In Effort to Avoid Supply Chain Disruptions, FDA Extends DSCSA Exemptions

FDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop the first intergovernmental health artificial intelligence (AI) lab. This lab would test health-related AI applications for safety and effectiveness in a virtual lab environment. VA Undersecretary for Health Dr. Shereef Elnahal announced the news during the Veterans Health Administration Innovation Experience conference. The VA serves 9 million veterans—the largest health system in the country. The VA operates 170 medical centers nationwide, meaning that the VA could be well positioned to serve as a base for AI assurance labs across the country.

Roughly one out of every ten people in the United States are affected by rare diseases. Many of these conditions are life‑threatening, and most lack FDA-approved treatments. Developing therapies for rare diseases, however, is challenging for various reasons, including the complex biology involved, the limited understanding of disease progression (i.e., the natural history), and the difficulties of conducting clinical trials in small patient populations. FDA engages with many stakeholders in the rare disease community to inform the development of safe and effective therapies and has made, in recent months, major strides in amplifying these efforts.

FDA’s Center for Devices and Radiological Health (CDRH) recently announced a pilot program to provide consumers and health care professionals with key information about clinical trials that supported the FDA’s approval of new medical devices. This program is modeled after the Center for Drug Evaluation and Research (CDER) drug trials snapshots program. The snapshots address questions about who participated in clinical studies of new medical technology and what clinical trial information is available about how it works in different groups of people. Snapshots are currently available for approvals of higher risk devices approved under original premarket approval (PMA) applications from April to July 2024. The snapshots only provide information that was available at the time of approval, and the FDA does not plan to update them over time, with real-world data, for example.

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research and changing organizational culture. Dr. Tarver has held various leadership positions while at the FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation, and the Program Director of Patient Science and Engagement. Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the health care ecosystem and stimulate creative evidence generation pathways.

On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests detecting the flu and COVID-19 exist, they are authorized only for emergency use. The Healgen test is the first combination test authorized to be marketed outside of emergency use. This authorization is consistent with FDA’s continued commitment to supporting the development and availability of at-home tests.

On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here.¹   FDA intends the glossary to be used for general education purposes. The definitions are either directly from, or adapted from, various public sources, including consensus standard organizations and published literature, and FDA includes references to those sources in the glossary.

On October 9, the FDA announced that the agency is providing exemptions from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for eligible trading partners, which were scheduled to take effect on November 27. This exemption applies to drug products transacted by trading partners that have successfully completed (or made documented efforts to complete) data connections with their immediate trading partners, but still face challenges exchanging data.

On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use.