)

PDUFA and BsUFA Reauthorization Developments

What Regulatory, Compliance, and Quality Professionals Need to Know

Tuesday, Nov. 8, 2022, 1:30 p.m.–3:00 p.m. EST

https://wcg.swoogo.com/pdufa-and-bsufa

After challenging debates, Congress passed a bare-bones reauthorization of the prescription drug and biosimilars user fee programs.

What does this package contain? What did Congress leave out? What does the future hold for the accelerated approval and clinical trial diversity drug- and biologic-related riders? What does this mean for biosimilar interchangeability?

Jessica 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, will walk attendees through the potential fate of the remaining provisions so they will be ready when, or if, the initiatives take effect.

Ms. Greenbaum will provide:


  • 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, take their seats in January. Now is the time to prepare for the inevitable changes.

Webinar Details

PDUFA and BsUFA Reauthorization Developments

What Regulatory, Compliance and Quality Professionals Need to Know

Tuesday, Nov. 8, 2022, 1:30 p.m.–3:00 p.m. EST

https://wcg.swoogo.com/pdufa-and-bsufa

Price:

$287

Easy Ways to Order:

Online: https://wcg.swoogo.com/pdufa-and-bsufa

By phone: 888.838.5578 or 703.538.7600

About WCG FDAnews:

WCG FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on WCG FDAnews’ newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations. Learn more at fdanews.com.

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