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Comments on Magnetic Resonance Labeling Guidance

[ Price : $8.95]

Three stakeholders recommend improvements to an FDA draft guidance on testing and labeling medical devices for safety in the magne...

Medtronic MiniMed Pump Recall is Class 1

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FDA says a Medtronic recall of its MiniMed insulin pumps due to potential cybersecurity risks is Class 1.

Warren, Murray Want More Device Approval Answers

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Sens. Warren and Murray raises objections to and questions about an FDA proposal for a progressive approval pathway for medical de...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes one medical product company Bingbing Pharmaceutical.

Abbott Recalls CentriMag Circulatory Support System

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Abbott recalls its CentriMag Acute Circulatory Support System due to a calibration system error.

Aveo Planning Tivozanib NDA Despite FDA Objections

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FDA says a requested clinical trial did not alleviate an overall survival trend that it was concerned with in an earlier Aveo Onco...

Aquestive Therapeutics Asks Approval Stay for Valtoco

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Aquestive Therapeutics asks FDA not to approve Neurelis Valtoco until the company performs additional studies like those Aquestive...

Tonix Changes Tonmya Phase 3 Study

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Tonix Pharmaceuticals says that after receiving input from FDA, it is changing elements of its Phase 3 study of its Tonmya PTSD tr...

Abernathy Overhauling FDA Tech Infrastructure: Politico

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FDA principal deputy commissioner Amy Abernathy says the agency is overhauling its technology infrastructure to be prepared to cop...

FDA Updates Essure Post-Market Activities

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FDA updates its online records on post-market activities and studies of Bayers withdrawn Essure birth control device.