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Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam....[ Price : $8.95]
FDAs Cardiovascular and Renal Drugs Advisory Committee votes against recommending approval for a FibroGen NDA for roxadustat, indi...[ Price : $8.95]
FDA follows a Warning Letter to Jubilant Pharmovas Roorkee facility with an import alert.[ Price : $8.95]
Members of the FDA Gastroenterology and Urology Devices Panel vote to support TransMedics OCS liver system with a likely indicatio...[ Price : $8.95]
Federal Register notice: FDA sends to OMB a proposed information collection entitled Medical Conference Attendees Observations Abo...[ Price : $8.95]
Arnold & Porter attorneys give practical tips for attempting to include real-world evidence in advertising for medicinal products.[ Price : $8.95]
Winston & Strawn attorneys outline an FDA draft guidance on the enhanced Drug Supply Chain Security Act system for tracking and tr...[ Price : $8.95]
Emergent Biosolutions responds to an FDA-483 about issues at its Bayview facility that manufactured Covid-19 vaccines and was the ...