1. US Food and Drug Administration Modernization Act of 1997. 105th Congress, PL 105-115, 21 USC 301 (1997); 2007 (Feb 21). https://www.gpo.gov/fdsys/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf. Accessed July 25, 2018.
2. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients—FDA. Final rule. Fed Regist. 1998;63(231):66631-66672. https://wayback.archive-it.org/7993/20170405140724/https://www.fda.gov/ohrms/dockets/ac/03/briefing/3927B1_05_1998%20Pediatric%20Rule.htm. Accessed July 25, 2018.
3. Arshagouni P. Federal Court invalidates the FDA pediatric rule: AAPS v. FDA. 2002. https://www.law.uh.edu/healthlaw/perspectives/Children/021223Federal.html. Accessed July 25, 2018.
4. Best Pharmaceuticals for Children Act, 21 USC 301 (2002)
5. 21 USC 301 (Pub L No. 107-109). http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ109.107. Accessed July 25, 2018.