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There’s been some buzzing about the FDA instituting a new review system called Knowledge-aided Assessment and Structured Application (KASA). In September 2018, the FDA met with the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee to explore the positive aspects of adopting this platform.
The goal of adopting KASA is to modernize generic drug reviews which are currently text-based into a data-based assessment. There have also been some discussions that KASA could also be applied to new drug applications as well as biologics license applications.
Some of the benefits of using a KASA system would capture and manage information about a drug product including:
• Identifying risks; mitigation and communication, and control strategy during product lifecycle,
• Using computer-aided analyses to compare regulatory standards and evaluate quality risks against approved applications and facilities;
• Improve the objectivity of regulatory actions, as well as to provide more consistency and better communication,
• Enable assessors to automatically retrieve historical data and facility information which equates to better evaluations and decisions,
• Reduce the subjectivity of documentation and time liabilities, and
• Improve the quality and efficiency of assessments.
The FDA also noted that the eCTD system currently used by the agency does not follow the development flow of the drug product and contains unstructured data in PDF files which leads to redundancy and lengthy assessments. Using KASA will structure submission data that could be pre-processed for reviewers to make it more uniform – which in turn should improve the efficiency and consistency of regulatory quality assessments.
The FDA has stated that this review method is still in development phase and doesn’t have a timeline established yet. Draft guidance is usually the first step for industry to comment on the proposal before anything is decided.
Further deciding factors involve other international regulators such as the European Medicines Agency (EMA) which is aware of the FDA’s potential changes. Other PSCP committee members suggest that the FDA also work the International Council for Harmonisation (ICH).
Please check back with us as more information is released about the KASA review system. To read more, please go to this link on the FDA website here.
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