FDA says it is interested in working with Congress to find a legislative solution, most likely a bill that would be added to the user fee reauthorization package that is moving through Congress, to help overturn a 2021 appeals court decision (Catalyst Pharmaceuticals v. Becerra) that has disrupted FDA’s orphan drug program.
Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representative to serve on the agency’s Pediatric Advisory Committee.
Attorney Bryan Feldhaus says the revised FDA intended use regulation clarifies but does not change the definition of intended use and should not adversely affect off-label communications.