 Walter
Modell |
|
The
Drug Amendments also addressed the use of drugs in clinical trials, including a
requirement of informed consent by subjects. FDA had to be provided with full details of
the clinical investigations, including drug distribution, and the clinical studies had to
be based on previous animal investigations to assure safety. FDA formed the first advisory
committee, the Advisory Committee on Investigational New Drugs, for assistance in
implementing the new law. The Committee, chaired by Walter Modell of Cornell University,
served as a de facto interface between FDA and clinical investigators and other scientists
around the country |
