The FDA produces a good magazine called "FDA Consumer". I got a free issue
when I applied for an investigational new drug packet a couple of months
ago. The IND packet and the magazine define the Phases of clinical trials
very well in my opinion. Also, the OPRR Human Studies Guidebook has several
definitions of Phase I, Phase II, Phase III clinical trials.

You can get the IND packet and a free "FDA Consumer" magazine from The Center
for Drug Evaluation and Research, CDER Executive Secretariat (HFD-8), 5600
Fishers Lane, Rockville, MD, 20857. I found that it is best to Fax yourequest fo
for an IND Packet at (301) 594-3302. If you call CDER, you will probably get
voice mail and be a long time getting your request. FAX your request.

Sincerely,

Tim Atkinson
Grants Review Officer
IRB Executive Secretary
Meharry Medical College
Nashville, TN 37208
xxxxxx@ccvax.mmc.edu