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FDA COULD DELAY PART 11 REVISION, OFFICIAL SAYS

Oct. 4, 2005

The FDA is unlikely to complete its long-awaited revision of 21 CFR Part 11 -- which regulates the use of electronic records and signatures -- by the end of the year as industry observers had expected, an agency official said this month.

"It's a very aggressive timeline, and the regulatory process is very cumbersome, so I have to say it will be difficult to meet that goal, but we are actually working hard toward it, and we have a lot of backing at the FDA keeping us moving along as best we can," said George Smith, consumer safety officer at the FDA's Center for Drug Evaluation and Research. "The point there is we really want to get it right," he told attendees at a recent Drug Information Association conference.

Pharmaceutical industry leaders have long complained that compliance with Part 11 was too costly and stifled innovation. The FDA formed a working group to address industry comments and consider revisions to the regulation.

Until the final regulation is promulgated, the FDA will continue to rely on the approach outlined in its scope and application guidance, Smith noted. "Once the final regulation is put out there ... we will subsequently take away the scope and application guidance, because that final regulation will address all of the petitions the scope and application guidance did," he said.