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FDA clarifies 'shorter goal date' and expedited review benefits for priority ANDAs
Summary
Commander Andrew Kim explained that priority designations can shorten goal dates for original ANDAs (to eight months) and certain amendments/supplements, while minor amendments may instead receive expedited review without a goal-date change.
Commander Andrew Kim said the primary benefit of priority review is a shorter goal date: original ANDAs eligible for priority can receive an eight-month goal date instead of the standard ten-month review, major amendments may be eligible for six to eight months depending on inspection needs, and prior-approval supplements may receive four or eight months based on inspection or PFC timing.
"So that would mean that there's no change to the actual goal date, but FDA will strive to act as soon as possible, and they may complete the review prior to the goal date," Kim said when describing expedited review for minor amendments. He cautioned that if priority is granted later in a review cycle the agency will not retroactively shorten an already-assigned goal date; classification changes during a cycle can give only the expedited-review benefit for that cycle.
Kim emphasized that applicants should not treat priority designation as a guarantee of approval: review timelines still depend on application quality, and applicants should prioritize submitting a complete, high-quality application over relying solely on priority status.
