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More Evidence of Political Meddling in Coronavirus: Subcommittee

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The House Select Subcommittee on the Coronavirus Crisis says it has found additional evidence of the Trump administrations politic...

FDA Lists Veterinary Regenerative Medicine Studies

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FDA publishes a Web page with listings of clinical field studies of animal cells, tissues, and cell- and tissue-based products.

Hold 3rd-Party Device Servicers Accountable: MITA

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The Medical Imaging and Technology Alliance says FDA should exercise greater oversight over third-party medical device servicing o...

Corrigan-Curay on Detail on CDER Directors Office

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CDER Office of Medical Policy director Jacqueline Corrigan-Curay begins a detail to the Office of the Center Director as deputy di...

Appeals Court to Re-Hear Teva Skinny Label Case

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The U.S. Court of Appeals for the Federal Circuit says it will reconsider a 2020 decision to uphold a jury award of $235 million t...

Report Analyzes False Claims Act Enforcement Developments

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A Hogan Lovells False Claims Act enforcement report says the new Biden administration and a priority on coronavirus cases will lea...

CBER Advanced Technologies Team Created: Report

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An annual report from CBER director Peter Marks outlines 2020 activities, including the Centers new Advanced Technologies Team tha...

CDRHs Pena Leaves FDA to Join Jacobs Institute

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CDRH Office of Neurological and Physical Medicine Devices director Carlos Pena leaves the agency to develop the newly established ...

Roche Breakthrough Status for Companion Diagnostic

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FDA grants Roche a breakthrough device designation for its Elecsys GDF-15 assay as a companion diagnostic in cancer treatment.

Supernus Resubmits NDA for ADHD Drug

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Supernus Pharmaceuticals refiles its NDA for SPN-812 for treating ADHD in pediatric patients.