1. 5 U.S.C. §§551, 553, 701–06, generally; see also 21 U.S.C. §§701(a), 701(e), specifically.
2. Szalados JE. Statutory and regulatory controls. In: Clark ME. ed. Pharmaceutical law: regulation of research, development, and marketing. BNA Books; Arlington, VA, 2007. p. 1–120.
3. Szalados JE. Statutory and regulatory controls for drug development. In: Clark ME, editor. Pharmaceutical law: regulation of research, development, and marketing – 2008 Supplement. BNA Books; Arlington, VA, 2008. p. 1–22.
4. 5 U.S.C. §551(4) (2005).
5. 5 U.S.C. §551(5) (2005).