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.