CLINICAL INVESTIGATIONS.

SEC. 115. CLINICAL INVESTIGATIONS. (a) Clarification of the Number of Required Clinical Investigations for Approval.—Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: “If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for purposes of the preceding sentence.”. (b) Women and Minorities.—Section 505(b)(1) (21 U.S.C. 355(b)(1)) is amended by adding at the end the following: “The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).”.