Pub. L. 114-255, div. A, tit. III, subtit. A, sec. 3004 (as amended)

REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT.

Year: 2022Length: 112 wordsOfficial source
SEC. 3004. [21 U.S.C. 355 note] REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT. Not later than June 1 of 2021, 2026, and 2031, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall prepare and publish on the Internet website of the Food and Drug Administration a report assessing the use of patient experience data in regulatory decisionmaking, in particular with respect to the review of patient experience data and information on patient-focused drug development tools as part of applications approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).
Cross-references to the US Code
21 U.S.C. 355 note
Pub. L. 114-255, div. A, tit. III, subtit. A, sec. 3004 (as amended): REPORT ON PATIENT EXPERIENCE DRUG DEVELOPMENT. | Justis AI