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Dec 9 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. FDA 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 postapproval study requirements. This guidance discusses 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.
 
Submit comments on the draft guidance by March 9, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
 
FDA is announcing the availability of a draft guidance for industry entitled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” The draft guidance discusses the following major topics: (1) Applicability of part 312 (21 CFR part 312) to studies using RWD and (2) regulatory considerations for non-interventional (observational) studies using RWD. Topics covered under regulatory considerations include the following: (1) Transparency for data collection and analysis, (2) data access, (3) study monitoring, (4) safety reporting, and (5) sponsor responsibilities.
 
Section 3022 of the 21st Century Cures Act (Cures Act) amended the FD&C Act to add section 505F, Utilizing Real World Evidence (21 U.S.C. 355g). This section requires the establishment of a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) and to help support or satisfy postapproval study requirements. This section also requires that FDA utilize the program to inform guidance for industry on the circumstances under which sponsors of drugs may rely on RWE and the appropriate standards and methodologies for collection and analysis of RWE submitted to evaluate the potential use of RWE for those purposes. Further, under the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), FDA is committed to publishing draft guidance on how RWE can contribute to the assessment of safety and effectiveness in regulatory submissions. FDA is issuing the draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products” as part of a series of guidance documents to satisfy the Cures Act mandate and the PDUFA VI commitment.

Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug
FR notice inviting comment: https://www.federalregister.gov/documents/2021/12/09/2021-26640/considerations-for-the-use-of-real-world-data-and-real-world-evidence-to-support-regulatory

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