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FDA Grants ChemoCentryx Orphan Status for CCX168

[ Price : $8.95]

FDA grants ChemoCentryx an orphan drug designation for CCX168 for treating atypical Hemolytic Uremic Syndrome.

Baxter Recalls Intravia Empty Containers

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Baxter Healthcare begins a Class 1 recall of its Intravia Empty Container with PVC Ports (sterile, fluid path) due to visible part...

Senate HELP Committee Approves Bill on Ebola Treatments

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The Senate Health, Education, Labor, and Pensions passes a bill designed to help speed the development of treatments and vaccines ...

CDRH Extends UDI Labeling Compliance Date

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CDRH extends until 9/24/16 the compliance date for unique identification system labeling requirements for medical devices meeting ...

Consent Decree Entered Against Dietary Supplement Maker

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FDA secures a consent decree of permanent injunction against Scilabs Nutraceuticals (Irvine, CA) to prevent the distribution of ad...

FDA Data Submission Issues Listed

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Pinnacle21 lists six of the most common data issues in FDA submissions.

Stericycle Sees Medical Device Recall Challenges

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Stericycle says its analysis of Q3 medical device recalls identifies a number of contributing factors industry needs to be aware o...

Court Denies Ranbaxy Generic Competition Block Bid

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A Minnesota federal judge denies Ranbaxys request for a restraining order to stop two generic drug companies from launching generi...

FDA Approves Purdues Hysingla

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FDA approves Purdues Hysingla ER abuse-deterrent opioid analgesic.

Alternative Approach to Drug Name Reservation Proposed

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Novartis proposes an alternate approach to enabling drug companies to reserve proprietary product names.