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CHPA, PhRMA Urge Part 11 Revocation In Citizen Petition

This article was originally published in The Tan Sheet

Executive Summary

FDA regulations governing electronic records and signatures in 21 CFR Part 11 are "unnecessarily burdensome" to firms and should be revoked completely, the Industry Coalition on Part 11 asserts in a citizen petition submitted to the agency the week of Sept. 20

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