New FDA Rule Broadens Scope Of Clinical Investigator Bans

Law360, New York (April 27, 2012, 3:57 PM EDT) -- A U.S. Food and Drug Administration rule released Friday would disqualify clinical investigators who are ineligible to conduct preapproval studies of one type of FDA-regulated product — like drugs or medical devices — from conducting studies for other types, too.

The FDA said the rule comes in response to a September 2009 report from the Government Accountability Office, which pointed out that an investigator who is disqualified from conducting clinical studies in support of FDA approval for one category of products, like drugs, would still be...
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