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BioWorld - Monday, April 13, 2026
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Home » Drug companies, US FDA burying the lede on accelerated approval
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Drug companies, US FDA burying the lede on accelerated approval

March 23, 2022
By Mari Serebrov
As congressional scrutiny of the U.S. FDA’s accelerated approval path continues, the agency is focusing research efforts into appropriate disclosure on direct-to-consumer websites about a drug’s accelerated approval and the status of confirmatory trials. Previous research by the FDA’s Office of Prescription Drug Promotion (OPDP) found that 27% of DTC websites providing information about a drug with accelerated approval don’t disclose that the products are on the market through accelerated approval.
BioWorld Regulatory Cancer U.S. FDA

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