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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 ...

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.

Look at Underlying Trends in Generic Drug Prices: Gottlieb

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Former FDA deputy commissioner Scott Gottlieb calls on Congress to focus on underlying policies and trends that could lead to an o...

FDA, EMA Advance Mutual Reliance on GMP Inspections

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FDA meets with European Medicines Agency and GMP experts from EU member states to advance a mutual reliance initiative for GMP ins...

FDA Approves Kubtec Portable X-ray System for Neonates

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FDA approves a Kubtec PMA for its KUB 250, a portable low-dose digital X-ray system dedicated to the neonatal intensive care unit.