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Advisors Back Vimizim Approval

[ Price : $8.95]

Members of FDAs Endocrinologic and Metabolic Drugs Advisory Committee recommend approval of BioMarins Vimizim for treating Morquio...

Guidance on Transfusion/Transplant Test Kits

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Federal Register Notice; FDA releases a draft guidance on 510(k) submissions for nucleic acid-based human leukocyte antigen test k...

FDA Corrects Rule on Tobacco Rule

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Federal Register Final rule: FDA is correcting a minor error in a 2010 final rule amending certain regulations to include tobacco ...

Perrigo Files ANDA for Generic Acanya

[ Price : $8.95]

Perrigo files an ANDA for clindamycin phosphate and benzoyl peroxide gel 1.2%/2.5%, a generic copy of Dow Pharmasciences Acanya.

FDA Clears TauTona Fat Graft Injector

[ Price : $8.95]

FDA clears a TauTona Group 510(k) for the TauTona Tissue Injector, a single-use, hand-held adipose tissue transfer tool for use in...

Generic Drug Labeling Proposal Could Cause New Issues: Attorneys

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Attorneys writing online say FDAs proposed rule to allow generic drug companies to make safety labeling changes could raise new pr...

CDER Refused to File 500 ANDAs Last 4 Years

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CDER says it has refused to accept 497 ANDAs over the past four years (2009-2012) due to application deficiencies.

OPDP Finds Multiple Violations in Ribasphere Letter

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CDERs Office of Prescription Drug Promotion warns Kadmon Pharmaceuticals about multiple promotional violations in Ribasphere intro...

FDA Warns of Stress Test Agent Risk

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FDA warns of a rare risk of heart attack or death in some patients given cardiac nuclear stress test agents

FDA Clears 4 Illumina Next-Gen Sequencing Diagnostics

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FDA clears four Illumina next generation diagnostic devices that can be used for high throughput gene sequencing of a patients DNA...