Nov 30 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.”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. This guidance provides sponsors and other stakeholders with considerations when either proposing to design a registry or using an existing registry to support regulatory decision-making about a drug's effectiveness or safety.
Submit either electronic or written comments on the draft guidance by February 28, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
FDA is announcing the availability of a draft guidance for industry entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.” FDA is issuing this guidance as part of its RWE Program and to satisfy, in part, the mandate under section 505F of the FD&C Act (21 U.S.C. 355g) to issue guidance about the use of RWE in regulatory decision-making. Topics covered in this guidance include:
• A registry's fitness-for-use for regulatory decision-making, focusing on attributes of a registry that support the collection of relevant and reliable data
• Considerations when linking a registry to another data source, such as data from medical claims, electronic health records, digital health technologies, or another registry
• Considerations for supporting FDA review of submissions, including registry data
Section 3022 of the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) amended the FD&C Act to add section 505F, Utilizing Real World Evidence. 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 committed to publishing draft guidance on how RWE can contribute to the assessment of safety and effectiveness in regulatory submissions. FDA is issuing this draft guidance as part of a series of guidance documents to satisfy the Cures Act mandate and the PDUFA VI commitment.
Draft guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products
FR notice inviting comment: https://www.federalregister.gov/documents/2021/11/30/2021-26006/real-world-data-assessing-registries-to-support-regulatory-decision-making-for-drug-and-biological