FDAs Cardiovascular and Renal Drugs Advisory Committee votes against recommending approval for a FibroGen NDA for roxadustat, indicated for treating a...
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam.
FDA follows a Warning Letter to Jubilant Pharmovas Roorkee facility with an import alert.
Members of the FDA Gastroenterology and Urology Devices Panel vote to support TransMedics OCS liver system with a likely indication for use with organ...
Federal Register notice: FDA sends to OMB a proposed information collection entitled Medical Conference Attendees Observations About Prescription Drug...
Arnold & Porter attorneys give practical tips for attempting to include real-world evidence in advertising for medicinal products.
Winston & Strawn attorneys outline an FDA draft guidance on the enhanced Drug Supply Chain Security Act system for tracking and tracing drugs at the p...
Emergent Biosolutions responds to an FDA-483 about issues at its Bayview facility that manufactured Covid-19 vaccines and was the subject of a cross-c...