Cathy Burgess will speak at this webinar hosted by FDANews.
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 guidance for the drug, and biologics and device industries. Commissioner Robert Califf has ended his first year as commissioner in the Biden Administration and is now navigating the agency toward his goals.
Speakers 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, and 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
For more information, click here.