BIO Submits Comments on Quality Management Maturity (QMM) Program and Knowledge-Aided Assessment and Structured Application (KASA)
November 1, 2022
On November 1st, BIO submitted comments in response to the Food & Drug Administration’s (FDA) recent Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. The meeting was primarily focused on two topics: the future of the Quality Management Maturity (QMM) program and the next stages of Knowledge-Aided Assessment and Structured Application (KASA). In particular, FDA requested feedback from stakeholders on the development of a CDER QMM program to incentivize investments in mature quality management practices. On this topic, BIO provided three primary recommendations: (1) A QMM program should be voluntary and industry-driven if implemented; (2) Any QMM assessment model should be standardized and well-integrated with related programs; and (3) Details about the proposed implementation of a QMM program should be clarified. During the Advisory Committee meeting, FDA also requested feedback on its vision and plan to expand KASA over the next five years to include drug substances, all generic dosage forms, new drug and biologics applications, and post-approval changes. Regarding KASA, BIO stressed the importance of utilizing the system to build upon international harmonization efforts and to support interoperability of data standards, in contrast to its potential for introducing further integration challenges and regulatory discrepancies. BIO also suggested that a pilot program conducted in partnership with industry would provide valuable insight on the potential benefits, challenges, gaps, and best practices associated with the implementation of KASA.
Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
On November 1st, BIO submitted comments in response to the Food & Drug Administration’s (FDA) recent Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. The meeting was primarily focused on two topics: the future of the Quality Management Maturity (QMM) program and the next stages of Knowledge-Aided Assessment and Structured Application (KASA). In particular, FDA requested feedback from stakeholders on the development of a CDER QMM program to incentivize investments in mature quality management practices. On this topic, BIO provided three primary recommendations: (1) A QMM program should be voluntary and industry-driven if implemented; (2) Any QMM assessment model should be standardized and well-integrated with related programs; and (3) Details about the proposed implementation of a QMM program should be clarified. During the Advisory Committee meeting, FDA also requested feedback on its vision and plan to expand KASA over the next five years to include drug substances, all generic dosage forms, new drug and biologics applications, and post-approval changes. Regarding KASA, BIO stressed the importance of utilizing the system to build upon international harmonization efforts and to support interoperability of data standards, in contrast to its potential for introducing further integration challenges and regulatory discrepancies. BIO also suggested that a pilot program conducted in partnership with industry would provide valuable insight on the potential benefits, challenges, gaps, and best practices associated with the implementation of KASA.