Life Sciences

Coronavirus (COVID-19) Legal Issues for Healthcare OrganizationsPosted on 06-17-2020

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 for effectively managing those issues. ... Read More

FDA Emergency Use AuthorizationsPosted on 04-09-2020

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 practical tips for obtaining an EUA... Read More

Data Integrity Risk Management for Life Sciences CompaniesPosted on 01-14-2020

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 strategies for identifying potential data... Read More