No matter how tumultuous the times, the novel drugs and biologics approved by the US FDA in 2020 show the continuation, and even acceleration of previous themes as the novel drug and biologic class became more weighted toward regulatory incentives and expedited review pathways.
Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune
Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.