RE: Story cards "ain't going to happen here"

Aren't there FDA regs with a number I can look at?

Glen B. Alleman 

> -----Original Message-----
> From: Arien 
> FDA just says you have to have the data available for a certain period
of
> time
> (pharma companies extend that period of time, since they may need the
data
> for
> product defense). I don't know of any guidance document that covers
> archive:
> that's for industry to figure out. (That's changing slowly: it used to
be
> that
> you'd only know when you'd violated the rules, not what the rules
were,
> but
> slowly guidance is being created).
> 
> Arien
> 
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