Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Sterilization 21 CFR 801...
FDA posts nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal...
FDA approves a Roche a supplemental NDA for Xofluza (baloxavir marboxil) for treating acute uncomplicated influenza in certain children.
Citing lingering questions about pulse oximeters, four Senate Democrats urge FDA to initiate a post market study of the devices.
FDA grants Daiichi Sankyo accelerated approval for Enhertu for treating adult patients with unresectable or metastatic non-small cell lung cancer.
Attorney Sara Koblitz says an Avadel suit against FDA challenges the agency's authority to list some patents in the Orange Book and require certificat...
FDA says its clinical hold on a MaaT Pharma Phase 3 trial of an investigational graft-versus-host disease drug remains in place while the company prov...
Federal Register notice: FDA seeks comments on an information collection extension entitled "Mammography Quality Standards Act Requirements: CFR part ...
