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FDA Cautions on Heater-Cooler Device Infections

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FDA advises healthcare professionals and facilities to be aware of the patient risk involved in infections associated with use of ...

FDA, Industry Offer PDUFA Reauthorization Perspectives

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FDA says the reauthorization of the Prescription Drug User Fee Act program should include enhancements to the review processes, re...

Lannett Gains FDA Approval of Generic Alzheimers Drug

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Lannetts wholly owned subsidiary, Silarx Pharmaceuticals, gains FDA approval of generic copy of Forest Pharmaceuticals Alzheimers ...

FDA Clears Pantheris Image-guided Atherectomy System

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FDA clears an Avinger 510(k) for its Pantheris image-guided atherectomy system and its use in treating patients with peripheral ar...

Researchers Say Essure Has Higher Risk of Operation

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Weill Cornell Medicine researchers say their study of patient data indicates a 10 times greater risk of a follow-up operations for...

Guidance on Animal Studies for Medical Devices

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Federal Register Notice: FDA releases a draft guidance: General Considerations for Animal Studies for Medical Devices.

Guidance on Microbial Vectors Used for Gene Therapy

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Federal Register Notice: FDA releases a draft guidance: Recommendations for Microbial Vectors Used for Gene Therapy.

FDA Says Ampio Needs Optina Confirmatory Study

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FDA tells Ampio Pharmaceuticals that it should conduct a small Optina confirmatory study in patients with diabetic macular edema.

Senators Want More Open Payment Reporting

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Sens. Grassley and Blumenthal propose legislation to expand Sunshine Act payment reporting requirements to cover nurse practitione...

Duchenne Drugs Heading to Advisory Committee Reviews

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FDA says two drugs for treating Duchenne muscular dystrophy are heading to advisory committee reviews.