FDA asks its Antimicrobial Drugs Advisory Committee whether an Iterum NDA for sulopenem etzadroxil/probenecid to treat some uncomplicated urinary trac...
Biosimilars Forum asks FDA for further information and clarification on certain areas of the agencys recent draft guidance entitled Purpose and Conten...
FDA publishes a revised guidance on controlling nitrosamine impurities in human drugs.
Baxter recalls (Class 1) certain Volara Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the components handset ...
Federal Register notice: FDA determines that Pfizers Flagyl (metronidazole) tablets, 250mg and 500mg, were not withdrawn due to safety or effectivenes...
Two industry associations give line-by-line comments and edits on an International Council for Harmonization draft guidance on the planning, design, a...
The American Clinical Laboratory Association and its fellow plaintiffs ask a Texas federal court to grant summary judgment in favor of its suit challe...
FDA warns Chula Vista, CA-based SoloVital it is marketing a misbranded and unapproved hyaluronic acid drug product as a dietary supplement.
