FDA Announces Advisory Committee Meeting on Modernizing Drug Application Assessments

The FDA has scheduled a Sept. 20 advisory committee meeting on modernizing drug application assessments through its knowledge-aided assessment and structured application (KASA) initiative.

The review initiative introduced by FDA Commissioner Scott Gottlieb in June allows the agency to provide feedback to generic drugmakers earlier in the development process and reduce delays stemming from multiple cycles of review.

In the meeting’s morning session, the FDA will accept feedback on potentially improving quality assessments by using a submission format consistent with the KASA initiative. In the afternoon session, the committee will discuss in-vitro/in-vivo relationship standards and will accept input on patient-focused dissolution standards for solid oral modified-release dosage forms.