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The New Intensified Scrutiny and Enforcement of FDA-Regulated Clinical Trials


Pharmaceutical and medical device companies should be aware that the U.S. Department of Justice (“DOJ”) has intensified its enforcement activities related to FDA-regulated clinical trials. The Consumer Protection Branch, which is the principal DOJ component charged with enforcing the Federal Food, Drug, and Cosmetic Act (“FDCA”), has recently announced its intent to aggressively identify and prosecute clinical trial fraud in pharmaceutical and medical device research. These developments are occurring in the context of the long-standing focus of FDA’s Bioresearch Monitoring Program (“BIMO”) on ensuring the integrity of clinical trial data and human subject protection, and the agency’s new concerns about data integrity during COVID-19 disruption of clinical trial conduct. This webinar will discuss and focus on:

  • DOJ enforcement priorities with respect to clinical trial misconduct and fraud;
  • The implications of recent DOJ enforcement actions regarding clinical trials, including United States v. Raventos et al., United States v. Demming et al. and United States v. Bencosme;
  • Administrative and enforcement actions that FDA may independently take without DOJ involvement following “routine” as well as “for cause” inspections;   
  • Recent FDA clinical trial enforcement trends and high risk issues;
  • Compliance programs and specific preventive and corrective measures that companies should take regarding both clinical investigators and contract research organizations (“CROs”) prior to initiation of a clinical trial, during its conduct and if misconduct is identified.

If you have questions concerning this roundtable webinar, email Chayako Williams at cbwilliams@kslaw.com.

CLE

King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida, and New Jersey. We will apply for credit in Colorado, North Carolina and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly-admitted and experienced attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias, garias@kslaw.com. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.

Event Details

Date: March 16, 2021

Time: 1:00 pm (ET)

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