Five stakeholders offer supporting comments on an FDA draft guidance on endpoints for developing drugs to treat heart failure.
Federal Register notice: FDA reopens the comment period for a 3/1 notice on international drug scheduling for Dronabinol.
FDA clears a Biobeat 510(k) for its patch and watch for measuring blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and...
FDA releases its latest batch of Warning Letters that includes CTX Lifesciences and Ningbo Pulisi Daily Chemical Products.
Attorney Anne Walsh says regulated companies may cite a recent Supreme Court decision when challenging the notion of judicial deference to FDAs interp...
Federal Register notice: FDA makes available a draft guidance entitled Male Breast Cancer: Developing Drugs for Treatment.
A recently posted Establishment Inspection Report involving AveXis Zlogensma, which is behind a data manipulation investigation, shows an extensive re...
CDER Office of Antimicrobial Products director Edward Cox leaves FDA to join Regeneron as regulatory affairs vice president.