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How FDA Says Its KASA Plan Will Streamline Quality Reviews

 
• By Joanne S. Eglovitch

FDA officials described some of the work being done to advance its KASA initiative, under development to make it easier for reviewers to evaluate, and for applicants to submit, quality information in applications. They compared KASA, with its pre-populated data and drop-down menus, to tax return software.  

Royalty-free stock photo ID: 225332590 Computer key - Copy / Paste

US FDA officials April 9 explained and touted the benefits of the agency's still-evolving knowledge-aided assessment and structured application (KASA) program at a meeting in Rockville, Maryland, sponsored by FDA and the Product Quality Research Institute, a consortium of regulatory, pharmacopeial, academic and pharmaceutical industry organizations that focuses on emerging scientific and regulatory quality challenges.

By switching, where possible, from text to data, the KASA initiative should make it easier for industry to submit quality information in drug applications, and for reviewers to locate the quality information industry submits, agency officials told the FDA/PQRI drug quality conference

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