A U.S. Supreme Court decision makes it easier for FDA and other government agencies to shield companies supposed commercial/confidential information f...
FDA releases a list of 20 guidances it expects to work on during 2019.
FDA expands the approval of Regenerons Dupixent (dupilumab) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis.
FDA solicits public comment on two new efforts to increase transparency in drug regulatory approvals.
FDA publishes a guidance for manufacturers seeking marketing clearance for diagnostic ultrasound systems and transducers.
FDA posts a draft guidance entitled E19 Optimization of Safety Data Collection.
FDA issues a draft guidance with recommendations on clinical investigations for prostate tissue ablation devices.
Federal Register notice: FDA is seeking comments on an information collection extension related to a guidance on Administrative Procedures for Clinica...