|
|
Article: Niel Constantine, Ph.D., University of Maryland School of Medicine, Baltimore, May 26 (CBER).(BLOOD/BIOLOGICAL DEVICES)
- Article from:
- Warning Letter Bulletin
- Article date:
- July 1, 2005
CopyrightCOPYRIGHT 2005 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
FDA investigators Stephanie Shapley and Janet White conducted an inspection Jan 25-Feb. 4 to determine if Constantine's activities as a clinical investigator, for an unnamed device study, were within regulations.
Several violations were found including that Constantine failed to ensure the rights, safety and welfare of the subjects under his care. The study, which was conducted at two locations at the university--Institute of Human Virology (IHV) and the Evelyn Jordan Center (EJC) - required that enrolled subjects be between the ages of 18 and 55 years and able to sustain venipuncture.
Subjects with certain life-threatening illnesses, as well as those ...
Related newspaper, magazine, and journal articles:
|
|
Article: Constantine's King Co. reform plan reaches out to ...
Seattle Post-Intelligencer (Seattle, WA);
September 24, 2009 ;
700+ words
... ... King County executive candidate Dow Constantine said Thursday there would be someone ... county has been too Seattle-centric. Constantine, joined by primary rival state Sen ... the people of our diverse region," Constantine said. He said his plan was detailed ...
|
|