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Man Indicted for Illegal Animal Drug

[ Price : $8.95]

A Puerto Rico federal grand jury indicts an individual on charges relating to shipments of an illegal, adulterated, and misbranded...

FDA Initial Steps on CBD Explained

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Mintz attorney Joanna Hawana explains FDAs position of regulating cannabis-derived products as shown in recent public announcement...

FDA Denies US WorldMeds Apokyn Petition

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Citing time restrictions, FDA denies without comment a US WorldMeds petition asking for specific treatment of any ANDA citing its ...

FDA Orders Fertility Clinic to Cease Manufacturing

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FDA orders a fertility clinic in San Juan, Puerto Rico, to cease manufacturing due to significant violations of agency regulations...

Evofem Biosciences Re-files NDA for Amphora

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Evofem Biosciences resubmits its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH ...

Nurse Sentenced for Insys Fentanyl Kickbacks

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The Justice Department says an advance practice nurse who worked in a pain clinic was sentenced to three years of probation for ac...

CGMP Violations at Lohxa LLC

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FDA warns Lohxa LLC about CGMP violations in its production of finished pharmaceuticals.

Device-Related Infections Likely Antibiotic-Resistant: Study

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A Center for Disease Control and Prevention report says that healthcare-associated infections resulting from medical devices are m...

CymaBay Stops Seladelpar Studies Over Safety Concerns

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CymaBay Therapeutics terminates a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently ini...

Device Sterilization Master File Pilot

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Federal Register notice: CDRH announces an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization pr...