Department of Health and Human Services
Food and Drug Administration
- [Docket No. FDA-2015-N-2390]
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of public meeting; request for comments.
SUMMARY:
The Food and Drug Administration (FDA), in collaboration with the University of Maryland's Center of Excellence in Regulatory Science and Innovation and the Critical Path Institute, is announcing a public workshop entitled “Evidentiary Considerations for Integration of Biomarkers in Drug Development.” The purpose of the meeting is to discuss current scientific approaches to biomarker development, acceptance, and utility in drug and biologic (hereafter referred to as therapeutic product) development programs.
DATES:
The meeting will be held on August 21, 2015, from 9 a.m. to 5 p.m.
ADDRESSES:
The meeting will be held at the University of Maryland, Pharmacy Hall, 20 North Pine St., Baltimore, MD 21201. For additional travel and hotel information, please refer to www.pharmacy.umaryland.edu/cersibiomarkers. (FDA has verified the Web site addresses throughout this notice, but FDA is not responsible for subsequent changes to the Web sites after this document publishes in the Federal Register ).
FOR FURTHER INFORMATION CONTACT:
Ann Anonsen, University of Maryland, Fischell Dept. of Bioengineering, 2207 Jeong H. Kim Bldg., College Park, MD 20742, 301-405-0285, FAX: 304-405-9953, aanonsen@umd.edu.