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Merck Wins Court Decision to Block Teva's Generic Temodar

[ Price : $8.95]

Merck wins a federal appellate court decision blocking a Teva ANDA for a generic copy of its brain tumor drug Temodar (temozolomid...

Vitek Cards Recalled

[ Price : $8.95]

FDA says bioMrieux is recalling specific Vitek 2 negative susceptibility cards that are reporting incorrect results.

Amphetamine Sulfate Not Withdrawn for S&E

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Federal Register Notice: FDA determines that amphetamine sulfate 5 and 10 mg tablets was not withdrawn for reasons of safety or ef...

Special Control Guidance Available for Tissue Adhesive

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Federal Register Notice: FDA releases a special controls guidance on tissue adhesive with adjunct wound closure device intended fo...

FDA, Industry Scrap 'Info Sharing' in PDUFA Reauthorization

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FDA and drug industry representatives agree to remove a proposed information sharing phase as part of an alternative review model ...

GAO Report Critical of FDA Heparin Probe

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A new GAO report finds that FDA did not sanction some Chinese firms that refused to allow agency investigators access to perform a...

FDA 'Fast Track' Status for Sanofi Vaccine

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FDA grants Sanofi Pasteur a fast track designation for its investigational clostridium difficile vaccine candidate.

Hamburg Urges Caution in FDA Cuts

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FDA commissioner Margaret Hamburg says Republican House members should think carefully about the impact before cutting FDA funding...

FDA Suggests Androxal Phase 2B Study Before Phase 3

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FDA suggests that Repros Therapeutics conduct a Phase 2B Androxal trial before moving to Phase 3 studies.

FDA Probing CT Scan Radiation Reports

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FDA says it has developed recommendations that should reduces instances of excess doses of radiation to some patients undergoing C...