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Pharmaceutical Science and Clinical Pharmacology Advisory Committee

The committee discussed and voted on two topics related to the Office of Pharmaceutical Quality's priority of promoting the availability of better medicine. The first topic was the modernization of generic drug applications through a Knowledge-aided Assessment & Structured Application (KASA) initiative. The committee members were unanimous, by a vote of 10-Yes to 0-No, with no abstentions, in their support of the development of a structured application as a part of the KASA initiative. The second topic involved the establishment of patient focused quality standards for extended-release solid oral drug products. The committee members were unanimous, by a vote of 11-Yes to 0-No, with no abstentions, in their recommendation that the FDA establish patient-focused dissolution standards for extended-release solid oral dosage forms. Note that one of the members of the committee attended and voted only in the Topic II session..