The Biden Administration’s FDA: A Remarkable 2021, What to Expect in 2022 – Webinar Recording/Transcript
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 presentation 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 presentation 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 presentation.
Meet Your Presenters
Wayne L. Pines is a member of APCO Worldwide’s International Advisory Council and president of healthcare at APCO Worldwide. He has served as a trusted advisor to FDA leadership for several decades. He provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges. He served for 10 years in senior positions at the FDA including as chief media spokesman and associate commissioner for public affairs. He has authored or edited a dozen books about the FDA and was a co-founder and long-term president of the Alliance for a Stronger FDA.
Nancy Bradish Myers, JD, president of Catalyst Healthcare Consulting, Inc., is a Washington-based attorney with deep expertise in healthcare law and regulation, policy development and government relations. She has been closely involved in cutting edge drug, biotechnology and medtech regulatory issues from a range of vantage points over the past two decades. Ms. Myers advises clients from the Board room, to executive leadership teams, to Regulatory Affairs groups on regulatory and health policy matters, ranging from crisis management to long-term strategy development.
Jeffrey N. Gibbs is a director at Hyman, Phelps & McNamara in 1990. Mr. Gibbs was previously an Associate General Counsel for Enforcement at FDA, Over the course of his career, he has developed an extensive knowledge of FDA law, including regulatory strategy, product approvals, advertising and promotion, appeals, citizen petitions, and enforcement actions.
David M. Fox is a partner at Hogan Lovells. Mr. Fox is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances. He advises management teams, from start-ups to the largest global pharmaceutical and biotechnology companies, on matters before the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA). As a former senior lawyer for FDA and throughout his career in private practice, he has been deeply immersed in the regulatory side of the Hatch-Waxman Act.
Kevin M. Madagan, partner at Reed Smith is a healthcare and FDA regulatory attorney. He advises primarily about healthcare and FDA issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), combination products, and dietary supplements. Mr. Madagan’s clients span the healthcare spectrum and include suppliers, manufacturers; repackagers; wholesale and private label distributors (PLD); clinical laboratories, third-party logistics providers (3PLs); carriers; pharmacies (503A, 503B, nuclear and radiopharmacy operations); and healthcare providers. He also routinely advises strategic owners, private equity funds, underwriters and other public and privately-held businesses seeking particular FDA and healthcare support in connection with healthcare financing and securities transactions, and domestic and international mergers and acquisitions.
Who Will Benefit
- Quality Professionals
- Regulatory Professionals
- Legal Professionals
- Compliance Professionals
- PR/Advertising Personnel
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Jan. 20, 2022