Califf on ac­cel­er­at­ed ap­provals: Com­pa­nies need to do more work be­fore FDA says OK

As he awaits a tight Sen­ate vote, Rob Califf, Pres­i­dent Joe Biden’s nom­i­nee to be the next FDA com­mis­sion­er, is sig­nal­ing where the agency may move on ac­cel­er­at­ed ap­provals if he takes over at FDA.

Build­ing off com­ments from his Sen­ate con­fir­ma­tion hear­ing, in which Califf said that he’s “a fan of ac­cel­er­at­ed ap­proval” but the US needs a bet­ter sys­tem to eval­u­ate these drugs once they’re on the mar­ket, the nom­i­nee raised ques­tions about how well the cur­rent struc­ture serves pa­tients.

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