Webinars

Fast Track to Market – Possible Pathways for FDA Approval or Authorization During COVID-19

Thursday, June 11, 2020
02:30 PM - 03:30 PM Eastern Daylight Time
01:30 PM - 02:30 PM Central Daylight Time
11:30 AM - 12:30 PM Pacific Daylight Time

As part of the global fight against coronavirus (COVID-19), FDA is working closely with medical product sponsors and investigators to find a potential treatment. As part of these efforts, multiple FDA expedited pathways may be available to the medical product industry and healthcare providers for the study and use of COVID-19 treatments. Join us for a presentation discussing those pathways.

TOPICS WILL INCLUDE:

  • Expanded access (compassionate use)
  • Right-to-try
  • Emergency use authorization
  • Coronavirus Treatment Acceleration Program (CTAP)
  • Related FDA guidance documents

CLE credit: CLE credit in CA, IL, MA, NJ (via reciprocity), NY, PA, TX, and VA is currently pending approval.