Hi Sid and All, I found a little more... Milestones in U.S. Food and Drug Law History http://vm.cfsan.fda.gov/mileston.html The FDA CDER Handbook Online http://www.fda.gov/cder/handbook/index.htm Discovering and developing safe and effective new medicines is a long, difficult, and expensive process. The research-based pharmaceutical industry expects to invest $24 billion in research and development in 1999. Once a new compound has been identified in the laboratory, it undergoes the drug development process before it can be marketed for public use. The entire drug development process can be summarized in a series of steps or charts. Drug Development Steps: http://www.pharmquest.com/source/ddg/steps/index.html The Drug Development Charts: http://www.pharmquest.com/source/ddg/charts/index.html July 30, 1999 print edition Study: FDA stepping up its drug approval process http://www.bizjournals.com/boston/stories/1999/08/02/story4.html (when you get to the end - click on related stories for 20 more...) Map of Speed Up FDA The goal of this web site is to explain the general principles of how the review process and reviewers work. http://www.speedupfda.com/ Reform of FDA's Approval Process Is Extended http://respiratorycare.medscape.com/jobson/MedTrib/obgyn/1998/v05.n01/ReformofFDA%27sAppr ovalProce.html Women TLC - FDA Drug Approval Process http://womentlc.com/fdaapprovalprocess.html Drug Rush Why the prescription drug market is unsafe at high speeds http://www.washingtonmonthly.com/features/2000/0005.pomper.html "FDA Reform: A Consumer Perspective." http://www.nclnet.org/ohio.htm What's the rush: FDA needs to slow drug approval process and not be pressured http://www.mainquad.com/theQuad/properties/uwire/page2.0/staging/oped09269713.chtml The FDA's Deadly Quick-Approval Process http://www.americanprospect.com/columns/kuttner/bk980628.html Generic Drug Product Development and Approval Process http://www.gpia.com/edu_approval.html FDA Approval Process for Generic Medications http://www.stadtlander.com/general/generics.html This has been a very interesting "study". Best regards ......... murray [log in to unmask]