This practice note discusses strategies for managing risks arising out of arrangements with third parties based in countries around the world for functions including distribution, sales and market acquisition, customs clearance, import/export processes, and license...
A company that receives a warning letter from the Food and Drug Administration (FDA) is on FDA's radar screen. In addition to responding appropriately to any actual or potential violations indicated in a warning letter, a company should be prepared for additional...
Obtain guidance on challenging adverse Food and Drug Administration (FDA) administrative decisions. This practice note includes strategies for obtaining a final agency decision that can be challenged in court, overcoming agency deference challenges, and selecting...
Learn about the regulatory background that set the stage for recent 340B Program developments and get guidance on how to navigate 340B regulatory inflection points and favorably position your clients for the future of the 340B Program. Read now » Related...
Understand the FDA’s final guidance addressing clinical decision support (CDS) software. Software intended for medical diagnosis or treatment has historically been considered a medical device subject to FDA regulation. Find out what makes a CDS product a...
Learn how the coronavirus (COVID-19) pandemic forced the U.S. Food and Drug Administration (FDA) to find innovative solutions to continue its manufacturing facility inspection program, including embracing new evaluation tools to assess compliance with current good...
Dive into this practice note for insightful guidance on negotiating and drafting clinical trial agreements (CTAs) on behalf of pharmaceutical companies. Pharmaceutical companies, commonly referred to as sponsors in the clinical trial context, often underestimate...
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...