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Military Deployments Delay FDA Studies on LASIK

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U.S. military deployments lead to a prolonged delay in an FDA quality-of-life study in LASIK patients being conducted by the Depar...

FDA Develops Hemagglutinin Antigen Measurement

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FDA scientists describe a newly-developed technique for measuring the amount of hemagglutinin antigen in flu vaccines.

Latest FDA Warning Letters

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In its latest batch Henry A. Frazer, Jabones Pardo, John Brasil Dairy, Stewart Pharmaceuticals, and Sundial Herbal Products.

FDA Approves New Warner Chilcott Contraceptive

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FDA approves a Warner Chilcotts Lo Minastrin FE (norethindrone acetate and ethinyl estradiol chewable tablets, ethinyl estradiol t...

Fresenius Warns Against Mobile Device Reg Overlap

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Fresenius Medical asks FDA and other agencies to ensure that there is no regulatory overlap or unintended consequences in regulati...

FDA Transcript Posted on Analgesic Workshop

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FDA posts the transcript from a 5/30-31 workshop on Assessment of Analgesic Treatment of Chronic Pain.

Hospira Recalls 1 Lot of Aminosyn II

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Hospira recalls one lot of Aminosyn II 10%, sulfite-free 500mL, due to foreign particles (human hair) detected in the injection po...

Janssen Files BLA and European Submission for Siltuximab

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Janssen Research & Development submits a BLA and a European marketing application for siltuximab, indicated for treating patients ...

Petition Asks MRI Performance Standards

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Thomas Quinn petitions FDA to amend its regulations to specify performance standards for nuclear MRIs.

Allergan Wants New Guidance on Restasis Bioequivalence

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Allergan asks FDA for a new guidance on determining bioequivalence for a generic form of its Restasis.