FDA's September 2022 NPRMs: What They Mean For Academia And Industry

By Julie Ozier, MHL, CIP, CHRC, Senior Vice President for IRB Review

On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed harmonization with the Health and Human Services (HHS) 2018 Common Rule (also referred to as the revised Common Rule). This blog highlights some of the major proposed changes and how they may impact the clinical research community.