Legislation & Regulation

Legislation and Regulation in the U.S.

About half of clinical trials take place in the United States. That’s why ACRO works with US legislators and regulators to ensure a positive regulatory and business environment that supports high-quality, safe and ethical clinical research. ACRO’s US agenda is focused on promoting policies that foster innovation and ensure that the U.S. remains a competitive venue for clinical trials. ACRO engages with – and provides CRO expertise to – the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Office for Human Research Protections (OHRP) and the U.S. Congress.

Our current US legislative priorities

  • Engage with the FDA, the NIH and Congress on provisions of the 21st Century Cures Act that are important to our industry, including the use of real-world evidence (RWE), development of new review pathways, adaptive designs and novel statistical modeling, patient-centered development programs, clinical trial data sharing, and more.
  • Support regulatory acceptance of mobile device, EHR, patient-reported outcomes, and other data in clinical trials, and the use of analytical tools to facilitate innovation and drive an integration of clinical research and clinical care.
  • Contribute regulatory comments on proposed guidances and rules that impact clinical research.
  • Advance tax policies that recognize the critical role that clinical research plays in R&D.
  • Read our full history of regulatory comments on proposed guidances and rules in the United States that would impact clinical research organizations.

ACRO and the FDA

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. Since ACRO’s founding in 2002, every FDA Commissioner has met with our Board of Directors, ensuring our efforts remain consistent with the Administration’s goals and objectives.

ACRO’s engagement with the FDA includes advocacy for increased appropriations, support of the agency’s goal of bolstering its regulatory science capabilities and collaborating with FDA officials on an array of regulatory issues important to clinical research.

What Else We’re Doing

In addition to supporting a strong FDA with extensive oversight, ACRO also works with the following organizations, government bodies, and initiatives in the United States:

Read more about ACRO’s legislative and regulatory policy goals: