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Background Analysis: US FDA Advisory Committee to Give Input on Modern Format for Generic Drug Applications, In-Vitro/In-Vivo Relationship Standards, and Dissolution Standards for Drugs with Oral Solid Modified-Release Dosage Formulations – SEP 20, 2018 (PSCP)


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.

Background and Agenda

The Knowledge-aided Assessment & Structured Application (KASA) is a proposed modernized format for generic drug applications. The intent of the new format is to allow for earlier FDA identification of application deficiencies and increased first cycle review approval. Currently, multiple review cycles are a primary factor in delaying the market entry of new generics. The KASA format moves away from the current text and narrative-based format and toward a data-based format that allows for some portions of applications to be reviewed automatically rather than manually. The FDA believes the KASA format will improve consistency and save time. In addition, the new format is meant to extend seamlessly to the postmarket phase, improving on the quality of postmarket surveillance of drug quality and risk.

FDA Commissioner, Dr. Scott Gottlieb, blogged about the KASA format on June 18, 2018. He explained that the development of the KASA format is one of several FDA initiatives under the Agency’s Drug Competition Action Plan. This plan aims to advance policies that promote robust generic drug entry as a way to foster competition and lower drug prices.

In the morning session of the meeting, the FDA will seek input from PSCP on the KASA format.

In the afternoon, the Committee will shift its focus to discuss in-vitro/in-vivo relationship standards and provide input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.

What’s Next? (With Subscription)

Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none

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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.