9 Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition
rtA-sec355-1&packageId=USCODE-2010-title21&collapse=true&fromBrowse=true. Accessed 24
August 2018.
28. Format and Content of a REMS Document: Guidance for Industry. FDA website. September 2009. www.
fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf.
Accessed 12 August 2018.
29. FDA’s Application of Statutory Factors in Determining When a REMS is Necessary: Draft
Guidance for Industry (September 2016). FDA website. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM521504.pdf. Accessed 12 August 2018.
30. Op cit 28.
31. Op cit 29.
32. McCaughan M. The REMS era begins: FDA applies soft touch with new drug safety tools. The RPM
Report. 2008 3(11):1–12.
33. Op cit 27.
34. Ibid.
35. Op cit 3.
36. McCaughan M. Regulatory alchemy: The transformative power of the opioid REMS. The RPM Report.
2011 4(8):1–8. [In hard copy: 6:6: 12-19, June 2011].
37. Ibid.
rtA-sec355-1&packageId=USCODE-2010-title21&collapse=true&fromBrowse=true. Accessed 24
August 2018.
28. Format and Content of a REMS Document: Guidance for Industry. FDA website. September 2009. www.
fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf.
Accessed 12 August 2018.
29. FDA’s Application of Statutory Factors in Determining When a REMS is Necessary: Draft
Guidance for Industry (September 2016). FDA website. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM521504.pdf. Accessed 12 August 2018.
30. Op cit 28.
31. Op cit 29.
32. McCaughan M. The REMS era begins: FDA applies soft touch with new drug safety tools. The RPM
Report. 2008 3(11):1–12.
33. Op cit 27.
34. Ibid.
35. Op cit 3.
36. McCaughan M. Regulatory alchemy: The transformative power of the opioid REMS. The RPM Report.
2011 4(8):1–8. [In hard copy: 6:6: 12-19, June 2011].
37. Ibid.