Throwing The Postmarketing Switch: On- and Off-Schedule Commitments And Requirements
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Safety studies imposed under FDA Amendments Act authorities are a growing portion of sponsors’ post-approval study burden, while post-marketing commitments are declining, according to the latest FDA annual report on the status of post-marketing requirements and commitments.
"We're particularly concerned about the health care area right now because obviously that's driving everything now," says Tennessee AG Herbert Slatery III. He and CRN CEO Steve Mister spoke with HBW Insight about regulation of the consumer health marketplace with FDA suspending inspections of facilities operated by businesses manufacturing and marketing products subject to its oversight.