Food and Drug Administration NPRM Webinar Series

On Sept. 28, 2022, the Food and Drug Administration (FDA) published two notices of proposed rule-making (NPRMs) in the Federal Register. The NPRM titled Protection of Human Subjects and Institutional Review Boards proposes changes to the FDA human subject regulations to simplify and harmonize the FDA’s regulations with the revised Department of Health and Human Services (HHS) Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act). The NPRM titled Institutional Review Boards; Cooperative Research proposes to replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the United States participating in FDA-regulated cooperative research to rely on the review and approval by a single IRB for that portion of the research that is conducted in the United States, with some exceptions.

The FDA has extended the comment period until Dec. 28, 2022, 11:59 p.m. Eastern time. After the FDA’s review of comments to the NPRMs, final rules may be published that would include any changes to the federal regulations. The FDA is proposing that the effective date of the Protection of Human Subjects and Institutional Review Boards final rule would be 180 days from the date of publication of the final rule. The FDA is proposing that the effective date of the Institutional Review Boards; Cooperative Research Final Rule would be one year from the date of publication of the final rule.

Huron presented two webinars, one for each NPRM, which provided summaries of the key portions of the NPRMs and provided an opportunity for audience questions, feedback, and discussion. If you would like additional insight into the NPRMs, or assistance identifying the most effective ways to help prepare your organization, please contact: