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FDA Guidance on Essure-type Device Labeling and Warnings

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FDA releases a guidance on Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization that addresse...

FDA Clears Corindus New CorPath Vascular Robotic System

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FDA clears a Corindus Vascular Robotics 510(k) for the CorPath GRX, the second generation of its CorPath Vascular Robotic System.

Emergency Use Authorization Given to 4 Zika Tests

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Federal Register Notice: FDA announces the issuance of Emergency Use Authorizations for four in vitro diagnostic devices for detec...

FDA Complete Response on Sanofi/Regenerons Arthritis Therapy

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FDA sends Regeneron Pharmaceuticals and Sanofi a Complete Response Letter on their BLA for sarilumab, an investigational interleuk...

HeartWare Recalls Ventricular Assist Device

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HeartWare Inc. begins a Class 1 recall of its Ventricular Assist Device controller due to a loose power connector which may cause ...

Legislative MDUFA 4 Changes

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A summary of draft legislation shows funding changes under the MDUFA 4 agreement.

Improving Real-World Evidence Guidance

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Two stakeholders suggest ways to improve an FDA draft guidance on using real-world evidence in medical device regulatory decision-...

Partial Clinical Hold on AstraZeneca Durvalumab Trial

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FDA places a partial clinical hold on AstraZenecas enrollment of new patients with head and neck squamous cell carcinoma in clinic...

Cut TPP Biologics Exclusivity Extension: Groups

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Five organizations call on President Obama to reduce the 12-year market exclusivity period to seven years for biologic drugs in an...

FDA Approves Roche Assay for New Lung Cancer Therapy

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FDA approves a Roche PMA for the Ventana PD-L1 (SP142) Assay as a complementary diagnostic to identify PD-L1 expression levels in ...