Federal Register notice: FDA renews its Medical Imaging Drugs Advisory Committee for an additional two years.
FDA issues a draft guidance with recommendations for sponsor collection of a core set of patient-reported clinical outcomes in cancer clinical trials.
Federal Register notice: FDA announces that eight information collections have recently been approved by OMB.
FDA releases a summary of the Neurological Devices Panel discussion on the classification of six unclassified, preamendments medical devices.
FDA approves a Vertex Pharmaceuticals supplemental NDA for Trikafta (elexacaftor/tezacaftor/ivacaftor) to include certain children with cystic fibrosi...
FDA and HHS release a report with recommendations for strengthening the nations pharmaceutical supply chain.
Two Tellus Clinical Research clinical trial staff plead guilty to charges they falsified trial data.
FDA says two government agencies should enhance their efforts in the area of operational technology cybersecurity.