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FDA Panel Rejects Prostate Cancer Drugs

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Members of FDAs Oncologic Drugs Advisory Committee vote not to recommend expanding use of GlaxoSmithKlines Avodart (dutasteride) a...

Advisors to Weigh Vandetanib Toxicity

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FDA medical reviewers ask the Oncologic Drugs Advisory Committee whether a proposed indication for AstraZenecas vandetanib should ...

FDA Clears X-spine Fusion System

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FDA clears an X-spine 510(k) for the AXLE Interspinous Fusion System, intended for use in providing spinal stability for lumbar fu...

Optimer Pharma NDA for New Antibiotic

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Optimer Pharmaceuticals files an NDA for fidaxomicin, indicated for treating patients with clostridium difficile infection.

Onus is on Firms, FDA for Credible Social Media Info: Report

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A New England Journal of Medicine report says FDA and industry each should be responsible for the credibility of drug and device i...

FDA Expands Program on Medical Product Safety

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Federal Register Notice: FDA plans to expand its Conference Cooperative Agreement Program, awarded to the Brookings Institution to...

JAMA Study on OTC Labeling Finds Inconsistencies

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A new study reported online in the Journal of the American Medical Association finds high levels of variability and inconsistency ...

FDA Amends Regs to Include Tobacco

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Federal Register Direct final rule: FDA amends it s regulations to include tobacco products where appropriate.

Comment Sought on National Stockpile Regulations

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Federal Register Notice: FDA seeks comments on information collection requirements on labeling requirements for products held by t...

Comments Sought on FDA Focus Group Info

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Federal Register Notice: FDA seeks comments on FDA focus groups used to gauge public opinion on FDA-regulated products.