Alexandra Maulden

Foley & Lardner LLP

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Latest Posts › Clinical Trials

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FDA & OHRP Draft Guidance: Including Tissue Biopsies in Clinical Trials

The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more

2/4/2025 / Clinical Trials , Department of Health and Human Services (HHS) , Draft Guidance , Ethics , Food and Drug Administration (FDA) , Life Sciences , Medical Research , Patient Safety , Regulatory Requirements , Risk Management

Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

7/26/2024 / Clinical Trials , Compliance , Consolidated Appropriations Act (CAA) , Department of Health and Human Services (HHS) , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Popular

Clinical Trials: Consent Process Clarified in New FDA Final Guidance

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more

9/11/2023 / Clinical Trials , Compensation , Consent , Department of Health and Human Services (HHS) , Final Guidance , Food and Drug Administration (FDA) , Institutional Review Board (IRB) , Investigations

FDA Publishes Framework for Digital Health Technologies in Clinical Trials

On March 23, the U.S. Food and Drug Administration (FDA) published a framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials. DHTs include a wide array of...more

4/4/2023 / CDRH , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Digital Health , Food and Drug Administration (FDA) , Medical Devices , PDUFA

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