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FDA staff outline how to request priority review for ANDAs and supplements
Summary
FDA presenters explained the criteria and internal steps for priority review of original ANDAs, amendments, and supplements, emphasized documentation and timing, and described who within FDA evaluates and validates requests.
Bailey Larson, a member of the patent and exclusivity team in the Office of Generic Drug Policy, told applicants that a request for priority review must include four elements: a cover letter stating priority review is requested with the ANDA number, a basis consistent with one factor in the agency's MAP, a concise statement of the factor, and sufficient supporting documentation.
"When submitting a request for priority review, all of the following criteria must be met for your ANDA or supplemental ANDA to be considered," Larson said, listing the cover-letter, factor-consistency, concise basis, and documentation requirements. She cautioned that, except for limited statutory exceptions, FDA generally will not evaluate a priority review without an explicit applicant request at the time of submission.
Commander Andrew Kim of the Office of Regulatory Operations explained the internal steps after submission: FDA assigns an identifier and a validator, coordinates among review disciplines (OGD, OPQ, labeling, RPMs), and then grants or denies priority after consultation. If granted, FDA issues an acknowledgment letter with the shorter goal date; for expedited review designations the project is labeled to notify review disciplines.
Kim also stressed roles and responsibilities: OGD regulatory project managers apply the prioritization policy and coordinate across offices; OPQ RBPMs manage OPQ supplements; and OGD filing-review staff identify prioritization requests during filing. He reiterated that priority status does not guarantee approval and that application quality remains critical.
