The Makena Deciders: FDA Commissioner Califf, Chief Scientist Bumpus To Jointly Make Final Call On Drug’s Fate

The two senior agency officials will render the decision together as co-signatories on whether Makena loses its accelerated approval or is allowed to stay on the market; that decision will not come before mid-January, and is likely to be weeks or months later, based on a timeline set out by hearing officer Celia Witten.