1. 21st Century Cures Act. Accessed on 06 Sep 2023 at https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf
2. Food and Drug Administration Safety and Innovation Act 2012. Accessed on 06 Sep 2023 at https://www.govinfo.gov/content/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf
3. FDA Reauthorization Act of 2017. Accessed on 06 Sep 2023 at https://www.congress.gov/bill/115th-congress/house-bill/2430.
4. Eastern Research Group Report, June 18, 2021. Assessment and the Use of Patient Experience Data in Regulatory Decision-making. Accessed on 05 Sep 2023 at https://www.fda.gov/media/150405/download?attachment.
5. Patient-reported outcome measures: use in medical product development to support labeling claims: guidance for industry 2009. US Food and Drug Administration. Accessed on 07 Feb 2023 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims