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Lawmakers Push for UDIs on Insurance Forms

[ Price : $8.95]

Five bipartisan members of Congress ask HHS and CMS to include unique device identifiers on health insurance claims forms to enhan...

Nubratori Rx FDA-483

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FDA releases the FDA-483 with three observations from an inspection at Nubratori, Inc.

Immunomedics Re-files for Breast Cancer Therapy

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Immunomedics resubmits its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients wit...

Judicial Deference to FDA More Uncertain: Analysis

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A Ropes&Gray legal analysis says a recent Supreme Court decision could make it easier for regulated companies to argue against cou...

3rd Circuit Remands Hundreds of Fosamax Cases

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The 3rd Circuit Court of Appeals asks a New Jersey federal court to look at hundreds of Fosamax bone fracture cases and determine ...

NeuroOne Thin Film Brain Electrode Cleared

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FDA clears a NeuroOne Medical Technologies 510(k) to market its thin film cortical electrode technology for temporary (less than 3...

Immunomedics Re-files for Breast Cancer Therapy

[ Price : $8.95]

Immunomedics resubmits its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients wit...

Reg Review Period for Ultragenyxs Crysvita

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Crysvita.

Guide on Clinical Trial Adaptive Designs

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FDA releases a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.

Impella Heart Pump Survival Data Favorable: FDA

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FDA says that most recent, interim post-approval study results for the Impella RP System continue to show a favorable survival ra...