Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

On November 2, 2022, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will help incentivize drug manufacturers to adopt more mature quality management practices at their facilities. The committee will consider the impact that a QMM program would have on the pharmaceutical industry, drug shortages, and supply chain resiliency. FDA will seek input to determine if experts from academia and industry support the development of a CDER QMM program to incentivize investments in mature quality management practices.

On November 3, 2022, as part of CDER’s continued effort to provide key updates on modernization of quality assessment, the committee will discuss the next stages of Knowledge-Aided Assessment and Structured Application (KASA). The concept of KASA was envisioned in 2016 and discussed at the Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting on September 20, 2018, as an IT system that modernizes FDA’s assessment. Through the development, testing, and implementation of various KASA prototypes, the KASA system has been refined over the course of multiple years. FDA will seek input on the vision and plan to expand KASA over the next 5 years to include drug substances, all generic dosage forms, new drug and biologics applications, and post-approval changes. Moreover, FDA will seek input regarding the need for advancing digitalization in KASA, including data standardization and mobilization of data from cloud-based servers.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2022-N-1777.

Please visit the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement page for more information.