FDA Seeks Legislative Authority to Inspect All Facets of a Trial

A move is underfoot to grant the FDA direct legislative authority to inspect all aspects of a clinical trial. A discussion draft of the legislation, posted on the website of the House Energy and Commerce Committee, would amend the Federal Food, Drug and Cosmetic Act to allow FDA officials direct authority to inspect drugmakers, clinical sites, monitors, IRBs, or any other entity — except the subject — involved in the clinical investigation of a drug. The legislation is not expected to move forward before the legislative session ends later this year.
Clinical Trials Advisor