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Novartis Slowing on Quality Issue Remediation at FDA-troubled Plant

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Novartis says remediating FDA-cited quality issues at the companys Lincoln, NE manufacturing facility is taking longer than expect...

FDA Clears Osseon Bone Tamp

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FDA clears an Osseon Therapeutics 510(k) for its Osseoflex SB steerable inflatable bone tamp for use in treating vertebral compres...

Hydrocodone Combination Abuse Potential Difficult: FDA

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FDA medical reviewers say it is difficult to give a definitive quantitative analysis of the abuse potential for hydrocodone combin...

FY 2013 Rates Set for Generic Drug Fees

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Federal Register Notice: FDA announces the rates for ANDA, Prior Approval Supplement, and Drug Master File fees for fiscal year 20...

Senators Ask FDA to Document Involvement with NECC

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The Senate HELP Committee requests large numbers of documents from FDA, New England Compounding Center, and the Massachusetts Phar...

R&D Decline, Sequestration Menace Innovation: Report

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A Research!America 2011 U.S. Investment in Health Research report finds a decline in biomedical and health research and developmen...

Help Low-income Countries with Regulation: FDA

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Three FDA staffers in the Office of International Programs say there is a need to help medical product regulatory systems in low- ...

FDA Safety Alert on OTC Eye/Nasal Drops

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FDA warns the public about children accidentally ingesting over-the-counter eye drops and nasal decongestant sprays.

Bayer and Qiagen Partner in Cancer Companion Diagnostics

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Bayer and Qiagen say they are collaborating on efforts to pair Qiagen companion diagnostics with Bayer personalized therapies for ...

Judge Puts Hold on Pay-for-delay Case

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A New Jersey federal judge stays proceedings in a pay-for-delay case involving Wyeths Effexor XR and Teva until the Supreme Court ...