Overview
The FDA has acknowledged that the COVID-19 epidemic could cause critical medical product disruptions and shortages, particularly with imports from China. FDA is actively working with companies to identify potential shortages and mitigate any impacts as early as possible. FDA has also recently approved several Emergency Use Authorizations (EUAs) for medical products used to diagnose or prevent transmission of COVID-19. What is FDA’s role in responding to public health emergencies such as COVID-19? What is FDA’s process for issuing drug, device, or biologics EUAs? What other tools does the agency have to decrease the impact of supply chain disruptions, product shortages, and disease outbreaks, and what are the legal limits to FDA’s authority? How does FDA work with other agencies and entities such as the Centers for Disease Control and Prevention and World Health Organization?
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Speakers
John Johnson III, Counsel, Shook, Hardy & Bacon LLP
Howard R. Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP
Moderated by Jeffrey K. Shapiro, Partner, Hyman, Phelps & McNamara, PC
HOWARD R. SKLAMBERGis a partner at Akin Gump Strauss Hauer & Feld LLP. From 2014-April 2017, Howard served as USFDA’s Deputy Commissioner for Global Regulatory Operations and Policy, where he oversaw the Office of Regulatory Affairs and the Office of International Programs. He led or co-led many quality and safety efforts (including inspection modernization and program alignment) and the negotiation and implementation of GDUFA and GDUFA II. Howard directed FDA’s multilateral initiatives and its overseas offices. Howard also served as Director of CDER’s Office of Compliance and Deputy Associate Commissioner for Regulatory Affairs.
JEFFREY SHAPIRO is a director with the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC. He specializes in medical device law, advising and representing companies before FDA for more than 20 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s and warning letters. In recent years, he has particularly focused on digital health issues. As an advisor to start-ups, mid-sized, and large medical device manufacturers, Mr. Shapiro recognizes the operational and financial considerations involved in managing compliance and creating regulatory strategies. Mr. Shapiro actively contributes to industry conversations on medical device regulations. He is a member of the Editorial Advisory Board for both MDDI and Update magazines, co-editor of two textbooks, Promotion of Biomedical Products (Food and Drug Law Institute, 2006) and Combination Products, How to Develop the Optimal Strategic Path for Approval (FDA News 2005), has contributed chapters to many textbooks, and is a frequent speaker and contributor to the firm’s FDA Law Blog, among other publications.Virtual Learning FAQ
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