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FDA Stepping Up Drug Inspections in India

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FDA says its inspections in India are nearing pre-pandemic levels.

Getting Clinical Outcome Assessments into Endpoints Guide Coming

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CDER associate director Theresa Mullin says FDA will soon release a draft guidance on Incorporating Clinical Outcome Assessments i...

Vanda Agrees to Pay Over $11 Million in Off-label Suit

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Vanda Pharmaceuticals agrees to settle an off-label marketing case for $11.5 million.

Researcher Convicted in FDA False Statement Case

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A federal jury convicts former clinical researcher for making a false statement to a government investigator related to her role i...

DoJ Renews Individual Accountability Interest in Prosecutions

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The Department of Justice says its top priority for corporate criminal enforcement is individual accountability by targeting the i...

FDA Seeks Patient Advocates for Regulatory Forum

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Federal Register notice: FDA seeks patient advocate applications to participate under its collaboration with the Clinical Trials T...

Roches Endep Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Hoffmann-La Roches Endep (amitriptyline HCl) was not withdrawn from sale for safety o...

FDA Clears New Roche cobas Diagnostic Platform

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Roche gains FDA 510(k) clearance for the cobas pure integrated solutions, the next generation of its cobas diagnostics platform.

ClearPoint Neuro Navigation Software Cleared

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FDA clears a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software.

FDA Reminds on Endotracheal Tube Obstructions

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CDRH updates a 4/27 letter to health care providers to ensure those in operating room settings are aware of a Medtronic recall of ...