FDA to hold “Drug Development Tool Process under the 21st Century Cures Act and Prescription Drug User Fee Act VI” public meeting

The FDA will hold a public meeting entitled “Drug Development Tool Process under the 21st Century Cures Act and Prescription Drug User Fee Act VI.” This meeting will provide an opportunity for public input regarding the drug development tools qualification pathway for animal models, biomarkers, and clinical outcome assessments.  

The FDA is holding this public meeting to discuss taxonomy for biomarkers and related concepts used in drug development, and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use.  

In addition to providing input at the public meeting, stakeholders are invited to submit comments through 

the public docket. Electronic or written comments can be submitted to the docket through January 31, 2019