In general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA’s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA’s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. It would be helpful for FDA to more clearly state the intended use of the collected metrics and the benefits to industry. We understand that regulatory relief (e.g., less frequent inspections, post-approval manufacturing change categories) may be granted based on positive high-quality metrics; however, it is unclear whether FDA would use low-quality metrics as an indicator to increase inspections at a particular entity. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.