GAO: FDA is lax in enforcing Phase IV studies for surrogate endpoint drugs
28 October 2009
Nancy Faigen
The
US FDA needs to enhance its oversight of accelerated drug approvals based on surrogate endpoints, the
Government Accountability Office (GAO) has said in a new report.
Congress's investigative arm found flaws in the agency's record for ensuring that the necessary post-approval outcomes studies...
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28 October 2009
Nancy Faigen
Congress's investigative arm found flaws in the agency's record for ensuring that the necessary post-approval outcomes studies...
Please Login to read the full article.
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