Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Laurie Muldowney, MD
Deputy Director
Office of Scientific Investigations (OSI)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Dr. Laurie Muldowney serves as the Deputy Director of the Office of Scientific Investigations (OSI) in the Center for Drug
Evaluation and Research (CDER) at the U.S. Food and Drug Administration. In this role, she works collaboratively with the
Office Director to manage the development and implementation of patient focused, risk-based inspection, compliance,
and enforcement activities under the Agency Bioresearch Monitoring Program.
Dr. Muldowney joined the FDA/CDER in 2009 as a medical officer and has served in multiple positions across CDER,
including clinical team leader with the Division of Gastroenterology and Inborn Errors Products in the Office of New
Drugs and associate director for medical policy in the Office of Translational Science. Dr. Muldowney received a B.S. in
chemistry from the College of William and Mary and earned her medical doctorate from Jefferson Medical College in
Philadelphia, PA. Following additional postgraduate training, Dr. Muldowney served as a primary care physician with the
United States Navy and worked in medical communications.
Abstract
This presentation by Laurie Muldowney from FDA CDER’s Office of Scientific Investigations details the ClinicalTrials.gov requirements for applicable clinical trials (ACTs) involving drug products, highlighting the importance of transparency for innovation, patient and provider access to information, honoring subject participation, and enhancing public trust. The presentation outlines the distinct roles of the National Library of Medicine (NLM), the FDA, and the responsible party (RP), typically the study sponsor, in ensuring compliance. Key requirements covered include registration of ACTs within 21 calendar days of enrolling the first subject and reporting of results no later than one year after the primary completion date, with specific provisions for delayed submission under certain circumstances. Regular updates to the trial record are also mandatory. The FDA enforces these requirements through inspections, complaint evaluations, and surveillance, prioritizing cases based on potential risk and public health impact. Consequences for non-compliance begin with a preliminary notice, followed by a notice of non-compliance, and potentially civil money penalties, though voluntary compliance after the initial notices is common.