Print

Print


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]