The Institute of Medicine's drug safety committee came down hard on FDA's efforts to make sure drugs they approve are safe and effective. But FDA dodged a bullet based on what isn't in the report.
By Ramsey Baghdadi
"I am so tired of people saying that FDA is a train wreck waiting to happen," Food & Drug Administration...
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Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
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.
The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.
Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.
