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Ortho Biotech Dropping Sporanox Injection

[ Price : $8.95]

Ortho Biotech says it is discontinuing Sporanox for injection and expects its warehouse to have distributed all remaining supplies...

FDA Asks Kytril Exclusivity Comment

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Teva says it should be entitled to 180 days market exclusivity for generic Kytril despite expiration of the 30-month period in th...

Troubled Chinese Firm Makes RU-486, Group Says

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Newly released FDA documents on the abortion drug RU-486 disclose officially for the first time that a Chinese pharmaceutical manu...

Academic-Industry Relationships Can Cause Problems

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Researchers writing in the Journal of the American Medical Association say relationships between industry and medical schools are ...

CDER Seeks Firms for Site Tour Program

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Federal Register Notice: CDER plans to continue the Regulatory Project Management Site Tours and Regulatory Interaction Program an...

FDA Clears Blood Clot Risk Test

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FDA clears a Nanosphere, Inc. 510(k) for the Verigene F5 / F2 / MTHFR Nucleic Acid Test for detecting disease-associated gene muta...

Resource Lack Still Hampers FDA in China: Dingell, Barton

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Bipartisan congressional overseers find FDAs foreign drug inspections in China and India are still hampered by resource limitation...

Masoudi Rejoins FDA as Chief Counsel

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Former FDA deputy chief counsel Gerald F. Masoudi rejoins FDA as its new chief counsel.

Safety Alert Issued on Amylins Byetta

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FDA issues a safety alert on Amylin Pharmaceuticals Type 2 diabetes drug Byetta after reviewing 30 postmarketing reports of acute ...

FDA Covered Up Medtronic Problems: Public Citizen

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Sidney Wolfe asks why FDA didnt order a recall of Medtronic Sprint Fidelis defibrillators much earlier this year when reports of a...