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FDA warns applicants: request priority at submission and re-request it each cycle
Summary
Commander Andrew Kim warned that failing to request priority at submission or assuming priority persists across cycles are common mistakes; cover letters should clearly state the request, prioritization factor, and include the ANDA number and documentation.
Commander Andrew Kim identified two common and avoidable mistakes: (1) failing to request priority at the time of submission and (2) assuming a previously granted priority designation continues through subsequent review cycles. He said FDA evaluates each submission when received and assigns the goal date during initial processing, so a late request may be too late to obtain the shorter goal date.
"So the number 1 mistake that we see is a timing issue. So you have to make your priority review request at the time of submission," Kim said. He added that applicants who received priority in an earlier cycle must request it again on later cycles because designations and drug-shortage listings can change over time. Kim also emphasized practical cover-letter details: explicitly state 'priority review requested,' cite the factor or onshoring pilot if relevant, include the ANDA number, and attach supporting documentation to facilitate processing.
Kim noted facilities with an Official Action Indicated or Withhold status are generally ineligible for priority review except in case-by-case public-health-emergency evaluations, so applicants should resolve outstanding compliance issues before seeking priority.
