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Lawyers Critique Guide on Unapproved Use Dissemination

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A Duane Morris client alert analyzes a recent FDA guidance on communicating scientific information to healthcare professionals abo...

Pfizer Seeks Braftovi Full Approval in Colon Cancer

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Pfizer seeks full approval for current accelerated-approved Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFO...

FDA Clears Hearing Aid/Smart Glasses

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FDA clears an EssilorLuxottica 510(k) for its over-the-counter Nuance Audio Glasses that provide an open-ear hearing solution inte...

Gyder Hip System Cleared by FDA

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FDA clears a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during hip replacement s...

Vertex Non-Opioid New Pain Drug Approved

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FDA approves a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a first-in-class non-opioid pain drug for treating moderate ...

Info Collection on Rx Labeling Requirements

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Federal Register notice: FDA sends to OMB an information collection revision entitled Labeling Requirements for Prescription Drugs...

Biosimilar User Fees Info Collection Revised

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Federal Register notice: FDA sends to OMB an information collection revision entitled Biosimilars User Fee Program.

FDA Alert on Fresenius Kabi Infusion Pumps

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An FDA alert advises healthcare providers about Fresenius Kabis Ivenix large-volume pumps and their increased chance of issuing a ...

Neo-Tee T-Piece Resuscitators Recalled

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Mercury Medical recalls its Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from ...

Guide on Reducing Sepsis from Cell/Tissue Products

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FDA posts a final guidance entitled Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by...