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FDA OKs St. Judes Epic Tissue Valve

[ Price : $8.95]

FDA approves St. Jude Medicals Epic Stented Tissue Valve with Linx AC Technology for use in heart valve replacement surgeries.

Ashcroft Role in Device Deal Has Higher Possibilities

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Consulting editor John Scharmann reviews the higher political implications of a deal which gives former attorney general John Ashc...

FDA Accepts Schering NDA on Asenapine

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FDA accepts for review a Schering-Plough NDA for asenapine, a sublingual tablet indicated for treating schizophrenia and acute man...

Two Drug Shortages Resolved

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FDA says drug shortages involving Pfizer/Hospiras Solu-Cortef and Akrons Indocyanine Green have been resolved.

Legislation on Disclosing Physician Gifts

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Rep. Peter DeFazio plans legislation to require drug companies to publicly list all gifts to doctors of $25 or more.

CBER Inspecting IND/IDE Studies More

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CBER Bioresearch Monitoring Branch chief Patricia Holobaugh says the branch is expanding its investigations of clinical studies.

FDA Removes Clinical Hold on Gene Therapy

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FDA removes a clinical hold on a Targeted Genetics gene therapy trial that was under scrutiny after a patient died following thera...

Labopharm Continues Tramadol Dispute

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Labopharm says it will appeal to the next CDER supervisory level a decision not to overturn a 5/07 approvable letter for the compa...

FDA Wants New Warning on Tamiflu, Relenza

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FDA safety reviewers recommend a new precautionary wording be added to the labeling of Roches Tamiflu and GlaxoSmithKlines Relenza...

Tykerb Launch Promos Misleading: DDMAC

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CDER warns GlaxoSmithKline over violative promotional letters sent to healthcare professionals during the launch of Tykerb.