The first months of 2023 have been busy for the FDA: the normalization of COVID-19, staff returning to the office, the implementation of PDUFA VII, issuance of new guidances for the drug, biologics and device industries, and so much more.
FALLS CHURCH, Va., April 18, 2023 /PRNewswire-PRWeb/ -- Commissioner Robert Califf has ended his first year as commissioner in the Biden Administration and is now navigating the agency toward his goals: reforms to the product development process, greater reliance on real-world data, more emphasis on orphan drugs and devices, new requirements for accelerated approval drugs, and increased discussion on the role of advisory committees.
The FDA is in the process of implementing new user fee programs and an enlarged budget authorization. It must also deal with a new Congress and new committee chairs in both the Democratic-controlled Senate and the Republican-controlled House.
Wayne L. Pines, president of healthcare at APCO Worldwide and former associate commissioner of the FDA, along with a panel of experts, will provide a detailed analysis of the latest actions in 2022 under Biden/Califf leadership and insight on what to anticipate in the future. They will focus on practical guidance on how pharmaceutical and medical device manufacturers can adapt to the new FDA.
This webinar will explore what's happened and what the future may hold at the FDA, including:
- The post-pandemic adoption of new administrative and personnel practices
- How the new provisions in the user fee legislation will affect daily business
- How key personnel changes in the FDA are impacting policy
- How CDER, CBER, and CDRH are rethinking the research and development process and their own review and approval standards
- What to expect in terms of emergency authorizations, accelerated approvals, breakthrough and fast-track programs, over-the-counter drug monograph reviews, adaptive trials, and drug importation initiatives
- Expanded opportunities and staff growth in cell and gene therapy products and regenerative medicine
- Regulation of AI and software, including digital therapeutics as a medical device
- Inspection policies and procedures
- Advertising and promotion policies and enforcement
Webinar Details
Califf's FDA, 2023 and Beyond
Key Developments, Insights, and Analysis
An FDAnews Webinar Special Edition
Thursday, April 27, 2023, 1:30 p.m.–4:30 p.m. EDT
https://wcg.swoogo.com/caiffs-fda-2023-and-beyond
Tuition:
$337
Easy Ways to Order:
Online: https://wcg.swoogo.com/caiffs-fda-2023-and-beyond
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, WCG FDAnews, 703.538.7665, [email protected]
SOURCE WCG FDAnews
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