May 26, 2019iom

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Post-Approval Gap

Ex-Official: FDA Needs Resources

March 26, 2007

The rules for FDA officials are strict: Thou shalt not plead for money from Congress. But the rules don’t necessarily apply to Susan Ellenberg, now a professor at the University of Pennsylvania’s medical school. Last week, she told the DIA‘s 22nd Annual Clinical Data Management Conference that the FDA needs more resources. She should know. From 1993-2004, she was the Center for Biologics Evaluation and Research’s director of biostatistics and epidemiology. Ellenberg didn’t actually beg at all, to be sure. But she was in a position to be candid, and made it clear that inadequate resources from Congress may be one of the reasons Congress itself is frustrated with the FDA. “FDA will never beg for resources to do its job, because FDA is not allowed to beg for resources,” Ellenberg told the audience in Orlando in late March. “An agency whose mission is to promote and protect the health of…more...

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