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Zibotentan Prostate Cancer Trial Fails

[ Price : $8.95]

AstraZeneca says a Phase 3 trial of its zibotentan in men with metastatic castration-resistant prostate cancer did not meet its pr...

FDA to Surgeons: Check for Micro Clip Sterility

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FDA says hospital staff need to be aware that some devices in a manufacturers line may be sterile while other products are not.

Info Supplement GMPs Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on cGMPs for dietary supplements to the Office of Manageme...

Stakeholders Want FDA Approval of All Patient Info

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Dismissing an FDA proposal to limit its review and approval of patient medication information, stakeholders urge the agency during...

Guided Therapeutics Files PMA for Cervical Scanner

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Guided Therapeutics, Inc. files a PMA with FDA for the LightTouch Cervical Scanner for patients at risk for cervical cancer.

Regulatory Science Projects Getting $9.4 Million

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FDA and NIH are funding four regulatory science research projects over the next three years.

Info on Device Approval Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on premarket approval of devices to the Office of Manage...

FDA Approves Folate-containing OC by Bayer

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FDA approves a Bayer HealthCare combination oral contraceptive containing a folate to counter neural tube defects in developing fe...

House Passes Clinical Trials Bill

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The House approves legislation removing a financial barrier to participating in clinical trials.The House approves legislation rem...

Novartis Sues Over Famvir ANDA Approval

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Novartis sues to block FDAs approval of Watsons ANDA for generic Famvir in a split-certification case.