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.
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by…
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
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.