C-Path receives $2 million grant to help streamline product approval

November 12, 2013

By hammersmith

The Critical Path Institute has received a $2 million grant from the Food and Drug Administration as part of the agency’s effort to support new standards that would streamline the process to evaluate and approve new safe and effective medical products.

The FDA’s two-year grant to C-Path is for its joint initiative with the Clinical Data Interchange Standards Consortium (CDISC) to strengthen the framework and further the objectives of the Coalition for Accelerating Standards and Therapies, known as CFAST.  CFAST is focused on developing data standards, tools, and methods for conducting research in therapeutic areas that are important to public health. 

The common CDISC standards provide a consistent way to collect and submit clinical trial data, allowing researchers, drug developers and regulatory agencies to aggregate and analyze clinical data more efficiently. 

Since 2011, the collective work of CDISC and C-Path has resulted in six new therapeutic area standards that are available today for Alzheimer’s disease, pain, Parkinson’s disease, polycystic kidney disease, tuberculosis, and virology.

For more information:

FDA awards $2M to C-Path for new data standards,” Drug Discovery and Development, 11/7/13