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Multiple Avertix Medical Violations Cited

[ Price : $8.95]

FDA warns Eatontown, NJ-based Avertix Medical about Quality System, Medical Device Reporting, and Correction and Removal violation...

Indias Patcos Markets Insanitary OTC Drugs with CGMP Issues: FDA

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FDA warns Indias Patcos Cosmetics that it is marketing adulterated over-the-counter drug products that have significant violations...

Guide Aims to Expand Non-Animal Methods in Drug Development

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FDA issues a draft guidance encouraging drug developers to adopt new approach methodologies as part of a broader effort to reduce ...

Some Agreements in MDUFA 6 Negotiations

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Minutes from two February MDUFA 6 negotiating sessions show areas of agreement between FDA and industry and topics for which furth...

FDA Approves J&Js Icotyde for Plaque Psoriasis

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FDA approves Johnson & Johnsons Icotyde as the first and only targeted oral peptide to treat plaque psoriasis in adults and some p...

Experts Urge 32 FDA Transparency Reforms in New JAMA Viewpoint

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Public health experts call for sweeping reforms to improve FDAs transparency, arguing that longstanding gaps in disclosure persist...

FDA Updates Guidance on Pyrogen and Endotoxin Testing

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FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and med...

FDA Warns of Potentially High-Risk Issue With Insulet Insulin Pumps

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FDA issues an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet.

Oralabs Cited for CGMP Violations

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FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.

API Deviations Seen in Flowchem Pharma Inspection

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FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.