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Sombra Cosmetics CGMP Violations

[ Price : $8.95]

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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.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

ICH M15 Model-Informed Drug Development Principles

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FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.

AMT Designation Program Guidance

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FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Pro...

ICH E11A Pediatric Extrapolation Guidance

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FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.

ICH Clinical Practice Guide Annex

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FDA publishes Annex 2 of the International Council on Harmonization Good Clinical Practice guidance.