19 September 2018 - The US FDA has issued more complete responses for abbreviated new drug applications in 2018 than any other year, and the numbers are not even close.

But the gap between this year and years past – 2,515 complete responses have been issued so far in 2018 vs. 1,603 in FY 2017 and 1,725 in FY 2016 – may be attributed to a spike in applications or other reasons.

David Gaugh, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines, told Focus: “Year one of GDUFA II, and the volume of completed responses, are performing consistent with expectations that were set when the new goals and metrics were negotiated. It’s important to note that as part of the migration to GDUFA II, there was a bridging process that established a goal date of July 31, 2018 for the approximately 800 applications that did not have an official goal date in GDUFA I, which very likely accounts for the perceived surge in overall applications over this time period.”

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