PATIENT EXPERIENCE DATA.

SEC. 605. PATIENT EXPERIENCE DATA. Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c(c)(2)(A)) is amended by striking “impact of such disease or condition, or a related therapy,” and inserting “impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation”.131 STAT. 1049