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Direct Device Marking Guidance

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FDA issues a guidance answering questions about the direct marking of medical devices under the unique device identification regul...

Leave Battlefield Medical Decisions to FDA: Senate Vote

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The Senate approves a House bill retaining FDA authority over battlefield drug and medical device decisions.

Genentechs Gazyva OKd for Advanced Follicular Lymphoma

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FDA approves Genentechs Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, f...

Bone Drugs Panel to Review Lipocine Testosterone NDA

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Federal Register notice: FDA announces a 1/10/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting that will disc...

Final Decision on Mepergan Fortis sNDA Administrative Review

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Federal Register notice: FDA announces that an initial decision of the administrative law judge (ALJ) is now the final agency deci...

Draft Guide on GRAS Panel Best Practices

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Federal Register notice: FDA makes available a draft guidance on Best Practices for Convening a GRAS Panel.

FDA on Schedule with Sunscreen Innovation Act: GAO

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The Government Accountability Office says FDA has properly implemented the 2014 Sunscreen Innovation Act in the time frames set by...

FDA Approves Hemlibra for Hemphilia A Bleeding

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FDA approves Genentechs Hemlibra for preventing or reducing the frequency of bleeding episodes in those with hemophilia A.

FDA OKs Expanded Approval for Pfizers Sutent

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FDA approves Pfizers Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cance...

Alkermes NDA for Add-on Therapy for Aristada

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FDA accepts an Alkermes NDA for aripiprazole lauroxil nanocrystal dispersion (ALNCD) as an add on therapy with its Aristada (aripi...