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FDA Advancing Biomarker Science in Drug Development

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FDA identifies several opportunities to advance biomarker science for product development.

Dallas Judge Cuts Transvaginal Mesh Award in Half

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A Dallas, TX judge slashes a jury award of $73 million to a woman who said she was injured by a Boston Scientific Corp transvagina...

Guidance on Laboratory Developed Test Notification and Reporting

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Federal Register Notice: FDA releases a draft guidance: FDA Notification and Medical Device Reporting for Laboratory Developed Tes...

Durata Therapeutics Gets Special Protocol Agreement in Pneumonia Trial

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FDA grants Durata Therapeutics a Special Protocol Agreement on the design of the companys Phase 3 study of Dalvance IV 1500 mg in ...

FDA Opens New Compliance Dashboard

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FDA Office of Enforcement and Import Operations director Douglas Stearn describes a new online dashboard with compliance, inspecti...

Consultants Debunk 3 FAERS Myths

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AdverseEvents says its research debunks three widely-held myths about the value of the FDA Adverse Events Reporting System.

FDA Tech Transfer Unit Helps Agency Inventions to Market

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FDA technology transfer head says that each year agency researchers produce about 20 patentable inventions.

FDA Grants Ariad Breakthough Status for Lung Cancer Therapy

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FDA grants Ariad Pharmaceuticals a breakthrough therapy designation for APs6113 and its use in treating patients with anaplastic l...

Viagra TV Spot Targets Women

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Pfizer breaks a new DTC ad strategy for Viagra, using a women to speak directly to men about erectile dysfunction and its effect o...

Animal Antimicrobial Use Up in 2009-12

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The Center for Veterinary Medicine says that the total quantity of medically important antimicrobials sold or distributed for use ...