Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.

Most of the new Genetic Metabolic Diseases Advisory Committee members have little FDA or advisory committee experience, except the new industry representative, with six more voting slots still to fill before its first meeting.

With sales of its big sellers Jardiance and Ofev to start shrinking in the next few years, the German group is teeing up a suite of new drugs.

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.