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...
