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FDA Shakeup: Galson Leaves, Woodcock Back to CDER

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As if to clear the CDER decks for the new FDA law's implementation, the Bush Administration elevates Center director Steven Galson...

FDA Preemption Could Limit Consumer Suits

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An Accuracy in Media online column details arguments made before the Senate Judiciary Committee supporting and opposing FDAs preem...

Import Safety Legislation Introduced

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Rep. John Dingell and others introduce legislation to strengthen FDAs inspection of food and drug imports.

People Trust FDA, Unsure if it Performs Well

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An American University survey says consumers trust FDA more than any other organization on prescription drug issues but arent sure...

Campath Indication Expanded

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FDA approves an expanded indication for Genzymes Campath as a single agent for treating B-cell chronic lymphocytic leukemia.

Trial Lawyers Win Anti-preemption Language in FDA Bill

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Trial lawyers smell a victory after Democrats insert anti-preemption language in the compromise FDA Revitalization Act (FDARA).

FDA Clears RSP Spines Interplate for Cervical/Lumbar Use

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FDA clears a RSB Spine 510(k) for the InterPlate cervical and lumbar device for use in intervertebral fusion procedures.

FDA Proposes End to CFCs in Metered-dose Inhalers

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FDA proposes eliminating CFCs in OTC epinephrine metered-dose inhalers.

Advisors Recommend Repel-CV for Pediatric Use

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FDAs Circulatory System Devices Advisory Panel recommends FDA approve SyntheMeds Repel-CV for pediatric use.

FDA Sends Info on Device QSRs to OMB

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Federal Register Notice: FDA submits a proposed collection of information on Quality System Regulations for medical devices.