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Staffing woes hamper FDA; but approvals remain high

This article was originally published in Scrip

Executive Summary

It may be difficult for the FDA to convince Congress the agency is struggling to get its work done because of staffing and resource shortages when juxtaposed against that complaint is the fact the agency is on track to have a banner year in getting new molecular entities (NMEs) and novel therapeutic biologics approved – many of them sooner than expected.

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