Up Is Down — Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval – nejm.org

Nine pharmaceutical company leaders took the unprecedented step on September 8, 2020, of stating that they would refuse to apply for approval of a Covid-19 vaccine until adequate trial data are available.1 This announcement reflected an unusual role reversal at a time of unexpected regulatory anomalies. For decades, manufacturers have criticized the Food and Drug Administration (FDA) for being too slow and demanding too much evidence before approving new products. But in the face of growing publ…

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