With a new commissioner and his staff on board at the FDA, with PDUFA VII about to be implemented, with a new normal developing as the pandemic wanes, there will be significant changes at the FDA that will affect every stakeholder. What can you expect and how will it affect you and your business? This special extended webinar does a deep dive into what the future may hold.
As Robert Califf takes the FDA reins a second time, he’s facing a whole new world and setting new priorities for the agency. Newly reauthorized user fee programs, a new and enlarged budget authorization, a new Congress and possible new leadership anticipated for 2023 — not to mention the challenges of transitioning out of a pandemic — Califf has all of this in front of him, and you need to know what is likely to happen.
Your 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 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.
They will look back at the crucial developments of 2022 and look to 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 much more, such as:
- What new provisions in the user fee legislation will affect your daily business
- Importance of the recent drug importation guidance and the impact of new guidances
- How key personnel changes in the FDA will impact you
- 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
- And much more!
Want to ready yourself for what the FDA has in store into 2023? This special extended webinar is how to do it.
Who Will Benefit:
- Quality professionals
- Regulatory professionals
- Legal professionals
- Compliance professionals
- PR/advertising personnel