Docket ID FDA-2021-D-1214-0001 is open for public comment
Bethesda, MD - The Food and Drug Administration (FDA) has announced the availability of draft guidance for intervention industry stakeholders entitled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” The FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program and to fulfill the mandate created by the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making.
The FDA has created a framework to evaluate the potential use of RWE to help support the approval of a new indication for a drug already approved under the FD&C Act or to help to support or satisfy post-approval study requirements.
The guidance discusses the applicability of the 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.
MTPPI has submitted its comments on the draft guidance to the FDA. Those comments can be accessed here.
To learn more about MTPPI's Real-World Evidence research practice, contact info@mtppi.org