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FDA RWD/RWE regulatory considerations in draft guidance highlight opportunities and challenges - Laying groundwork for high-quality evidence to support regulatory decisions | Hogan Lovells

This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs...
United States Robert Califf Stephen Hahn Hogan Lovells Scott Gottlieb Commissioners Stephen Hahn

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials | Bass, Berry & Sims PLC

On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled...
United States Human Service Department Of Health Advisory Committee On Human Research Protections Risk Considerations When Using Digital Health Technologies Drug Administration

Research Roundup: FDA Uses Fall And Winter 2021 To Release Significant New Guidance Governing Hot-Button Life Sciences Research Topics - Food, Drugs, Healthcare, Life Sciences

This Advisory provides an update on several recently issued US Food and Drug Administration (FDA or the Agency) draft guidance documents and advice addressing areas of increased attention.
United States Sam Williams University Of Michigan Law School Laboratory Improvement Amendments Device Manufacturer Communications Communications Consistent
Source: mondaq.com

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FDA Issues Draft Guidance on the Use and Curation of Real-World Data in Registries | McDermott Will & Emery

The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support...
Product Development To Support Labeling Drug Administration Mcdermott Will Real World Data Assessing Registries Support Regulatory Decision Making

FDA Regulatory-Rulemaking from Real-World Data from Registries

Food and Drug Administration draft guidance outlining recommendations for using real-world data from registries to support regulatory decision-making. Pharmaceutical manufacturers and other life-sciences industry stakeholders should review guidance & submit comments by February 28, 2022
Product Development To Support Labeling Drug Administration Real World Data Assessing Registries Support Regulatory Decision Making Biological Products Guidance

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