; (E) absent reciprocal marketing approval, the drug is not approved for marketing in the United States; (F) the Secretary has not, because of any concern relating to safety or effectiveness, rescinded or withdrawn any such approval; and (G) there is a public health or unmet medical need for the drug in the United States. (2) Limitation Approval of a drug under this section may, as the Secretary determines appropriate, be subject to 1 or both of the following requirements: (A) The sponsor conduct appropriate postapproval studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit of the drug. (B) The sponsor submit copies of all promotional materials related to the product during the preapproval review period and, following approval and for such period thereafter as the Secretary determines to be appropriate, at least 30 days prior to dissemination of the materials. (c) Timeline The Secretary shall make a determination on an application described in subsection (a) not later than 180 days after the date of submission of such application. .