1. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for industry: quality systems approach to pharmaceutical CGMP regulations. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2006.
2. U.S. Department of Health and Human Services, Food and Drug Administration. Critical path opportunities for generic drugs. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2007.
3. Q8 (R1): Pharmaceutical Development, Revision 1. ICH Harmonized Tripartite Guidelines. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2007.
4. Hall G, Runas R. JPI Interviews Moheb Nasr, PhD. J Pharm Innov. 2007;2(3–4):67–70.
5. U.S. Department of Health and Human Services, Food and Drug Administration. Pharmaceutical CGMPs for the 21st century—a risk-based approach, final report. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2004.