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An Associated Press analysis says FDA is overdue on some 2,000 drug company facilities that havent been inspected since before the...[ Price : $8.95]
FDA asks its Antimicrobial Drugs Advisory Committee whether an Iterum NDA for sulopenem etzadroxil/probenecid to treat some uncomp...[ Price : $8.95]
Biosimilars Forum asks FDA for further information and clarification on certain areas of the agencys recent draft guidance entitle...[ Price : $8.95]
FDA publishes a revised guidance on controlling nitrosamine impurities in human drugs.[ Price : $8.95]
Baxter recalls (Class 1) certain Volara Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to reports that the...[ Price : $8.95]
Federal Register notice: FDA determines that Pfizers Flagyl (metronidazole) tablets, 250mg and 500mg, were not withdrawn due to sa...[ Price : $8.95]
Two industry associations give line-by-line comments and edits on an International Council for Harmonization draft guidance on the...[ Price : $8.95]
The American Clinical Laboratory Association and its fellow plaintiffs ask a Texas federal court to grant summary judgment in favo...