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FDA, Duke Sign MOU

[ Price : $8.95]

Federal Register Notice: FDA provides a notice of a memorandum of understanding between FDA and Duke University.

RFID Compliance Guide Extended

[ Price : $8.95]

Federal Register Notice: FDA extends the expiration date for the compliance policy guide on radiofrequency identification feasibil...

Eloxatin Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Eloxatin 50 and 100 mg/vial were not withdrawn from sale for reasons of safety or eff...

FDA OKs Schering sNADA for Salmonids

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Federal Register Final rule: FDA approves a Schering-Plough Animal Health sNADA for use of florfenicol by veterinary feed to contr...

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 OKs St. Judes Epic Tissue Valve

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

Guidance on Impurities in Veterinary Products

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Federal Register Notice: FDA releases a revised ICH guidance on impurities in new veterinary medicinal products, specifically thos...

Guidance on Developing Smallpox Treatments

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Federal Register Notice: FDA releases a draft guidance on developing drugs for treating or preventing smallpox infection.

FDA OKs Elanco sNADA

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Federal Register Final rule: FDA approves an Elanco Animal Health supplemental NADA for increased monensin in cattle feed containi...

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...