1. Rose K, Walson PD. Do paediatric investigation plans (PIPs) advance paediatric healthcare? Paediatr Drugs. 2017;19(6): 515–522.
2. Rose K, Grant-Kels JM. Pediatric melanoma and drug development. Children (Basel). 2018;5(3).
3. Janssen WM. A historical perspective on off-label medicine: from regulation, promotion, and the First Amendment to the next frontiers. In: Levy MC, ed. Off-Label Communications. Washington, DC: Food and Drug Law Institute; 2008.
4. Rägo L, Santo B. Drug regulation: history, present and future. In: van Boxtel CJ, Santo B, Edwards IR, eds. Drug Benefits and Risks: International Textbook of Clinical Pharmacology. Rev. 2nd ed. Uppsala, Sweden: IOS Press & Uppsala Monitoring Centre; 2008:65–77.
5. Hilts PJ. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred A. Knopf; 2003.