Tag Archive: QT

Nov 06 2012

New Guidances from FDA for October 2012

FDA released four notable new guidances in October 2012, with a focus on guidances related to medical devices: Guidance: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R1) Guidance: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals Guidance: …

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