Dec 10 -- The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance of Industry,” published in the Federal Register on September 30, 2021. Submit either electronic or written comments by January 24, 2022.
https://www.federalregister.gov/documents/2021/12/10/2021-26699/real-world-data-assessing-electronic-health-records-and-medical-claims-data-to-support-regulatory
Sept 30 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” FDA is issuing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and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 This draft guidance is intended to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety.
This guidance discusses the following topics related to the potential use of EHRs and medical claims in clinical studies to support regulatory decisions: Selection of data sources that appropriately address the study question and sufficiently capture study populations, exposure, outcomes of interest, and key covariates; development and validation of definitions for study design elements ( e.g., exposure, outcomes, covariates); and data provenance and quality during data accrual, data curation, and data transformation into the final study-specific dataset.
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: (1) Help to 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 (2) help to support or satisfy postapproval study requirements. This section also requires that FDA use 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 the 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 the goal of publishing draft guidance on how RWE can contribute to the assessment of safety and effectiveness in regulatory submissions.
FDA is issuing the draft guidance as part of a series of guidance documents to satisfy the Cures Act mandate and the PDUFA VI goal. The RWE Program will cover clinical studies that use real-world data sources, such as information from routine clinical practice, to derive RWE.
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory
FR notice inviting comment:
https://www.federalregister.gov/documents/2021/09/30/2021-21315/real-world-data-assessing-electronic-health-records-and-medical-claims-data-to-support-regulatory