On Tuesday, March 8th, BIO submitted comments in response to the recent Food and Drug Administration (FDA) guidance on the applicability of FDA's investigational new drug application (IND) regulations to various clinical study designs that utilize real-world data (RWD), and clarifies the Agency's expectations regarding clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness or safety of a drug (e.g., as part of a new drug application or a biologics license application) that are not subject to the IND regulations. In the comments submitted, BIO commended the FDA for making public how it is starting to organize the review of “various clinical study designs that utilize RWD submitted to the FDA in support of regulatory decision-making regarding the effectiveness and safety of a drug...” Additionally, BIO noted that though the Agency’s existing regulations on RWD/E provide a foundation on which to build the use of RWD, they will require collaborative efforts with researchers, data vendors, data scientists, bioinformaticists, and policy makers (ONC CMS) to accommodate the impact of the growing number of digital data sources used as RWD in non-interventional (and even interventional) studies. Therefore, BIO urged the Agency to work with the broad range of stakeholders who are part of the RWD generation ecosystem in order to provide clear guidance on how researchers can both collect and leverage RWD that is fit-for-purpose in regulatory decision-making. In addition to a number of specific line edits, BIO also suggested the FDA consider expanding the scope of the guidance to include recommendations regarding interventional studies (as well as observational studies) and to address the common scenario where a U.S.-based sponsor must work with a third party located outside of the United States to access RWD. Lastly, BIO indicated support for the FDA’s recommendations around early and often sponsor-agency engagement when use…