FDA approving drugs at breakneck speed, raising alarm

Bloomberg

7 December 2019 - Breakthrough products beating deadlines by weeks, even months.

The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer advocates.

Global Blood Therapeutics, maker of a new sickle cell disease drug called Oxbryta, built a booth to showcase the medicine at the annual meeting of the American Society of Hematology that begins this weekend -- even though the Food and Drug Administration’s deadline for approval was 26 February.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Regulation , Timelines