FDA strategic plan on domestic inspection improvements for biosimilar biological facilities

Not later than 1 year after the date of enactment of this Act, the Secretary shall develop and publish a strategic plan on ways the Food and Drug Administration will address challenges with respect to the inspection of domestic biosimilar biological product establishments, including regarding— (1) recruiting and retaining inspections staff; (2) challenges specific to inspecting domestic biosimilar biological product establishments; (3) improving internal communication among all Food and Drug Administration personnel involved in inspections of biosimilar biological product establishments; and (4) expanding opportunities for external communications with sponsors of applications under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), including informing such sponsors about potential inspection requirements and resolving outstanding inspection related questions earlier in the review process.