2023-16544: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies; Public Meeting
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies." This public meeting will satisfy the mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) to convene a public meeting on clinical study flexibilities initiated in response to the COVID-19 pandemic. The public meeting will be convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative (CTTI) to bring the clinical research community together to discuss a variety of topics related to mitigating disruptions of clinical studies of medical products during disasters and public health emergencies (PHEs). The meeting format will include presentations and panel discussions.
The agency’s own summary, as published.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →