Tom, there is a pretty good explanation of the whole process which includes
a detailed description of the phases in a document entitled "From Test Tube
to Patient: New Drug Development in the United States". The copy I have
was last revised in Mar. 1990. It is published by DHHS, publication No.
90-3168. I found it very useful when I needed the same info.
>Does anybody have handy or know where I could definitions of the
>different phases of FDA approval for clinical trials? Any help or
>suggestions would be greatly appreciated. Thanks.
>********************************************************************
>
>
>Thomas J. Roberts, Assistant Director for Research
>University of Florida, College of Medicine
>Phone (904) 392-5398, Fax (904) 392-7427
>e-mail "xxxxxx@dean.med.ufl.edu"
****************************************
Norman J. Hebert
Assistant Director, Contract Admin.
Brown University
Office of Research Administration
phone: (401) 863-3141
fax: (401) 863-7292