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FDA Downplays Contaminated ARBs Exposure

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CDER director Janet Woodcock says the number of people actually exposed to contaminated angiotensin I receptor blockers is likely ...

Objections, Support for FDA Drug Regulatory Modernization

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Public Citizen and PhRMA air their disagreement over an FDA proposal to use integrated review documents in communications about ne...

FDA Clears 4Web Interbody Fusion Device

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FDA clears a 4Web Medical 510(k) to market its Cervical Spine Truss System-Stand Alone interbody fusion device.

Support for Heart Failure Endpoints Guidance

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Five stakeholders offer supporting comments on an FDA draft guidance on endpoints for developing drugs to treat heart failure.

Comments Reopened on Dronabinol Scheduling

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Federal Register notice: FDA reopens the comment period for a 3/1 notice on international drug scheduling for Dronabinol.

Biobeat Patch/Watch for Monitoring Vitals Cleared

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FDA clears a Biobeat 510(k) for its patch and watch for measuring blood pressure, oxygenation and heart rate in hospitals, clinics...

Final Guide on Placebos/Blinding in Cancer Trials

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FDA releases a final guidance on use of placebos and blinding in cancer clinical trials.

Viela Bio BLA for Rare Autoimmune Disorder

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FDA accepts for review a Viela Bio BLA for inebilizumab, an investigational anti-CD19 monoclonal antibody for treating patients wi...

Safety Alert on Hep C Protease Inhibitors

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FDA issues a safety alert on three chronic hepatitis drugs after some patients with moderate to severe liver impairment experience...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes CTX Lifesciences and Ningbo Pulisi Daily Chemical Products.