Academics and consumer groups protest FDA plan to summarise review documents

Stat News

29 August 2019 - A Food and Drug Administration proposal to substitute detailed reviews of new drugs written by specific agency teams with an abbreviated summary is prompting strong protests from academic researchers and public advocates who claim the move is “ill conceived” and will harm public health.

Last June, the FDA issued a notice describing plans to do away with a longstanding practice of posting on its website separate reviews concerning pharmacology, medical chemistry, risk assessment, and biostatistics issues, among other things.

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Michael Wonder

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Michael Wonder