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FDA’s KASA Review Methods Expanding Scope to Include Drug Substances

FDA’s KASA Review Methods Expanding Scope to Include Drug Substances

The US Food and Drug Administration’s (FDA) Knowledge-aided Assessment and Structured Application (KASA) review method is endeavoring to expand into drug substances. This is intended to support and address quality system related challenges that are related to New Drug Applications (NDA) submitted to the FDA.

FDA’s KASA is a system that was launched in 2019 as a part of the agency’s efforts to modernize its current quality systems.

What is KASA?

KASA has built-in rules and algorithms that help to estimate the initial inherent product and manufacturing risks of a new therapy being submitted to the FDA for approval. This also supports risk controls that are related to product design and manufacturing.

Although KASA is primarily being developed as an assessment tool, it is capable of far more and has the potential to alleviate problems associated with electronic regulatory drug applications.

2024 expansion on the horizon

The FDA’s KASA review method has already been launched for abbreviated new drug applications (ANDAs) for solid oral dosage forms. Now, they are expected to expand into new drug applications (NDAs) in 2024.

Currently, new drug applications (NDAs) received by the FDA have unstructured data fields that have the potential to make risk assessment difficult. Under the FDA’s KASA review method, the agency will use machine readable data fields that enable easy parsing of unstructured data.

This has the potential to greatly reduce the FDA’s workload.

KASA’s expansion will help meet growing medical needs quicker

The built-in algorithms allow assessors to focus on high-risk areas and issues first. This provides for improved effectiveness and efficiency of the regulatory assessment by semi-automating the FDA’s quality assessment.

Ultimately, it can facilitate the introduction of new breakthrough therapeutics and low cost, high-quality generic drugs to meet growing medical needs and concerns.

In its final form, the FDA’s KASA review method is expected to contribute to:

  • patient-focused quality and objectivity of regulatory actions through knowledge management;
  • improving science- and risk-based regulatory approaches through established rules and algorithms, and;
  • enriching regulatory oversight through product and facility lifecycle management.

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References

Authored by: Nisha Nair, Senior Medical Writer, Regulatory and Medical Writing