STAT+: Pharmalittle: Califf has lots of unfinished FDA business; FDA’s warnings prompt trial sponsors to report results

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-predictable routine of meetings, online calls, and deadlines is upon us once again. To cope, yes, we are brewing a cup of stimulation. Our choice, for those who track this sort of thing, is ginger spice. Goes well with a slice of pumpkin challah toast and fig butter, too. Meanwhile, here are a few tidbits to get you going in case you are out of fig butter. Hope you have a smashing day and, as always, do stay in touch. We cherish your postcards. …

Robert Califf, whom President Biden picked to lead the US. Food and Drug Administration, does not have much to show for his first tenure at the agency, STAT notes. The former FDA commissioner had grand plans for modernizing the way drug makers and the FDA collect patient data, but the notion was shelved in 2017 after he left the agency. His efforts to ban flavored tobacco products were foiled by the Obama White House. Even his push to finally fix FDA hiring woes still has not been fully implemented. Former FDA officials and Califf allies at the agency are clear: He has plenty of unfinished business that he will want to tackle as soon as he is confirmed.

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