FDA describes updates it will make to the inactive ingredient database as required under GDUFA 2.
A New York Times editorial suggests three steps to address problems arising in expedited drug approvals, including extremely high patient costs.
Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Sterilization 21 CFR 801...
FDA approves a Harmony Biosciences NDA for Wakix (pitolisant) for treating excessive daytime sleepiness in adult patients with narcolepsy.
The Medical Device Innovation Consortium, of which FDA is a part, says it is soliciting public comments on a white paper on best practices for communi...
FDA grants accelerated approval for Genentechs Rozlytrek (entrectinib) for treating cancers in patients having the specific genetic defect NTRK gene f...
FDA and Syapse announce a multi-year research effort to look at use of real-world evidence in oncology regulatory decisions.
Federal Register notice: FDA posts a draft guidance on gastroparesis drug development.