Articles Commissioned by MDWG
” The 21st Century Cures Act, Section 3051: Ensuring Patient Access to Breakthrough Medical Devices,” Glenda M. Guest, February 2018, Journal of Clinical Research Best Practices

“The 21st Century Cures Act, Section 3024: Informed Consent Waiver or Alteration for Clinical Investigations,”  Glenda M. Guest and Norman M. Goldfarb, November 2017, Journal of Clinical Research Best Practices

“The 21st Century Cures Act, Section 3052: Humanitarian Device Exemption (HDE),” Judy Skroback, October 2017, Journal of Clinical Research Best Practices

Regulatory Documents

Other Resources