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House Committee Initiative Mulls Off-label Dissemination Changes

[ Price : $8.95]

House Energy and Commerce Committee 21st Century Cures initiative leaders show interest in how companies communicate off-label inf...

FDA Accepts NDA for Actavis IBS Drug

[ Price : $8.95]

FDA accepts an Actavis NDA for eluxadoline, indicated for treating diarrhea and abdominal pain in men and women with diarrhea pred...

Illinois Compounding Pharmacy Recalls Sterile Preparations

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FDA says Martin Avenue Pharmacy is recalling all compounded sterile preparations due to a risk to sterility assurance.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Blanc du Blanc, Carousel Solutions, I''m a Little Teacup, Iradimed Corp., Marel ...

Info on Drug Compounding Facilities Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information contained in guidance on fees for human drug compounding...

Jadelle Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Population Council/Scherings Jadelle (levonorgestrel) implant was not withdrawn for r...

Guidance on Biologic E-Submission of Lot Distribution Reports

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Federal Register Notice: FDA releases a draft guidance on electronic submission of lot distribution reports for applicants with ap...

FDA Clears Nonin Medical Finger Pulse Oximeter

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FDA clears Nonin Medicals Nonin Model 3231 OEM/eHealth finger pulse oximeter to measure oxygen saturation and pulse rate.

FDA Clears Vital Connect HealthPatch MD Home Monitor

[ Price : $8.95]

FDA clears a Vital Connect 510(k) for its HealthPatch MD biosensor for monitoring patients at home.

Court Nixes Request to Reverse $9 Billion Actos Damage Award

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A Western District of Louisiana federal judge rejects a Takeda Pharmaceutical and Eli Lilly request to reverse a $9 billion puniti...