Division of Clinical Research

Office of the Vice President and Innovation

(5/11/2020) The U.S. Food and Drug Administration added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators and institutional review boards.

New QAs included:

  • Q18. I am a sponsor and would like to use an alternate laboratory or imaging center for protocol assessments. What should I consider regarding when this approach would be appropriate and the selection of alternate laboratories or imaging facilities?
  • Q19. We are instituting trial participant visits remotely through video conferencing. Are there recommendations regarding best practices?
  • Q20. How does the COVID-19 public health emergency affect drug and biological product clinical trials required as postmarketing requirements (PMRs)? What about for required postmarket device studies?

See document here: https://www.fda.gov/media/136238/download

Categories COVID-19, FDA Regulatory

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