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FDA Releases 3 Draft Guidances on Drug Compounding

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Within days of President Obama signing the Drug Quality and Security Act, FDA posts three draft guidances on pharmacy drug compoun...

Baxter Submits Amended BLA for HyQvia

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Baxter International files an amended BLA for HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase] f...

Orphan Status for Liver Transplant Drug

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FDA grants Conatus Pharmaceuticals an orphan drug designation for emricasan and its use in treating liver transplant recipients wh...

Sumitomo Proton Therapy System Clears FDA 510(k)

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FDA grants 510(k) clearance to Sumitomo Heavy Industries for its Proton Therapy System to kill cancer cells.

Info on Medically Necessary Products Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget in a guidance on ...

Abbott Recalls FreeStyle Blood Glucose Strips

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Abbott recalls 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood gl...

FDA Accepts NDA for Zalviso Pain System

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FDA accepts for review an AcelRx Pharmaceuticals NDA for Zalviso (sublingual sufentanil microtablets), a patient-controlled treatm...

FDA Extends Review for Biogen Clotting Factor

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FDA extends by three months its review of a Biogen Idec BLA for Alprolix, an investigational long-lasting recombinant factor IX Fc...

Info on Drug Product Focus Groups Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on focus groups a...

Comments Sought on Device Adverse Event Info

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Federal Register Notice: FDA seeks comments on a proposed collection of information on the device adverse event program.