Tearing Down Silos at CDER

FDA's memorandum of agreement between drug safety and drug review officials clarifies the processes by which decisions are made on significant safety issues. But one former FDAer thinks that reorganizing the center for drugs is still necessary to ensure a productive approval process.

When it comes to addressing internal strife at FDA’s Center for Drug Evaluation & Research, one former agency official wants to tear the walls down.

Scott Gottlieb, a resident fellow at the American Enterprise Institute and a former deputy commissioner at FDA, thinks the agency...

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