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I don't think it's quite accurate to say that the FDA
regulations change all that frequently. 21 CFR Part 11
was instituted in 1997 and it took over 5 yrs for the
FDA to decide that electronic submissions were acceptable.
However, the agency interpretation of what procedures
industry needs to follow to *comply* with regulations is
indeed fluid. Changes occur in part because of changing
political landscapes, but also in part because industry
itself is constantly petitioning for various changes.
Gene Kim-Eng
------- Original Message -------
On
Wed, 18 Jun 2003 11:12:24 -0600 Richard G. Combs?wrote:
Nonsense. New drugs and devices don't require new regulations. In fact,
that's back-asswards. Drugs and devices are developed and tested in
accordance with the _existing_ regulations; they have to be, unless the
developers are required to be prescient.
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