Re: FDA Definitions Norm Hebert 28 Jun 1995 15:57 EST

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