1. Enterprise UPHEMC. Public Health Emeregency Medical Countermeasures Enterprise (PHEMCE) Strategy. In: Services UDoHaH (2012).
2. Enterprise UPHEMC. Public Health Emeregency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan. In: Services UDoHaH (2012).
3. Project Bioshield Act of 2004, 6A USC, §201 (2004).
4. Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (“Animal Rule”). 21 C.F.R. §314.600 (revised 2014).
5. Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible (“Animal Rule”). 21 C.F.R. §601.90 (revised 2014).