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FDA's electronic signatures/records rule benefits outweigh costs, agency says.

This article was originally published in The Tan Sheet

Executive Summary

ELECTRONIC SIGNATURES/RECORDS FINAL RULE COSTS OFFSET BY BENEFITS "to be realized by using trustworthy and reliable electronic records and electronic signatures," FDA tells the Pharmaceutical Research & Manufacturers of America in a March 9 response to association comments on the rule. The benefits include "decreased time to prepare premarket approval applications, decreased data storage costs, decreased FDA review time [and] improved operational efficiencies," FDA says.
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