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.

U.S. Legislation & Regulation

ACRO’s US Regulatory & Legislative Comments

Enhancing Adoption of Innovative Clinical Trial Approaches

Conducting Remote Regulatory Assessments—Questions and Answers; Revised Draft Guidance for Industry

Postmarketing Approaches to Obtain Data on Underrepresented Populations

Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry

NCATS RFI: Advancing Clinical and Translational Science through Accelerating the Decentralization of Clinical Trials

Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Q&A for Industry