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FDAnews Announces: FDA Commissioner Robert Califf's Post-PDUFA, Post-COVID FDA Agenda Webinar on Sept. 15, 2022

·3 min read

Changes are coming to the FDA as Commissioner Califf launches his agenda post-PDUFA and post-COVID. Here's what to expect and how to prepare for 2023 and beyond.

FALLS CHURCH, Va., Sept. 6, 2022 /PRNewswire-PRWeb/ -- FDA Commissioner Califf's Post-PDUFA, Post-COVID FDA Agenda
Key Developments, Insights and Analysis
An FDAnews Webinar Special Extended Edition
Thursday, Sept. 15, 2022, 1:30 p.m.–4:30 p.m. EDT
https://wcg.swoogo.com/califfs-post-pdufa-post-covid-fda-agenda

With a new commissioner and his staff on board at the FDA, with PDUFA VII about to be implemented, and with a new normal developing as the pandemic wanes, there will be significant changes at the FDA.

As Dr. Robert Califf takes the FDA reins a second time, he's facing a whole new world and setting new priorities for the agency.

The presenters will provide a close analysis of 2022 under the Biden and Califf regimes, keen insight on what to anticipate in the future, and practical guidance on how to adapt to the new FDA.

Wayne L. Pines, president of healthcare at APCO Worldwide and former associate commissioner of the FDA, along with a panel of experts, will share what pharmaceutical and medical device professionals must know and do to get ahead of the changes.

They will look back at the crucial developments of 2022 and will discuss what will likely come in 2023, including how the multiple lessons of the pandemic will be applied to daily FDA activities, what enforcement will look like, likely inspection process innovations and more, such as:

  • What new provisions in the user fee legislation will affect daily business

  • The importance of the recent drug importation guidance and the impact of new guidances

  • How key personnel changes at FDA will make a impact

  • The impact of drug-related "crises" on CDER's approach to R&D and approvals

  • What to expect in terms of more use of emergency authorizations, accelerated approvals, breakthrough and fast-track programs, OTC drug monograph reviews, adaptive trials

  • Key elements of CBER's five-point plan

  • Expanded opportunities in regenerative medicine

  • Regulation of AI and software as a medical device

  • Harmonization efforts with the EU

  • Inspection policies and procedures

  • Advertising and promotion policies and enforcement

Webinar Details
FDA Commissioner Califf's Post-PDUFA, Post-COVID FDA Agenda
Key Developments, Insights and Analysis
An FDAnews Webinar Special Extended Edition
Thursday, Sept. 15, 2022, 1:30 p.m.–4:30 p.m. EDT
https://wcg.swoogo.com/califfs-post-pdufa-post-covid-fda-agenda

Price:
$337

Easy Ways to Order:
Online: https://wcg.swoogo.com/califfs-post-pdufa-post-covid-fda-agenda
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.

Media Contact

Michelle Butler, FDANews, 703-538-7665, mbutler@fdanews.com

SOURCE FDANews