U.S. Legislation & Regulation
Enabling clinical research by advancing U.S. legislation and regulation
ACRO supports a strong, robust FDA with expanded resources to ensure better control over the quality, safety, and efficacy of clinical trials and drug development in the United States.
ACRO’s US agenda is focused on promoting policies that foster innovation. ACRO engages with – and provides industry expertise to – the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the U.S. Congress, and other government bodies.
Contact us for more information about our US advocacy.
ACRO’s US Regulatory & Legislative Comments
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Comment Letter
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
Comment Letter
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway
Comment Letter
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
Comment Letter