November 2021: FDA looks on while major U.S. institution violate medical research rules

An article, FDA looks on while major U.S. institutions violate medical research rules, was published on TranspariMed on November 21, 2021

This article provides a comprehensive overview of FDA’s action on the Institutions violating key clinical trial disclosure law. Out of 51 large US-based companies and institutions that have failed to make five or more clinical trial results public, only three have been contacted by the U.S. drug regulator, and only one has received a final warning, FDA enforcement data show.

Between July 2020 and the end of April 2021, the FDA sent out only 54 “Pre-Notices of Noncompliance” that flagged missing trial results and instructed sponsors to make them public as required by law. When the FDA did send letters, it triggered compliance in over 90% of cases.

The article also lists all the major US-based clinical trial sponsors that have failed to make five or more clinical trial results public as required by law, and the corresponding FDA warning letters.

More information can be found here