Part 11 draft guidance withdrawn
This article was originally published in The Gray Sheet
Executive Summary
FDA rescinds November draft guidance entitled "Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records," in light of Good Manufacturing Practice initiative for drugs and biologics, announced in August (1"The Gray Sheet" Aug. 26, 2002, p. 3). "The agency wishes to limit the time spent by industry reviewing and commenting on the guidance, which may no longer represent FDA's approach under the cGMP initiative," FDA explains in Feb. 4 Federal Register notice. Comments would have been due Feb. 10 (2"The Gray Sheet" Nov. 18, 2002, p. 12)...