Cornell University
Regulatory aspect of cardiovascular drug development discussed
Published in Medical Device Law Weekly, March 6th, 2005
According to a study from the United States, "The Food and Drug Administration (FDA) is responsible for assuring that drugs, devices, and biologicals available in the U.S. are effective and acceptably safe for their intended uses. Both law and regulation define the procedures to be followed by the FDA in judging the effectiveness and safety of therapies. The FDA comprises a cadre of highly skilled public servants who receive and evaluate all data collected by the manufacturer during therapy, not just the portion...
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