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Federal Register Notice: FDA releases a draft guidance and appendix, E2B(R3) Electronic Transmission of Individual Case Safety Rep...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

Senators Want to Promote Antibiotic Development

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Senators Blumenthal and Corker introduce legislation to promote the development of new antibiotics to combat increasing resistance...

Dont Expand Xarelto Indication: Public Citizen

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Public Citizen says FDA should not approve an expanded indication for Bayers Xarelto in patients with atrial fibrillation.

Segasist Tech Prostate Imaging Software Cleared

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The agency clears a Segasist Technologies 510(k) for its Prostate Auto-Contouring software and its use in segmenting MRI, CT and u...

FDA to Amend Orphan Drug Regulations

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Federal Register Proposed rule: FDA proposes to amend the orphan drug regulations to clarify certain provisions and make minor imp...