1. Issue Information
2. Code of Federal Regulation Title 21 Part 314 Section 50 of the 4‐1‐86 Edition.
3. US FDA Final Rule.63 FR 6854. 21 CFR 312 and 21 CFR 314: investigational new drug applications and new drug applications. (Demographic Rule) Federal Register 1998;63:6854–6862.
4. GUIDANCE DOCUMENT: format and content of the clinical and statistical sections of an application. US FDA. Accessed February 20 2024.https://www.fda.gov/media/71436/download
5. US Government.PUBLIC LAW 112–144—JULY 9 2012. Accessed February 20 2024.https://www.congress.gov/112/plaws/publ144/PLAW-112publ144.pdf