Quality Metrics for Pharmaceuticals: FDA Unveils Two New Voluntary Programs
The US Food and Drug Administration (FDA) on Thursday revealed two new programs to gather feedback on the use of quality metrics and to provide ways for industry to engage the agency and inform FDA’s use of quality metrics.One program, known as the Quality Metrics Feedback Program, is meant to encourage new drug application holders to request Type C Formal Meetings and abbreviated new drug application (ANDA) holders to submit pre-ANDA meeting requests to discuss quality metrics.
FDA also said it will launch a pilot study to gain feedback from other types of establishments, including active pharmaceutical ingredients (API) establishments, contract manufacturing organizations (CMOs), over-the-counter (OTC) monograph product establishments or marketed unapproved finished drug product establishments.
The other program, known as the Quality Metrics Site Visit Program, is designed to offer experience with FDA staff ito develop FDA's quality metrics program, the agency said. FDA staff will also observe how metrics data are gathered, collected and reported to management.
“Feedback from early adopters, manufacturers who implemented quality metrics programs to address significant manufacturing problems, and independent academic research indicates that manufacturers’ overall quality programs benefit from an establishment’s quality metrics program,” FDA said in a statement.
“Participation in either of these efforts is voluntary, and the programs are intended to foster the joint efforts of FDA and stakeholders to further understand robust quality metrics programs, which will help FDA, drug manufacturers, and patients.
FDA also said it intends to use quality metrics data to further develop its risk-based inspection scheduling (“e.g., decreased surveillance inspection frequency for certain establishments”).
The biopharma industry previously took issue with FDA’s approach on quality metrics guidance.
Quality metrics
Quality Metrics Feedback Program
Quality Metrics Site Visit Program
Federal Register