Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule.

Kramer, Judith M; Vock, David; Greenberg, Howard E; Janning, Cheri; Szczech, Lynda; Salgo, Miklos; Gagnon, Suzanne; Ellenberg, Susan.

Afiliação

Kramer JM; Duke Translational Medicine Institute, Duke University School of Medicine, Durham, NC, USA ; Department of Medicine, Duke University School of Medicine, Durham, NC, USA ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Vock D; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA ; Dr. Vock is currently affiliated with the University of Minnesota, Minneapolis, MN, USA.
Greenberg HE; American College of Clinical Pharmacology, Rockville, MD, USA ; Department of Pharmacology and Clinical Therapeutics, Thomas Jefferson University, Philadelphia, PA, USA ; Dr. Greenberg is currently affiliated with Janssen Pharmaceuticals, Titusville, NJ, USA.
Janning C; Duke Translational Medicine Institute, Duke University School of Medicine, Durham, NC, USA ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Szczech L; Department of Medicine, Duke University School of Medicine, Durham, NC, USA ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA ; Dr. Szczech is currently affiliated with FibroGen Inc, San Francisco, CA, USA.
Salgo M; Genentech, South San Francisco, CA, USA ; Dr. Salgo has retired from Genentech.
Gagnon S; ICON Clinical Research, North Wales, PA, USA.
Ellenberg S; University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.

Ther Innov Regul Sci ; 48(4): 413-419, 2014 Jul.

Article em En | MEDLINE | ID: mdl-25419504