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Unbranded Ads Becoming More Prevalent

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Sanofi-Aventis gets 400,000 people in one week to visit a Web site tied to its unbranded Silence Your Rooster DTC campaign.

Info on Accredited Persons Inspections Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on requests for inspections under the accredited person pr...

CareToLive Loses Provenge Appeal

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The Sixth Circuit Court of Appeals affirms a lower federal courts ruling that it lacked jurisdiction to approve a CareToLive reque...

FDA Complete Response Letter on BioDeliverys Fentanyl

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FDA issues BioDelivery Sciences International a complete response letter on its NDA for Onsolis (fentanyl buccal soluble film).

Guidance on Integrated Summary of Effectiveness

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Federal Register Notice: FDA releases a draft guidance on an integrated summary of effectiveness.

Group Says FDAs Pregnancy Labeling Proposal is Weak

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Public Citizen says FDAs revamped pregnancy labeling approach for drugs and biologics falls short in providing adequate public hea...

Scholars Set 9 Steps to Rescue Science from Politics

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Center for Progressive Reform scholars call for nine concrete changes to stop what they see as political attacks on science and sc...

Ortho to Appeal Razadyne Patent Ruling

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Ortho-McNeil Neurologics says it will appear a federal judges ruling that its Razadyne patent is invalid.

Hi-Tech Sues FDA for Generic Cosopt Exclusivity

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Hi-Tech Pharmacal asks a federal court to declare the company is entitled to 180 days of marketing exclusivity for a generic form ...

FDA Clears HemosIL D-Dimer Assay

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FDA clears an Instrumentation Laboratory 510(k) for the HemosIL D-Dimer assay to rule out venous thromboembolism in outpatients wi...