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FDA Clears Alphatecs Pedicle Screw

[ Price : $8.95]

FDA clears an Alphatec Holdings 510(k) for the Zodiac Luxe 4mm diameter pedicle screw for use with all Zodiac spinal disorder solu...

Info on Animal Drug User Fees Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on animal drug user fees and fee waivers and reductions to...

Move to DTC Infomercials: Zifkin

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Zephyr Media Group president Dan Zifkin says drug companies should consider abandoning one-minute TV spots for 30-minute infomerci...

Woodcock Praises Reagan-Udall Foundation

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FDA chief medical officer Janet Woodcock, says the controversial Reagan-Udall Foundation may provide important support for applied...

FDA OKs Nexavar for Liver Cancer

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FDA approves a Bayer HealthCare and Onyx Pharmaceuticals NDA for Nexavar (sorafenib) tablets, indicated for treating patients with...

FDA Wants Another Trial for Huntingtons Drug

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FDA asks Amarin Corp. to conduct an additional Phase 3 clinical trial to provide confirmatory evidence on its investigational drug...

FDA Vows Follow-up to Risky Devices Expos

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CDRH compliance director Tim Ulatowski says FDA is investigating reports of flagrant marketing of illegal and dangerous medical de...

Update on Antibiotics in Aquarium Fish

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Consulting editor John Scharmann updates information on the status of human-use antibiotics in home aquariums.

RLS Foundation Takes on Consumer Reports

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The Restless Leg Syndrome Foundation calls on its members and supporters to cancel subscriptions to Consumer Reports after the mag...

Learned Intermediary Rule Out in WV

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American Enterprise Institute fellow Ted Frank says there are many reasons why the West Virginia Supreme Court erred in throwing o...