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OMB OKs Info on Disease Info in Branded Promos

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on an experimental study on...

Guidance for Home Use Device Design

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FDA publishes a draft guidance to help manufacturers design and develop home use medical devices that minimize their unique risks.

Pfizer Pays $55 Million to Settle Protonix Off-label Activities

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Pfizer agrees to pay $55 million plus interest to resolve allegations that its Wyeth subsidiary illegally introduced into intersta...

Orphan Status for Diffusion Pharma Brain Cancer Therapy

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FDA grants Diffusion Pharmaceuticals an Orphan Drug designation for trans sodium crocetinate and its use in treating metastatic br...

Multiple QS Violations Found at Parks Medical Electronics

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FDAs Seattle District Office warns Parks Medical Electronics about multiple Quality System violations at its facility manufacturin...

Info on Device Pre-submission Meetings Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

FDA Debars Knott

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Federal Register Notice: FDA debars Susan F. Knott for two years from providing services to any person with an approved or pending...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites GC America, The Judge Rotenberg Educational Center, MedArt A/S, Parks Medical El...

Managing Medical Devices on IT Networks Top Challenge: Survey

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Survey results from healthcare technology management professionals say their biggest challenge is managing medical devices and sys...

Consumers See Disease Risk in Cheaper Life-saving Drugs

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A Journal of Consumer Research study finds that drug prices affect how much risk consumers think they have of contracting the dise...