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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 ...

FDA Clears Esaote Laptop-Sized Ultrasound

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FDA clears Esaote North Americas MyLab Gamma portable laptop-sized ultrasound system.

Guidance on Cybersecurity in Devices

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Federal Register Notice: FDA releases a guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devi...

FDA OKs B. Braun Bulk Sterile Water for Compounding

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FDA approves B. Braun Medicals Sterile Water for Injection USP in 2L and 3L containers for compounding devices.

EMA Runs Past FDA on Clinical Trial Transparency Front

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The European Medicines Agency moves ahead of FDA in terms of clinical trial data transparency with its 10/2 decision to publish th...