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Electronic Records/Signatures Rule Being Reexamined By FDA

This article was originally published in The Tan Sheet

Executive Summary

Industry concerns about FDA's electronic records and signatures regulation - namely, the economic impact, industry practices and enforcement pertaining to the rule - are being considered by the agency, Center for Drug Evaluation & Research Office of Compliance Director Stephanie Gray told industry reps at the Consumer Healthcare Products Association's Manufacturing Controls Seminar in Philadelphia Oct. 7-8.

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Electronic Signature/Record Exemptions Suggested By CHPA

An FDA guidance on possible areas of exemption from the agency's rule on electronic signatures and electronic records would be a useful, cost-saving tool for industry, according to the Consumer Healthcare Products Association.

Electronic Signature/Record Exemptions Suggested By CHPA

An FDA guidance on possible areas of exemption from the agency's rule on electronic signatures and electronic records would be a useful, cost-saving tool for industry, according to the Consumer Healthcare Products Association.

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