The first months of 2023 have been dramatic ones for the FDA: the normalization of COVID-19, staff return to the office, the beginning of implementation of PDUFA VII, the issuance of new guidances for the drug, biologics and device industries, and so much more.
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.
How have these initiatives changed your business? More importantly, what new initiatives are on the horizon and how can you influence them?
This special extended webinar does a deep dive into what’s happened and what the future may hold at the FDA.
The FDA is in the process of implementing new user fee programs and an enlarged budget authorization. It must deal with a new Congress and with new committee chairs in both the Democratic-controlled Senate and the Republican-controlled House.
Your presenters will provide a detailed analysis of the latest actions in 2022 under Biden/Califf leadership and keen insight on what to anticipate in the future. They will focus especially on practical guidance on how you can 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 you must know and do to get ahead of the changes.
Among the many topics they will cover:
- Adoption of new administrative and personnel practices post-pandemic
- How the new provisions in the user fee legislation will affect your daily business
- How key personnel changes in the FDA are impacting policy
- How CDER, CBER and CDRH are rethinking the R&D process and their own review and approval standards
- What to expect in terms of emergency authorizations, accelerated approvals, breakthrough and fast-track programs, OTC drug monograph reviews, adaptive trials, drug importation initiatives
- Expanded opportunities 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
- And much more!
Want to ready yourself for what the FDA has in store for the rest 2023? This special extended webinar is how to do it.
Who Will Benefit:
- Quality professionals
- Regulatory professionals
- Legal professionals
- Compliance professionals
- PR/advertising personnel