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Ropes & Gray LLP

Insights from the Third Annual Ropes & Gray Rare Disease Forum

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Ropes & Gray recently hosted its Third Annual Ropes & Gray Rare Disease Forum on May 1, 2025 in Cambridge, Massachusetts. The event gathered legal, commercial, and patient advocacy experts in the rare disease community to...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Guidance on Drug and Biologic Submissions with Real-World Data and Real-World Evidence

Wilson Sonsini Goodrich & Rosati on

Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more

McDermott Will & Schulte

FDA Issues Draft Guidance on the Use and Curation of Real-World Data in Registries

McDermott Will & Schulte on

The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support regulatory decision-making. Pharmaceutical...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Draft Guidance for Sponsors and Other Stakeholders on Using Registries as RWD to Support Regulatory Decision-Making

Faegre Drinker Biddle & Reath LLP on

The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for...more

Goodwin

Things for Pharma and Biotech Companies to Watch in the Cures 2.0 Proposed Legislation

Goodwin on

Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more

Faegre Drinker Biddle & Reath LLP

FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

Faegre Drinker Biddle & Reath LLP on

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q4 2020

Wilson Sonsini Goodrich & Rosati on

In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more

Hogan Lovells

The EMA has published guidance on registry-based studies as a tool to generate RWE

Hogan Lovells on

On 24 September 2020, the European Medicines Agency (“EMA”) published a draft Guideline on registry-based studies. The EMA’s intention is to enhance the use of registry-based studies as a source of real-world evidence (RWE)....more

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