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FDA Data Revamp Promises Better Enforcement, Top Official Says

Aug. 4, 2022, 11:03 PM

A data modernization plan underway at the FDA can lead to major improvements in the agency’s ability to propose new product standards and defend its actions in lawsuits, a top FDA official said Thursday.

“If we want to do enforcement and we want to take a court case, we have to have the data, we have to have the information in the briefs” to “make our case.” Janet Woodcock, the Food and Drug Administration’s principal deputy commissioner, said in a webinar with the Alliance for a Stronger FDA. “Everything we do is controversial.”

Her remarks come as the FDA seeks ...