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Biotech / Medical : SANGUINE CORP. (SGNC)
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To: Mike Ankley who wrote (3003)7/12/1998 3:06:00 AM
From: Mike Ankley  Read Replies (2) of 5402
 
Here's a couple links from the FDA site regarding the FDA's reinventing itself in order to speed up the approval process:
fda.gov
fda.gov

One excerpt from the second link is as follows:

Shortening Review Times for New Drugs and Devices

1) FDA now uses expert review panels to expedite the review of
certain biotechnology products. (For example, a joint committee of
FDA experts oversaw the licensing in record time of the drug
interferon beta 1b to treat certain patients with multiple sclerosis.)

2) Under the Prescription Drug User Fee Act of 1992, drugs are
now reviewed more quickly. This law authorizes FDA to charge user
fees for drug applications, and to use these additional resources for
the reviews of new drugs, vaccines, and biotechnology products.

Already, review times for new chemical drugs have dropped from an
average of 30 months in 1992 to 20 months in 1994.(1) By 1997, FDA
will be getting these products to market in a year or less, as fast as
or faster than anywhere else in the world, with no sacrifice in review
quality.

Cheers

Mike
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