Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, at left, and his predecessor, Peter Marks, at right.FDA

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

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In the context of a rare and progressively fatal disease for which there are no available treatments…

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Is it better to approve a drug with undetermined or debatable benefits that is later found not to be effective?

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