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FDA reviewer guidance spells out "major and minor" PMA (premarket approval) faults

This article was originally published in Clinica

Executive Summary

The FDA has updated the guidance it uses to help staff decide whether a premarket approval application should be accepted for review. When PMAs are submitted to the agency, they are not automatically filed with the agency and assigned to a reviewer. The agency must first determine whether the application is ready for review, a process that can take up to 30 days.

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