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Guidance on Tracing Rx Drugs

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Federal Register Notice: FDA releases a draft guidance on standards for the interoperable exchange of information for tracing cert...

FDA Approves Sanofis Proftin for Latent TB

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FDA approves a Sanofi supplemental NDA for Priftin (rifapentine) in combination with isoniazid for treating latent tuberculosis in...

1 New, 3 Updated REMS

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FDA approves one new and three updated REMS.

QS Problems at Greiner Bio One Brasil Produtos

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FDA warns Brazils Greiner Bio One about Quality System violations in its manufacturing of blood collection tubes.

CGMP Violations Found at Long Island Pharmaceuticals

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FDAs New York District Office warns Long Island Pharmaceuticals about CGMP violations in its manufacturing of dietary supplements....

FDA Clears Stimwave Freedom Spinal Cord Stimulation System

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FDA clears a Stimwave Technologies 510(k) for its Freedom Spinal Cord Stimulation System, a microtechnology neuromodulation device...

AstraZeneca NDA Filed for Iressa in Lung Cancer

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FDA accepts for filing an AstraZeneca NDA for Iressa (gefitinib) as a targeted monotherapy for the first line treatment of patient...

FDA Lifts Clinical Hold on Flexion Arthritis Drug

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FDA lifts a clinical hold on the Phase 2b trial of Flexion Therapeutics FX006 drug candidate to treat osteoarthritis pain.

Guidance on Infusion Pumps

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Federal Register Notice: FDA releases a final guidance: Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Sta...

Guidance on Product Labeling on the Absence of Latex

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Federal Register Notice: FDA releases a guidance: Recommendations for Labeling Medical Products to Inform Users That the Product o...