The Biden FDA’s numerous first-year changes — and the resulting impact on your drugs/biologics and devices — are far from over. To minimize negative effects on your products and your business, you’ll need to take steps now to prepare. This special expanded-edition webinar will provide all the intel you need.
You’ll gain insights into key FDA developments from 2021, understand what to expect in 2022 and find clarity on the policies and programs you’ll need to implement.
This webinar will help answer your biggest questions about new and forthcoming changes to FDA policies and personnel, including: What will the FDA do about the enormous backlog of inspections? What will be its role be in drug pricing? Will the agency change the advertising and promotion rules for prescription drugs/biologics and devices? What can it do about escalating supply chain challenges?
Wayne L. Pines, president of healthcare at APCO Worldwide and former associate commissioner of the FDA, will illuminate all of this and more. Along with a panel of experts, he will share what you must know and do to comply with the current — and coming — changes so you can avoid missteps:
- The major FDA issues, challenges and accomplishments of 2021
- The priorities for the new FDA commissioner in 2022
- The priorities for the FDA medical centers in 2022 as they transition to a new normal
- Provisions to be included in user fee legislation and how they will affect daily business
- How companies can best adapt to the Biden administration’s post-COVID FDA
- What new guidance is likely to be issued in 2022
- Key personnel changes under Biden’s FDA
- CBER’s five-year plan: the key elements you must know about
- Will there be expedited drug approval as a result of the positive aspects of vaccine development?
- Will there be expanded opportunities in regenerative medicine?
- The current status of software as medical devices
- The status of harmonization efforts with the EU
- And much more!
Forewarned is forearmed: prepare for what is coming from the FDA with this special expanded-edition webinar.
Who Will Benefit:
- Quality Professionals
- Regulatory Professionals
- Legal Professionals
- Compliance Professionals
- PR/Advertising Personnel