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FDA says it exceeded GDUFA 3 petition-review target; reported 94% of suitability petitions completed on time
Summary
FDA presenters reviewed GDUFA 3 review-time commitments for suitability petitions and reported that last year the office completed roughly 94% of reviews on time, surpassing its 2027 target.
Karen Rothschild reviewed the agency's GDUFA 3 commitments on suitability petition review timelines and said the office has been meeting and exceeding those metrics.
"Well, as you can see from the slide, we're really pleased to say that we actually have surpassed our ultimate goal for 2027. We have last year, we reviewed more than 90. It was 94, and we got them all done on time," Rothschild said, summarizing the office's recent performance and advising applicants they can generally expect a final response within six months.
Rothschild added that the office has received about 100 suitability petitions over the last couple of years and that filing and tracking procedures (docket numbers and accurate labeling documentation) help avoid delays in meeting those timelines.
