FDA, CTTI Convening Virtual Public Workshop to Discuss FDA Emergency Recommendations to Mitigate Clinical Study Disruptions

The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual public meeting on Oct. 18 and 19, 2023 to discuss recommendations provided by the FDA during the COVID-19 public health emergency (PHE) to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards.”

Registration for the meeting is now open.

We are inviting those who register to submit questions for our speakers and panelists in advance of the meeting. Please click here to submit your questions.

The meeting will also include discussions with representatives from the FDA, pharmaceutical and medical device industries, academia, research study teams, patients, and patient advocacy groups, and other federal agencies, who will share the experiences, best practices, and approaches they used to effectively navigate disruptions to clinical studies during the COVID-19 PHE. An agenda for the meeting can be viewed here.

The meeting fulfills a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) and will discuss potential strategies for advanced planning to mitigate clinical study disruptions in the future.

The free two-day virtual public meeting will be held on Oct. 18 and 19 from 10 a.m. – 1:30 p.m. ET on both days.