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AMT Designation Program Guidance

[ Price : $8.95]

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

ICH E11A Pediatric Extrapolation Guidance

[ Price : $8.95]

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

ICH Clinical Practice Guide Annex

[ Price : $8.95]

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

Brands International Limits, Delays Inspection: FDA

[ Price : $8.95]

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

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...

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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.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

Syndax Leukemia Review Extended by FDA

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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...