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FDA Clears Canon Tonometer

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FDA clears a Canon USA 510(k) for the TX-20 Full Auto Tonometer for detecting glaucoma.

Senate Rejects Amendment on Personal Drug Importation

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The Senate rejects an amendment that would have permitted Americans to personally import lower-priced prescription drugs from Cana...

FDA OKs Ivy Labs sANADA for Heifers

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Federal Register Final rule: FDA approves an Ivy Labs supplemental ANADA for using increased levels of monensin in medicated heife...

ICH Guidance on E-submission of Individual Case Safety Reports

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Federal Register Notice: FDA releases a draft guidance and appendix, E2B(R3) Electronic Transmission of Individual Case Safety Rep...

FDA Approves Expanded Use for Byetta

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FDA approves an expanded use for Amylin Pharmaceuticals and Eli Lillys Byetta (exenatide) for injection as an add-on therapy to in...

Drug Safety Oversight Board Looks at Drug Naming

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FDAs Drug Safety Oversight Board considers a USP drug naming monograph, prescription sleep aid driving risks, and the opioid REMS ...

Hamburg Announces 4 FDA Presidential Rank Awards

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FDA commissioner Margaret Hamburg announces that four senior FDAers won FY 2011 Presidential Rank Awards.

Class 1 Recall of CareFusion Ventilators

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FDA classifies as Class 1 a CareFusion recall of 128 EnVe ventilators affecting 29 customers.

Info on Safe Online Drug Purchases Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on educating consumers to safety purchase drugs online.

Info on Substances Prohibited in Animal Feed Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on substances prohibited in animal food or feed to the O...