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Pharmaceutical Science and Clinical Pharmacology Advisory Committee

The US FDA has scheduled a Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP) meeting for Thursday, September 20, 2018. The meeting will focus on two topics related to the Office of Pharmaceutical Quality's priority of promoting the availability of better medicine.

During the morning session, the Committee will discuss the modernization of generic drug applications through a Knowledge-aided Assessment & Structured Application (KASA) initiative.

During the afternoon session, the Committee will discuss in-vitro/in-vivo relationship standards, and the FDA will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.