About Us | Nora Roselle

Dr. Roselle joined DSI as Managing Director of U.S. Regulatory Affairs in 2007. Prior to DSI, she served as an officer (LCDR) in the U.S. Public Health Service. She joined the Food and Drug Administration (FDA) in 2001 as a Safety Evaluator in the Division of Medication Errors and Technical

Support (DMETS), in the Office of Drug Safety (ODS), recently renamed the Office of Surveillance and Epidemiology (OSE). In that role, she evaluated a multitude and diverse array of applications for brand names, line extensions and combination product names utilizing DMETS’ proprietary name evaluation methodology.

In July of 2006, she was promoted to a more senior management position as a Team Leader in DMETS. As Team Leader, Dr. Roselle managed DMETS safety evaluators, and oversaw proprietary (brand, line extension, and combination product) name reviews and labeling, risk management consults.

Dr. Roselle has published several articles on medication errors. Two of her most widely known name safety articles include, “Metadate ER or Metadate CD?; Drug Topics 2004, Oct 11:62,64” and “Confusion between Methylphenidate and Methadone, Patient Care 2003, Jan 15:76.”

Dr. Roselle earned a Doctor of Pharmacy from the University of Maryland (with Honors) and a B.S. in Biology with a Chemistry Minor from the University of Akron (Cum Laude).

Nora’s responsibilities at DSI include assisting clients with their U.S. proprietary brand and line extension strategy, naming, safety research, labeling, risk management, name submissions, rebuttals and special consults.