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

Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

Reps. DeGette and Bucshon Request for Information: Next Generation of Cures

Provisions Pertaining to Preventing Access to Americans’ Bulk Sensitive Personal Data and U.S. Government-Related Data by Countries of Concern

Enhancing Adoption of Innovative Clinical Trial Approaches

Conducting Remote Regulatory Assessments—Questions and Answers; Revised Draft Guidance for Industry