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Safety Label Updates to Be Presented Sooner After FDA Office Change

September 8, 2016

Drug safety label information will be available closer to its approval date now that CDER’s Office of Communications is handling label changes, CDER Director Janet Woodcock said.

The Office of the Commissioner’s MedWatch Program will no longer oversee the safety label change program, which will expedite the availability of information on safety labeling changes. Woodcock notes that, under the MedWatch Program, updates were available on a monthly basis.

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