Overview
FDA recently issued an array of COVID-19- related guidance documents that facilitate expanded availability of certain medical products during the current public health emergency through enforcement discretion and other temporary policies. These products include diagnostics, personal protective equipment, remote monitoring devices, ventilators, disinfectant devices, clinical electronic thermometers, and hand sanitizers. This webinar will examine the scope of these guidances, their impact on regulated companies, and how they relate to other FDA requirements, such as Emergency Use Authorizations.
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Speakers
Hannah Bornstein, Partner, Nixon Peabody LLP
Carmine Jabri , President, E.M.M.A. International Consulting Group, Inc
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Gregory H. Levine, Partner, Ropes & Gray LLP
CHAD LANDMON is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the IP and FDA Practice Groups. Over his 20+ years of experience, Chad has maintained a particular focus on FDA litigation and patent trial work, having served as a first chair trial lawyer on multiple cases and having litigated over 50 cases in numerous federal district and appellate courts in the last 10 years alone, many of which have involved products with billions of dollars in annual sales. In addition to his patent litigation practice, his FDA work involves client counseling and petitioning FDA relating to pharmaceuticals, biologics,medical devices, and regenerative medicine products. During the course of his career, Chad has worked on eight of the top ten generic drugs ranked by cost savings and nearly half of the top 100 generic drugs by sales volume. Chad’s practice also includes matters involving the intersection of the antitrust, FDA,and patent laws, such as issues arising from the settlement of patent and FDA exclusivity disputes
HANNAH R. BORNSTEIN is a partner and the deputy practice group leader of Nixon Peabody’s Government Investigations & White-Collar practice group and is also a member of the firm’s Life Sciences team.She represents individuals and multi-national companies in compliance matters, investigations and litigation. She is experienced in health care industry matters involving the False Claims Act; the Food,Drug and Cosmetic Act; and the Anti-Kickback Statute. Hannah represents life sciences companies, including pharmaceutical and medical device companies, in responding to governmental inquiries or investigations conducted by the United States Attorney’s Office and the Department of Justice, among others. She has advised companies in responding to grand jury subpoenas, HIPAA subpoenas and civil investigative demands(CIDs), as well as informal requests for information. She assists companies in conducting internal investigations into potentially problematic conduct within a company and provides pro-active compliance advice, including compliance with FDA regulations.
GREGORY H. LEVINE is chair of the FDA regulatory practice group,focuses his practice on FDA regulation of pharmaceuticals,biotechnology and medical devices, regularly representing such clients before state and federal regulators on all phases of the product lifecycle, and assisting with both internal and government compliance investigations and enforcement actions. Greg also advises manufacturers of other FDA-regulated products, including cosmetics and dietary supplements,on a broad range of issues under the Food,Drug, and Cosmetic Act and related laws. Prior to joining Ropes &Gray, Greg was a partner at an international law firm in Washington,DC. He is also a former legislative staff member in the US House of Representatives, where he worked on FDA-related legislation, policy,and appropriationsVirtual Learning FAQ
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