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Public Meeting on IT Resources in Reviewing NDAs

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Federal Register Notice: FDA plans a public meeting 10/19 to discuss applying information technology resources to support the revi...

Cephalon Submits Treanda NDA

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Cephalon submits an NDA to FDA for Treanda for treating patients with chronic lymphocytic leukemia.

FDA OKs Novo Nordisk NDA for Turner Syndrome

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FDA approves a Novo Nordisk NDA for Norditropin for treating children with short stature associated with Turner syndrome.

Von Eschenbach on FDA Values and Vision

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An all-hands Webcast by FDA commissioner Andrew von Eschenbach attempts to rally the troops as the agency begins to plan for new a...

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.

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.