On the one year anniversary of impletationtation of the Prescription Drug User Fee Act (PDUFA V), what element has shown the most promise?
Responses to this question were featured on the PhRMA website this month. One such response (see below) was offered by Dr. Rebecca D. Kush, Founder and President of CDISC.
Read more through this link: (
http://phrma.org/phrmapedia/conversations/one-year-anniversary-of-pdufa-v-shows- promise).
One particular element of PDUFA that has been the focus of promising progress during the past year is the commitment that FDA would work with an open, consensus-based standards development organization (i.e. CDISC) to develop standards/terminology for specific therapeutic areas (TA).
When FDA reviewers receive data in a standard format, a) they can begin their reviews sooner (since they readily understand what they receive and do not need to perform additional programming); b) they can use sophisticated tools to see graphic displays of the data (which need data in standard formats); and, c) they can essentially perform higher quality reviews on higher quality data.
To help address this PDUFA V goal, CDISC has increased its resources and expertise through partnerships and collaborations, redesigned its standards development process based upon lessons learned from prior TA standards development projects, and will offer a new tool to make the standards more readily accessible. Specifically, CDISC and the Critical Path Institute (C-Path) formed an initiative called the Coalition for Accelerating Standards and Therapies (CFAST); CFAST collaborators include the FDA, TransCelerate Biopharma, National Cancer Institute Enterprise Vocabulary Services, Association of Clinical Research Organizations, the Innovative Medicines Initiative and others depending upon the TA. These groups are working together in the development of TA standards, which augment the existing suite of global foundational CDISC standards that support research from protocol and data collection through analysis and reporting, including electronic submissions to FDA.
The first therapeutic area standards project initiated under CFAST is Asthma, which is currently available for public review. Standards for Diabetes and Multiple Sclerosis were also initiated early this year. Updates on the progress of all CDISC TA Standards can be found on the CDISC website.
Strength through Collaboration
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