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NDAs, BLAs To Start Getting KASA Quality Risk Assessments After Successful Pilot With ANDAs

 
• By Kate Rawson

Internal review system reduces US FDA’s administrative work for OPQ risk assessments; agency’s standards will not change, and sponsors will not need to modify applications. Advisory committee endorses expansion, which will roll out to different application types over several years.

better risk assessment tools
better quality risk assessment tools coming to more reviews • Source: Shutterstock

The US Food and Drug Administration, which has been using its recently developed Knowledge-Aided and Structured Application risk assessment review system for generic drug quality reviews, is preparing to expand KASA’s use to reviews of new drugs and biologics now that it has received a formal sign-off from the agency’s Pharmaceutical Science & Clinical Pharmacology Advisory Committee.

A 3 November advisory committee meeting provided FDA an opportunity to update members and the public on progress made on...

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