U.S. Legislation and Regulation
Enabling Clinical Research by Advancing US Legislation and Regulation
Enabling Clinical Research by Advancing US Legislation and Regulation
Half of all 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.
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.
In addition to supporting a strong FDA with extensive oversight, ACRO also works with The Office for Human Research Protections, The National Institutes of Health (NIH) and other organizations, government bodies, and initiatives in the United States.
Read ACRO’s full history of regulatory comments on proposed guidances and rules in the United States that would impact clinical research and technology organizations.
United States Regulatory Comments
As part of its advocacy program in the US, ACRO submits regulatory comments to US regulators – such as the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). ACRO’s US regulatory comments are listed below.
Contact us for more information about our US advocacy.
2023
FDA
NIH NCATS
2022
FDA
FTC
2021
FDA
2020
CDC
2019
FDA
HHS and OCR
IRS
2018
FDA
2017
FDA
2016
FDA
2015
FDA
NIH
OHRP
2014
FDA