The US Food and Drug Administration (FDA) is now piloting its Knowledge-aided Assessment and Structured Application (KASA) drug review program for drug substances as part of its effort to improve quality reviews of drug applications and speed products to market.
The review program has already been implemented in abbreviated new drug applications (ANDAs) for solid oral dosage forms.
FDA’s Hong Cai, division director for the Office of New Drug Products in the Center for Drug Evaluation and Research (CDER), discussed some of the agency’s review challenges and how KASA will be used to help overcome some of these obstacles during the Pharmaceutical Quality Symposium sponsored by the Small Business and Industry Assistance (SBIA) program at CDER, held on 31 October…
