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Least Burdensome Additional-Info Requests? US FDA Needs Metrics, GAO Says

The US Government Accountability Office says FDA needs more information to prove that is properly applying least-burdensome concepts for deficiency or additional-information letters sent to companies while reviewing pre-market submissions. FDA defends its performance, but plans to conduct more assessments.

The US FDA needs to get a better systematic handle on how well it is implementing the 20-year-old "least-burdensome" provisions with respect to requests for additional information during pre-market reviews, according to the US Government Accountability Office.

GAO says in a report posted Jan. 16 that FDA should establish formal performance metrics to evaluate how well it is implementing least-burdensome during submission reviews, and the agency...

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