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3rd Circuit Upholds Medicaid Fee Ruling

[ Price : $8.95]

The 3rd Circuit Appeals Court upholds a lower court ruling dismissing a whistleblower suit brought by the federal government and s...

FDA Issues Allergan Complete Response on Fibroid Drug

[ Price : $8.95]

FDA issues Allergan a complete response letter on its NDA for ulipristal acetate, indicated for treating abnormal uterine bleeding...

Meeting on Drug Quality Standardized Data

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Federal Register notice: FDA announces a 10/19 public meeting entitled Standardized Data for Pharmaceutical Quality/Chemistry Manu...

Ditropan XL Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Ditropan XL (oxybutynin chloride) extended release tablets 15mg were not withdrawn fr...

Faster Transcranial Magnetic Stimulation Treatment Cleared

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FDA clears a MagVenture 510(k) for a faster treatment protocol for its Transcranial Magnetic Stimulation and its use in treating d...

FDA Approves 1st Neurotrophic Keratitis Drug

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FDA approves Dompe Farmaceuticis Oxervate to treat neurotrophic keratitis, the first for this disease.

Mallinckrodt Stannsoporfin Complete Response Letter

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FDA issues a complete response letter with recommendations for resubmitting Malinckrodys NDA for stannsoporfin.

Public Meeting on Opioid Use Disorder Treatments

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Federal Register notice: FDA announces a 9/20 public meeting entitled Expanding Access to Effective Treatment for Opioid Use Disor...

Gynesonics Sonata Fibroid Ablation System Cleared

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FDA clears a Gynesonics 510(k) to market its Sonata Sonography-Guided Transcervical Fibroid Ablation System.

Hangzhou Karic Inspection Violations

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FDA warns Chinas Hangzhou Karic Commodities about CGMP violations in its production of finished pharmaceuticals.