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Sombra Cosmetics CGMP Violations

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FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.

FDA OKs Mesoblasts Ryoncil Cell Therapy

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FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.

Clinical Investigation Protocol Deviations

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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.

Updated POLARx Instructions is Class 1 Recall: FDA

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FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.

CGMP Violations in Akorn Formulations Review

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FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...

Multiple Violations in BD Inspection

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FDA warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management S...

Brands International Limits, Delays Inspection: FDA

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FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.

FDA Promotes Centralized Statistical Trial Monitoring

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FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.

DTC Ad Enforcement to Increase Under Trump: Panel

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Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration is likely to target and seek ...

FDA Sees New Ocaliva Liver Injuries

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FDA says it has identified serious liver injuries in patients without cirrhosis of the liver being treated for primary biliary cho...