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Comments Extended on Quality Metrics Guidance/Meeting


Federal Register Notice: FDA is extending the comment period until 11/27 for a 7/28 and 8/7 Federal Register notice of a draft guidance entitled Request for Quality Metrics and an 8/24 corresponding public meeting. The draft guidance and public meeting are intended to gain stakeholders’ perspectives on various aspects of the development and planned implementation of a quality metrics program launched under the FD&C Act. The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the the agency’s risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA’s evaluation of drug manufacturing and control operations. To view this notice, click here.