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. These so-called action packages are prepared by individual agency teams as part of their reviews of marketing applications for new medicines.
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