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Federal Register Notice: FDA releases a draft guidance on standards for the interoperable exchange of information for tracing cert...[ Price : $8.95]
FDA approves a Sanofi supplemental NDA for Priftin (rifapentine) in combination with isoniazid for treating latent tuberculosis in...[ Price : $8.95]
FDA warns Brazils Greiner Bio One about Quality System violations in its manufacturing of blood collection tubes.[ Price : $8.95]
FDAs New York District Office warns Long Island Pharmaceuticals about CGMP violations in its manufacturing of dietary supplements....[ Price : $8.95]
FDA clears a Stimwave Technologies 510(k) for its Freedom Spinal Cord Stimulation System, a microtechnology neuromodulation device...[ Price : $8.95]
FDA accepts for filing an AstraZeneca NDA for Iressa (gefitinib) as a targeted monotherapy for the first line treatment of patient...[ Price : $8.95]
FDA lifts a clinical hold on the Phase 2b trial of Flexion Therapeutics FX006 drug candidate to treat osteoarthritis pain.