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Knobbe Martens

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

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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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....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

Epstein Becker & Green

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

Epstein Becker & Green on

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July...more

BakerHostetler

FDA Issues Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

BakerHostetler on

On Aug. 15, the Food and Drug Administration (FDA) issued new guidance aimed at assisting institutional review boards (IRBs), clinical investigators and sponsors in complying with the FDA’s informed consent requirements for...more

Butler Snow LLP

UPDATE: NIH Provides Grant Guidance Considering COVID-19 Impact on Research

Butler Snow LLP on

Recognizing the impact that COVID-19 can have on research and the NIH grant application process, the NIH has issued 5 pieces of guidance between March 9 and 16, 2020 addressing various impacts of COVID-19 on NIH research...more

Butler Snow LLP

NIH Provides Grant Guidance Considering COVID-19 Impact on Research

Butler Snow LLP on

Recognizing the impact that COVID-19 can have on research and the NIH grant application process, the NIH has issued 5 pieces of guidance between March 9 and 16, 2020 addressing various impacts of COVID-19 on NIH research...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

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Verrill on

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...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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