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FDA Approves Medtronic Indication for Onyx Stents

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FDA approves two Medtronic drug-eluting stents for use in treating non-left main bifurcation lesions in the heart.

FDA Clears AI Colon Polyp Detector

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FDA clears an Iterative Scopes 510(k) for SKOUT, a computer-aided polyp detection device for adults undergoing colorectal cancer s...

User Fee Reauthorization Agreement Reached in Senate

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Senate Health, Education, Labor and Pensions Committee leaders reach agreement to reauthorize FDAs user fee programs for an additi...

Lillys Retevmo Gains Regular FDA Approval

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FDA grants regular approval to Eli Lilly for its previously accelerated-approval Retevmo (selpercatinib) for treating certain adul...

Accelerated Approval On- and Off-Ramp Approaches

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Staff in the FDA Oncology Center of Excellence say ways must be found to improve studies leading to accelerated approval to shorte...

Panel Votes Down Spectrum Lung Cancer Drug

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FDAs Oncologic Drugs Advisory Committee votes 9-4 against recommending accelerated approval for Spectrum Pharmaceuticals Pozenveo ...

DoJ Increasing Corporate Enforcement

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Former U.S. Attorney Gregory Brower discusses four takeaways from a recent Department of Justice memo on increased corporate enfor...

Guide on Drug Covered Product Authorizations

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FDA posts a draft guidance entitled How to Obtain a Covered Product Authorization for generic drug developers having trouble getti...

Rx NIX Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that GlaxoSmithKlines prescription-only NIX (permethrin) 1% topical creme rinse was not wi...

5 Observations in Cipla FDA-483

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FDA releases a form FDA-483 with five observations from an inspection at the Cipla drug manufacturing facility in Goa, India.