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Senators Want Medical Device Tax Delayed

[ Price : $8.95]

AdvaMed praises a call by 18 senators for a delay in implementation of the upcoming medical device tax.

FDA Denies Merck Nasonex Petition

[ Price : $8.95]

FDA denies a Merck petition asking that it not accept ANDAs for generic Nasonex.

FDA 6-month Pediatric Exclusivity for Aciphex

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FDA awards Eisai an additional six months marketing exclusivity for Aciphex for meeting criteria under the agencys pediatric exclu...

MDR, QS Violations Found at MedArt

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FDA warns MedArt about Medical Device Reporting and Quality System violations found in an inspection at a company manufacturing fa...

Consumers See Disease Risk in Cheaper Life-saving Drugs

[ Price : $8.95]

A Journal of Consumer Research study finds that drug prices affect how much risk consumers think they have of contracting the dise...

FDA Clears Lensar Laser for Corneal Incisions

[ Price : $8.95]

FDA clears a Lensar 510(k) for its laser system for use in executing corneal incisions during cataract surgery.

CDER First-Cycle Approvals Highest in 20 Years: Jenkins

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CDER Office of New Drugs director John Jenkins says the first-cycle approval rate in 2012 is at the highest level in 20 years.

Exact Sciences PMA Module for Colorectal Cancer Screener

[ Price : $8.95]

Exact Sciences Corp. files the first PMA module for its stool DNA colorectal cancer screening test.

Panel to Discuss Janssens NDA for Type 2 Diabetes

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 1/10/13 to discuss Janssens NDA for ...

Cellular, Tissue and Gene Therapies Panel to Meet

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Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 1/15/13 to discuss intramural resea...