Re: FDA Basics for Industry website

[Guest guest]

Hi Al ... yes I received a notice today on it too.

It is easier to find guidance documents now!

for example on when to convene an advisory committee:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125651.pdf

Karl

> > 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

>

>