qualified data summary
(5) (A) The Secretary may rely upon qualified data summaries to support the approval of a supplemental application, with respect to a qualified indication for a drug, submitted under subsection (b), if such supplemental application complies with subparagraph (B). (B) A supplemental application is eligible for review as described in subparagraph (A) only if— (i) there is existing data available and acceptable to the Secretary demonstrating the safety of the drug; and (ii) all data used to develop the qualified data summaries are submitted to the Secretary as part of the supplemental application. (C) The Secretary shall post on the Internet website of the Food and Drug Administration and update annually— (i) the number of applications reviewed solely under subparagraph (A) or section 262(a)(2)(E) of title 42 ; (ii) the average time for completion of review under subparagraph (A) or section 262(a)(2)(E) of title 42 ; (iii) the average time for review of supplemental applications where the Secretary did not use review flexibility under subparagraph (A) or section 262(a)(2)(E) of title 42 ; and (iv) the number of applications reviewed under subparagraph (A) or section 262(a)(2)(E) of title 42 for which the Secretary made use of full data sets in addition to the qualified data summary. (D) In this paragraph— (i) the term “qualified indication” means an indication for a drug that the Secretary determines to be appropriate for summary level review under this paragraph; and (ii) the term “qualified data summary” means a summary of clinical data that demonstrates the safety and effectiveness of a drug with respect to a qualified indication.