1. Food and Drug Administration Amendments Act, PL 110-85, §901 et seq.,121 Stat. §926–939.
2. Food and Drug Administration. Guidance for industry: format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications: draft guidance;Accessed at ,8 April,http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf",www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf,2011
3. Food and Drug Administration Amendments Act, PL 110-85, §901 et seq.,121 Stat. §926
4. Food and Drug Administration Amendments Act, PL 110-85, §901 et seq.,121 Stat. §930.
5. Presented at Annual Meeting of the American Pharmacists Association,28 March;Bough;REMS update.,2011