FDA Slacking On Post-Approval Follow-Up: Report

Law360, New York (July 11, 2006, 12:00 AM EDT) -- As concern over drug safety regulation and procedures continues to mount, a newly-released report by the inspector general of the U.S. Health and Human Services Department points the finger of blame at the U.S. Food and Drug Administration.

The report accuses the agency of failing to track the status of many post-approval safety studies.

All new drugs are required by the FDA to undergo clinical testing to demonstrate their safety prior to approval for sale in the U.S., but these mandatory pre-market trials involve relatively small...
To view the full article, register now.