FDA approves a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bone tumor in the leg.
Federal Register notice: FDA extends the comment period for a 10/13 notice announcing a public meeting and requesting comments on a potential revised ...
Federal Register notice: FDA makes available a final guidance for industry #242 entitled In-Use Stability Studies and Associated Labeling Statements f...
FDA makes available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, a...
FDA Review posts the Federal Register notices for the week ending 11/27/2020.
Federal Register notice: FDA orders the permanent debarment of Michael L. Babich from providing services in any capacity to a person that has an appro...
An FDA complete response letter tells Liquidia the agency needs more CMC data on the companys LIQ861 inhalation powder to treat pulmonary arterial hyp...