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Draft Guide on Master Protocol Trial Designs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guide entitled Master Protocols: Efficient Clinical Trial Design Strategies t...

Oscor Recalls TB Bipolar Pacing Leads

[ Price : $8.95]

Oscor Inc. recalls its TB Temporary Bipolar Pacing Lead (unshrouded 2 mm Pins Models) due to connectivity concerns.

Ventana Class 1 Recall of Detection Kits

[ Price : $8.95]

Ventana Medical Systems recalls (Class 1) multiple detection kits due to a potential for false negative results caused by reagent ...

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FDA issues a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Dru...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FDA issues two new draft guidance documents one on adaptive clinical trial designs and the other on master protocols that propos...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...