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FDA Updates Device Cybersecurity Activities

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FDA says it is preparing a significant update to its guidance on Content of Premarket Submissions for Management of Cybersecurity ...

Special 510(k) Pilot Program Begins 10/1

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FDA launches a revised Special 510(k) Pilot Program that aims to expand on the types of changes eligible for the program to improv...

Former Able Labs Quality Manager Debarred

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Federal Register notice: FDA denies a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years...

Draft Guide on Human Factors Subsmissions

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FDA issues a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Dru...

FDA Reclassifies Single-use Female Condoms

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Federal Register notice: FDA issues a final order to reclassify single- use female condoms, renaming the device to single-use inte...

FDA Draft Guides on Adaptive Trials and Master Protocols

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FDA issues two new draft guidance documents one on adaptive clinical trial designs and the other on master protocols that propos...

Pfizers Vizimpro Approved for Lung Cancer

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FDA approves Pfizers Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of certain patients with metastatic n...

Sens. Hatch, Bennet Bill on Updating Drug Labels

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Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) introduce Making Objective Drug Evidence Revisions for New(MODERN) Labeling ...

FDA Clears Next Gen Sequencing Assay

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FDA clears a de novo request to permit the marketing of Adaptive Biotechnologies ClonoSEQ assay, a next-generation sequencing-base...

Guide on Outsourcing Facility Adverse Event Reporting

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FDA releases a final guidance entitled Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, ...