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IoM Issues 510(k) Workshop Report

[ Price : $8.95]

The Institute of Medicine issues a report summarizing a workshop held to hear perspectives on FDAs 510(k) premarket clearance prog...

Aranesp Trial Failed to Meet Goals: FDA

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FDA asks its Cardiovascular and Renal Drugs Advisory Committee to comment on the risk/benefit profile of Amgens Aranesp in chronic...

Class 1 Recall on Westmed Resuscitation Device

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FDA classifies as Class 1 a recent Westmed recall involving BagEasy Manual Resuscitation Device.

23% of Docs Wont See Sales Reps

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A physician access survey finds that one-quarter of doctors refuse to see drug sales representatives at their practice locations.

Trial Reporting Changes Sought

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German drug researchers say published trial reports demonstrating efficacy of Pfizers Edronax were misleading because including un...

Congressmen Raise 510(k) Issues for Deeper Consideration

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Twelve members of Congress tell FDA commissioner Hamburg there are five 510(k) reform proposals from FDA that are controversial an...

Bisphosphonate Labeling Gets New Fracture Warning

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FDA says bisphosphonate labeling will be updated with information on rare atypical thigh fractures that may be associated with lon...

FDA To Award Cooperative Agreement to Combat Counterfeits

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Federal Register Notice: FDA will accept a single source application for awarding a cooperative agreement to the World Health Orga...

FDA, NIH Plan Diabetes Workshop

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Federal Register Notice: FDA and the National Institutes of Health plan a public workshop 9/10, Innovations in Technology for the ...

FDA Issues IND Human Studies Guidance

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FDA issues a guidance to help researchers determine whether human studies can be conducted under an IND.