1. Legal issues in the practice of critical care medicine: a practical approach;Szalados;Crit Care Med,2007
2. 21 U.S.C. §§307–399.
3. “Statutory and Regulatory Controls” in Pharmaceutical Law: Regulation of Research, Development, and Marketing;Szalados,2007
4. Pub. L. No. 94-295, 90 Stat. 538 (1976).
5. Generally see 21 C.F.R. 800 – 1299.