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Court Denies Ranbaxy Generic Competition Block Bid

[ Price : $8.95]

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

FDA Approves Purdues Hysingla

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Grants Fast Track for Novavax for RSV F-Protein Vaccine

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FDA grants Novavax fast track status for its RSV F-Protein nanoparticle vaccine candidate.

Groups Back FDA Drug Compounding Enforcement

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Six stakeholder groups praise FDAs risk-based approach to regulating drug compounding.

FDA Collection of Info on Risk/Benefit Perception to OMB

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Federal Register Notice: FDA submits a proposed collection of information on risk and benefit perception scale development to the ...

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...