GAO Report on Drug Safety/Foreign Drug Inspections

On October 22, 2008, the Government Accountability Office (GAO) issued a report entitled "Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program." Among other things, the GAO found that: FDA databases contain inaccurate information on foreign establishments subject to inspection; FDA inspects relatively few foreign establishments each year to assess the manufacturing of drugs currently marketed in the United States; and FDA’s identification of serious deficiencies has led foreign establishments to take corrective actions, but inspections to determine continued compliance are not always timely. The GAO recommends that FDA improve the data that it uses to manage its foreign inspection program, conduct more inspections of foreign establishments, and ensure more timely inspection of foreign establishments where FDA has identified serious deficiencies. HHS agreed that FDA should conduct more foreign inspections, and discussed other FDA oversight initiatives, such as database improvements.

Trackbacks (1) Links to blogs that reference this article Trackback URL
http://www.lifescienceslegalupdate.com/admin/trackback/92760
TortsProf Blog - October 24, 2008 7:18 AM
On this day in history, the George Washington Bridge in New York City was dedicated, and the forty-hour work week went into effect in the United States. No historical torts news, so on to recent events: Reform, Legislation, Policy Science
Comments (0) Read through and enter the discussion with the form at the end
Post A Comment / Question Use this form to add a comment to this entry.







Remember personal info?