FDA Basics for Industry website

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Re: Re: FDA criteria & " Non-Inferiority " trials

At 08:08 AM 1/6/2011, " karlamonyc " wrote:

> I agree 100% regarding the need for advocates to first have at

> least a working understanding of the regulations that guide the

> drug review process, including the rationale for independent review.

In the spirit of gaining a working understanding, but from the

perspectives of sponsors of CLL drugs, the FDA, this month, set up a

new website " FDA Basics for Industry " at:

http://www.fda.gov/ForIndustry/FDABasicsforIndustry/default.htm

I just learned of this website from a friend who is an FDA employee,

and have not had a chance to examine the degree of its

values. However, it could be quite useful.

Al Janski