FDA Given New Authority to Oversee Clinical Trials Data Reporting

Raps.org: September 25, 2012

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg is receiving some new authority by way of the Department of Health and Human Services (DHHS), both agencies said in a Federal Register statement.

Under section 801 of the Public Health Service Act (PHSA)as amended by the FDA Amendments Act of 2007, DHHS is directed to establish a clinical trial registry data bank, which now exists as www.ClinicalTrials.gov run by the National Institutes of Health (NIH)’s National Library of Medicine (NLM). The website serves as a unified hub for the oversight of clinical trials, and includes information regarding the sites where a trial is conducted, the general design of a study and information about its sponsor.

Though much of the registry deals with industry-run trials in support of a drug, device or biologic regulatory submission to FDA, DHHS has until now maintained general ownership of the registry and website, including responsibility for making sure all required data is submitted on time. Read more