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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...

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...

Drug Sponsors Shun Biosimilars Pathway: FDA

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CDER associate director for biosimilars Leah Christl says biosimilar product developers have essentially ignored FDAs abbreviated ...

Roxane Wants Jazz Xyrem Petition Denied

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Roxane tells FDA it should deny Jazz Pharmaceuticals latest citizen petition seeking to delay review of any ANDAs for generic Xyre...

Senators Want Medical Device Tax Delayed

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AdvaMed praises a call by 18 senators for a delay in implementation of the upcoming medical device tax.

FDA Denies Merck Nasonex Petition

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FDA denies a Merck petition asking that it not accept ANDAs for generic Nasonex.

FDA 6-month Pediatric Exclusivity for Aciphex

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FDA awards Eisai an additional six months marketing exclusivity for Aciphex for meeting criteria under the agencys pediatric exclu...