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Medical Research › Regulatory Requirements › New Guidance

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Knobbe Martens on

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

McDermott Will & Schulte

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

McDermott Will & Schulte on

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Hogan Lovells

FDA details recommendations for live case presentations during medical device clinical trials in final guidance

Hogan Lovells on

This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more

Hogan Lovells

NIH issues long-awaited guidance on other support, foreign components, and financial conflicts of interest

Hogan Lovells on

On 10 July 2019 the National Institutes of Health (NIH) issued its long-awaited guidance addressing grantee disclosure obligations related to researchers' activities outside the United States. ...more

Bricker Graydon LLP

FDA issues guidance on use of EHR data in clinical research

Bricker Graydon LLP on

Many hospitals and health systems conduct sponsored clinical research at their facilities, and clinical trial agreements typically require that sponsors and clinical investigators have access to certain data regarding the...more

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