FDA Oversight of Postmarketing Studies Slammed
30 oktober 2009
The FDA has allowed drug manufacturers to wriggle out of postmarketing study commitments for drugs approved with surrogate endpoints, the Government Accountability Office charged. In a report released Monday, the GAO accused the drug regulator of failing to routinely review manufacturers' annual submissions or otherwise supervise their postmarketing research.
Bron: medpagetoday, zie ook het volledige rapport onder Publicaties
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