Zdrowie i gospodarka · 25/11/2016

FDA Releases Revised Draft Guidance for Industry on Quality Metrics Reporting Program

The Food and Drug Administration (FDA) is releasing a revised draft guidance for the pharmaceutical industry, outlining plans for a voluntary quality metrics reporting program aimed at improving compliance and inspection policies, and encouraging the use of state-of-the-art quality management systems. The program will help the FDA predict and mitigate future drug shortages, and gather insights from industry participants to inform future decision-making.