FDA updates summary table forms for ANDA submissions containing clinical endpoint studies.
FDA grants BioDirection a breakthrough device designation for its Tbit System for the prediction of positive computerized tomography scans following a...
FDA issues 12 Warning Letters and 5 online advisory letters to companies that are illegally selling more than 58 products that are unapproved or misbr...
FDA grants Amplyx Pharmaceuticals an orphan drug designation for APX001 and its use for treating cryptococcosis.
FDA Review posts the Federal Register notice for the week ending 2/8/2019.
FDA Review posts product approval summaries for the week ending 2/8/2019.
Federal Register notice: FDA requests nominations for nonvoting industry representatives to serve on its public advisory committees for CDER.
Federal Register notice: FDA submits to OMB an information collection extension for its Generic Drug User Fee Coversheet.