1. 21 US Code sec. 321 355
2. US Food and Drug Administration.Development and approval process (drugs).2018.https://www.fda.gov/drugs/developmentapprovalprocess/default.htmAccessed 29 May 2019.
3. 21 C.F.R. sec. 202.1
4. 21 US Code sec. 314.81(b)(3)(i)
5. US Food and Drug Administration.OPDP Frequently Asked Questions.2015.https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090308.htmAccessed 29 May 2019.