; and (vii) the Secretary finds that none of the grounds for denying approval specified in subsection (d) applies. (B) Limitations Approval of a drug under this section may, as the Secretary determines appropriate, be subject to 1 or both of the following requirements: (i) The sponsor conduct appropriate postapproval studies to verify and describe the predicted effect of the drug on irreversible morbidity or mortality or another clinical benefit of the drug. (ii) The sponsor submit copies of all promotional materials related to the drug 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 the dissemination of the materials. (C) Timeline If the Secretary does not approve the application or take such other action within such 90-day period, the application shall be considered approved under this subsection. (D) Advisory committee (i) Establishment For the purpose of providing expert scientific advice and recommendations to the Secretary regarding the approval of applications described in subsection (b)(7), the Secretary shall establish a standing Foreign Drug Review Advisory Committee. (ii) Membership The standing Foreign Drug Review Advisory Committee established under clause (i) shall consist of employees of the Food and Drug Administration and individuals appointed by the Secretary, reflecting a balanced composition of sufficient scientific expertise. The Secretary shall appoint members who have diverse interests, education, training, experience, and expertise in biopharmacology, statistics, chemistry, legal issues, ethics, and other appropriate expertise pertaining to the drugs under review, such as expertise in foreign regulatory and manufacturing practices and drug development, and other individuals, as the Secretary determines appropriate. (iii) Review of applications Upon the filing of an application described in subsection (b)(7)— (I) the Secretary shall immediately refer the application to the