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Litigation Ensures that Tobacco Will Rob Other FDA Programs

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Washington commentator Robert F. Steeves says that predictable industry litigation against FDA tobacco regulation, combined with p...

Changes Made on Tobacco Committee Notice

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Federal Register Notice: FDA amends its notice requesting participants to select representatives for its Tobacco Products Scientif...

Genzymes Campath Combination Achieves Endpoint in CLL Patients

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Genzyme plans filing for approval with FDA for a combination of its Campath with Fludara in patients with relapsed or refractory c...

CDRH to Re-review Menaflex Device Over Compromised 510(k)

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A preliminary report says CDRH will reevaluate its 510(k) clearance decision on ReGen Biologics controversial Menaflex Collagen Sc...

Grant Awarded to Study Mammary Cancer Susceptibility

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Federal Register Notice: FDA announces the availability of grant funds to support a Cooperative Agreement Award to Georgetown Univ...

Does CDRH Need to Revamp 510(k) Process? IoM to Study

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FDA commissions an Institute of Medicine study to decide whether it is time to revamp CDRHs 510(k) substantially equivalent cleara...

Advisors Generally Support Exalgo Use

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Members of FDAs Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee sa...

Wyeth Sues FDA Over Incompatible Generic Zosyn

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Wyeth sues FDA seeking an order rescinding its recent approval of Orchid Healthcares generic version of Zosyn because it cannot be...

FDA Proposes cGMPs for Combination Products

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Federal Register Proposed rule: FDA proposed to codify current good manufacturing practice requirements for combination products.

CDRH Ombudsman Denies Amalgam Dispute Resolution Bid

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Using inapposite citations, CDRHs ombudsman denies a lawyers request that the controversial mercury dental amalgam final rule be r...