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FDA Approves Alere Determine HIV Test

[ Price : $8.95]

FDA approves an Alere PMA for its Alere Determine HIV-1/2 Ag/Ab Combo test, a rapid point-of-care test that detects both HIV-1/2 a...

Report Describes FDAs Personalized Medicine Efforts

[ Price : $8.95]

FDA issues a report on its work to advance personalized medicine.

No FDA Authority for Masked Safety, Efficacy Data: AdvaMed

[ Price : $8.95]

AdvaMed sharply criticizes a FDA proposal to make available masked and/or de-identified medical device sponsor data, saying the ag...

FDA Clears Reverse Medical Microcatheters

[ Price : $8.95]

FDA clears a Reverse Medical 510(k) for its ReVerse Microcatheter product line for intracranial neurovascular use.

Expedited Review May Lead to Safety Risks: Study

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Researchers Thomas Moore and Curt Furberg say FDAs greater use of expedited review may be putting some patients at risk.

Charleston Labs Stops Pain Drug Trial

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Charleston Laboratories stops a Phase 3 trial involving its anti-nausea pain drug CL-108 based on a recommendation from an indepen...

PLAIR is Tool for Bringing Overseas Products Into Pipeline: Attorney

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Attorney Peter Reichertz says manufacturers may be able to use FDAs PLAIR guidance to speed entry of approved products manufacture...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites King Systems Corp. for medical device QSR deviations.

Coalition Advances More Ways to Foster Combination Products

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The Combination Products Coalition gives FDA additional recommendations on ways to speed guidance to encourage development of inno...

CDRH Guidance on Third-party Inspection Pilot

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FDA posts a guidance to support a CDRH-backed medical device single audit pilot program that will begin in January.