Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program

Lignende værker

• Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
  af: Zheng, Sarah Y., et al.
  Udgivet: (2017)
• Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices
  af: Dhruva, Sanket S., et al.
  Udgivet: (2017)
• Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices
  af: Ong, Caroline, et al.
  Udgivet: (2020)
• Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death
  af: Lalani, Christina, et al.
  Udgivet: (2021)
• Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports
  af: Chang, Lee, et al.
  Udgivet: (2015)