12/23/2024
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On November 6th, 2024, the International Council of Harmonization (ICH) published the draft version of ICH E6(R3) Annex 2, a long awaited update to the good clinical practice (GCP) section of the ICH Harmonized Guidelines.
Real-World Data and Evidence Generation with Dr. Hilary Marston
10/01/2024
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“Q&A with FDA” is the US Food and Drug Administration’s (FDA) podcast that began in 2022 which answers frequently asked questions by interviewing FDA staff members. The most recent episode was released on August 16th, 2024 titled “Real-World Data and Evidence Generation with Dr. Hilary Marston” hosted by Dr. Sara Roach interviewing Dr. Marston, the FDA’s Chief Medical Officer.
New Guidance for Industry on The Use of Real-World Evidence and Electronic Health Records in Regulatory Decision-Making
08/02/2024
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On July 25, 2024 the US Food and Drug Agency (FDA) published a final guidance for industry “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” This guidance is intended to help sponsors and other interested parties determine whether or not to use electronic health records (EHR) or medical claims data (information submitted to insurers to receive payments for treatments and other interventions) when making regulatory decisions on the effectiveness or safety of a drug.
Comment Now! Draft Guidance: Using RWE to Support Clinical Trials and Observational Studies
12/14/2021
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The US Food and Drug Administration (FDA) released a draft guidance “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products” for public comment in December 2021. This draft guidance is published as part of a series of real-world evidence (RWE) guidance in line with the 21st Century Cures Act (Cures Act). Part of the Cures Act is related to the use of real-world evidence (RWE) to help support regulatory decision making, including the approval of a new indication for an approved drug or to support post approval study requirements. This draft guidance discusses its applicability in using RWE in clinical trials and observational studies.
Comment Now! Another RWE Draft Guidance: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
12/07/2021
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The US Food and Drug Administration (FDA) released a draft guidance “Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products” for public comment in November 2021. This draft guidance is published in line with the 21st Century Cures Act (Cures Act). A good source of RWE, a registry is an “organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or exposure.”