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Guidance on Limiting Phthalates as Excipients

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A CDER guidance recommends against using DBP and DEHP as excipients in drug and biologic products.

CDER Denies Generic Copaxone Restriction Request

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FDA denies a Teva petition seeking limitations on approving generic forms of Copaxone without comment on specific requirements it ...

Reviewers Question Zohydro ER Abuse Potential

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CDER medical reviewers say they believe that Zogenix Zohydro ER may be more subject to abuse than combination hydrocodone products...

Chelsea Therapeutics: Positive Results in Parkinsons Trial

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Chelsea Therapeutics International reports positive preliminary results for Study 306B, a Phase 3 trial evaluating Northera for tr...

CDRH Lists 6 Strategic Priorities

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CDRH releases its six strategic priorities for 2013.

FDA, AstraZeneca Agree on Faslodex Label Update

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FDA and AstraZeneca reach agreement on label changes for Faslodex injection that updates results from the companys CONFIRM trial i...

FDA Approved 35 NMEs in 2012

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An FDA report discusses the 35 new molecular entities the agency approved in FY 2012.

Lawyers Examine Future of FDA Enforcement Actions

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Lawyers from Skadden and Foley Hoag examine the future of FDA and Justice Department enforcement actions in the wake of this weeks...

FDA, Peregrine Reach Agreement on Brain Cancer Trial

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FDA and Peregrine Pharmaceuticals reach agreement on the design of a single registration drug trial for Cotara in patients with re...

FDAs Staggering Strategic Blunder in Off-label Case

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FDA Webview editor Jim Dickinson analyzes FDAs loss of a potent off-label drug marketing case, calling it a staggering strategic b...