FDA Gives Drugmakers More Time to Join Quality Metrics Feedback Program
The US Food and Drug Administration (FDA) on Friday reopened the submission period for its Quality Metrics Feedback Program for another 120 days after the one-year submission window closed in June.The feedback program is one of two voluntary quality metrics pilot programs FDA announced in June 2018 and is intended to encourage new drug application (NDA) holders to request Type C Formal Meetings and abbreviated new drug application (ANDA) to submit pre-ANDA meeting requests to discuss quality metrics with the agency.
The other program, the Quality Metrics Site Visit Program, is aimed at giving FDA staff the opportunity to visit with drugmakers to “observe how quality metrics data are gathered, collected, and reported to management.” FDA also extended the submission period for the site visit program by 120 days before the original 60-day proposal window closed in August 2018.
Now, companies have until 30 December 2019 to express interest in participating in the Quality Metrics Feedback Program.
FDA says it has received questions from companies about what topics could be covered during the feedback meetings as part of the program.
FDA encourages companies to include any relevant topic that could help stakeholders understand the agency’s quality metrics approach in submissions for the program, and notes that companies may “include or exclude topics in their meeting request or submissions to the pilot program.”
Since first detailing its plans to use quality metrics to improve its ability to conduct risk-based inspections and predict or mitigate possible drug shortages in 2015, FDA has faced resistance from industry. That pushback led the agency to revise its draft quality metrics guidance in 2016, making the program voluntary until they agency can initiate notice and comment rulemaking to make the program mandatory.
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