FDA Wants To Release “Masked” Marketing Application Data To Researchers

FDA is seeking public feedback on a proposal to make masked and de-identified clinical trial safety and efficacy data from marketing applications available to outside parties for further analysis.

FDA is considering releasing masked and de-identified clinical trial safety and efficacy data from marketing applications to outside researchers and other non-FDA experts.

In a June 4 Federal Register notice, FDA called for public comments on its proposal to make available clinical and pre-clinical data. The proposal fits in with on-going...

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