Emanuel F. Petricoin III1, Joseph L. Hackett2, Lawrence J. Lesko3, Raj K. Puri4, Steven I. Gutman5, Konstantin Chumakov6, Janet Woodcock7, David W. Feigal Jr.8, Kathryn C. Zoon9
& Frank D. Sistare101
Division of Therapeutic Products, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland 20892, USA.
2
Division of Clinical Laboratory Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Rockville, Maryland 20850, USA.
3
Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, FDA, Rockville, Maryland 20857, USA.
4
Division of Cell and Gene Therapy, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland 20892, USA.
5
Division of Clinical Laboratory Devices, Office of Device Evaluation, Center for Devices and Radiological Health, FDA, Rockville, Maryland 20850, USA.
6
Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland 20892, USA.
7
Office of the Director, Center for Drug Evaluation and Research, FDA, Rockville, Maryland 20852, USA.
8
Office of the Director, Center for Devices and Radiological Health, FDA, Rockville, Maryland 20850, USA.
9
Office of the Director, Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland 20892, USA.
10
Division of Applied Pharmacology Research, Office of Testing and Research, Center for Drug Evaluation and Research, FDA, Laurel, Maryland 20708, USA.
Correspondence should be addressed to Emanuel F. Petricoin III petricoin@cber.fda.gov or Frank D. Sistare sistare@cder.fda.gov
