Obesity Advocates Meet With FDA Commissioner, Push On Difference vs. Short-Term Weight-Loss

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.

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.