FDA Extends Comment Period For Its “Request for Quality Metrics” Draft Guidance
August 28, 2015
Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics. The guidance states that the data will be used for various activities, including: to predict potential drug shortages, improve the evaluation of drug manufacturing and control operations, improve the Agency’s efficiency and effectiveness of establishment inspections, and develop a schedule for risk-based inspections.
On Monday, August 27, 2015, FDA held a public meeting in which they discussed this draft guidance with drug makers and other industry personnel. This was the first opportunity for any open discussion between the industry and FDA, and as would be expected, there were many questions and a plethora of discussions that occurred. While the Agency was able to provide some clarification on some of the questions that were posed, it also announced that the final guidance would not be released until 2016. In addition, FDA has decided to extend the comment period for an additional 60 days, allowing feedback to be submitted until November 27, 2015.
Best Practices for Meeting-Related Communication with FDA
In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft...