Clinical Pharmacology Subcommittee
(CPSC)
of the
Advisory Committee for Pharmaceutical
Science (ACPS)
CDER
Advisory Committee Conference Room
Topic 3:
Biomarkers
in the Critical Path and Their Use in Drug Development and Drug Product Labels
|
|
|
Update on the Critical Path Biomarker-Surrogate
Endpoint Project |
Janet Woodcock, M.D. Deputy Commissioner for Operations, FDA |
|
Use of Biomarker Information in Drug Product Labels
to Individualize Pharmacotherapy |
Director, OCPB, CDER, FDA |
|
Use of Biomarkers in Clinical Development and
Labeling: An Industry Perspective |
Douglas Mayers, M.D. Boehringer Ingelheim Pharmaceuticals, Inc. |
|
CDRH Perspective on Analytical and Clinical Considerations that go into a a “diagnostic
test”. Presentation of Case Studies
FDA Approval of |
Steven Gutman, M.D. Director, Office of In Vitro Diagnostics (OIVD) Center for Devices and Radiological Health (CDRH) |