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FDA Sponsor Liaison Program Is Not Being Used: Are Small Biotechs Missing An Opportunity? Or Partnering More?

This article was originally published in RPM Report

Executive Summary

FDA has noticed a perplexing – and somewhat vexing – trend among smaller, less experienced pharma companies: They are not taking full advantage of a new liaison program designed to increase sponsor/FDA communication – even when they hit roadblocks during the drug review process. FDA officials have heralded the program as one of the most important under PDUFA V. So why aren’t companies using it?


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