By: Chad A. Landmon and Suzanne E. Bassett , POLSINELLI PC THIS ARTICLE PROVIDES GUIDANCE ON THE IMPACT of the U.S. Supreme Court’s recent decisions in Loper Bright 1 and Corner Post 2 on decision-making by the U.S. Food and Drug Administration (FDA). ...
By: Salvatore J. Russo , Margaret J. Davino , and Ali Brodie , Fox Rothschild, LLP This article provides an overview of significant legal issues facing healthcare organizations as a result of the coronavirus disease (COVID-19) and provides practical guidance...
By: Chad Landmon and Drew Hillier , Axinn, Veltrop & Harkrider LLP This article provides guidance on Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs). This article offers an overview of the legal and regulatory framework for EUAs, provides...
By: Scott Bass and Deeona Gaskin , Sidley Austin LLP This article addresses key topics related to the management of data by drug, biologic, and medical device companies whose products are regulated by the U.S. Food and Drug Administration (FDA). This includes...
By: Cori Annapolen Goldberg , Adam Brownrout , and Sung Park , Reed Smith LLP This article provides an overview of the federal and state agencies regulating hemp and cannabidiol (CBD) products, as well as an overview of current federal and state regulations and...
By: Matthew D. Jenkins , Hunton Andrews Kurth LLP This article provides an overview of compliance obligations and federal False Claims Act (FCA) risks to healthcare and life sciences companies arising out of three funding streams made available in response to...