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Knowledge aided Assessment and Structured Application (KASA) Initiative

The current challenges with the eCTD system that the agency currently uses, explaining how it does “not follow the development flow of the drug product,” and “contains unstructured data in text-based PDF files” that can lead to “redundancy and lengthy assessments.”

KASA is a system that captures and manages information about inherent risk and control approaches for product design, manufacturing, and facilities, in a structured format. This is intended to facilitate a concise and consistent quality assessment and largely replace freestyle text.

The KASA interface tabulates the following for each critical product quality attribute:

1) Inherent risk to quality.

2) Control approaches – using a list of generalized structured descriptors related to pharmaceutical design, development, control strategy, and facility implementation.

3) A concise summary from the assessor detailing how the generalized approaches are applied in the regulatory application.

4) Links to supporting information from the application.

The review program has already launched for abbreviated new drug applications (ANDAs) for solid oral dosage forms and will eventually be rolled out for new drug applications (NDAs) and ANDA liquid dosage forms in FY 2023.

KASA will be phased in for investigational new drug applications (INDs) and post-approval changes in FY 2024, with work on biologics license applications (BLAs) modules continuing in FY 2025.

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