Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based hand sanitizers. Recognizing the significant supply disruptions for hand sanitizers, and that compounders and manufacturers are better equipped than ordinary consumers to formulate safe and effective hand sanitizer products, FDA is providing flexibility in manufacturing such products during the COVID-19 public health emergency.
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Bethany J. Hills
Bethany advises her life sciences business clients on both pre- and post-market issues, including everything from FDA submissions and communications strategies to post-approval compliance and reimbursement issues. Her clients include medical device, drug, combination product, diagnostic, biologic, and regenerative medicine, cosmetic, dietary supplement, and food industry companies, and the investor groups focusing on these industries.
Bethany leverages her deep FDA regulatory experience and exceptional knowledge More ›
Erin M. Bosman
Erin Bosman co-chairs MoFo’s Class Actions and Mass Torts Practice Group. Clients value her business strategy, seeking her comprehensive counsel throughout the product life cycle, especially in high-stakes litigation and product recalls.
Erin’s clients value her litigation acumen, retaining her as national coordinating and trial counsel in class action cases and multijurisdictional and multidistrict proceedings. A skilled negotiator, Erin has a long track record of More ›
Julie Y. Park
Julie protects her clients’ products throughout the product life cycle. Drawing on her deep technical and legal experience, she counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption. She manages complex and multijurisdictional litigation both in state and federal court and also guides clients through product recalls.
Clients appreciate Julie’s ability to assess both the practical business implications and legal impact More ›
Hilary R. Hoffman
Hilary Hoffman is an associate in the FDA Regulatory and Life Sciences Compliance group. She represents life sciences companies in connection with government enforcement actions, regulatory compliance, and internal investigations.
Hilary works with clients in a variety of life sciences industries, including pharmaceuticals, biologics, dietary supplements, and medical devices. She regularly counsels clients on issues such as good manufacturing practices, data integrity, and regulatory filings, More ›
Alexander A. Najarian
Alexander graduated from the University of California, Los Angeles, School of Law, where he was a writing advisor for the Lawyering Skills Program. While in pursuit of his J.D., he served as editor-in-chief of the Pacific Basin Law Journal.
Prior to joining the firm, Alexander gained litigation experience working as a law clerk on issues ranging from small personal injury cases to large-scale insurance defense More ›