As FDA committed at the November 2022 meeting of the Pharmaceutical Science Advisory Committee, the agency is continuing to seek public feedback on CDER’s development of a Quality Management Maturity program to promote mature quality management practices at drug manufacturing establishments. FDA has developed a list of questions for input and welcomes other pertinent information the public would like to share on this topic. CDER recently published a white paper titled “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development,” that describes planned elements of the assessment protocol; FDA welcomes public feedback on other aspects of the planned program. Submit comments to the docket by Dec. 14, 2023 ...[FDA]