Dr. Haider Warraich served as a Senior Advisor for Chronic Diseases to the FDA Commissioner at the U.S. Food and Drug Administration (FDA) from 2023 to 2024. In this role, he collaborated across FDA’s centers to develop programs, partnerships, strategies, and communications outlining the agency’s approach to drugs, devices, tobacco, nutrition, digital health, and artificial intelligence, particularly in the context of chronic disease. Selected works from his tenure are presented here.
PUBLICATIONS
Addressing the Challenge of Common Chronic Diseases
In this paper in the New England Journal of Medicine, we presented FDA’s broad strategy affecting common chronic conditions, ranging from drugs, devices, nutrition, and tobacco, to digital health and artificial intelligence.
FDA Perspective on the Regulation of AI in Healthcare and Biomedicine
This Special Communication in the Journal of the American Medical Association represents the most wide-ranging communication pertaining to FDA’s regulation of AI in healthcare and biomedicine, addressing concepts from Generative AI to AI in drug discovery and clinical research.
Digital Health Technologies for Cardiometabolic Disease and Diabetes
Digital health technologies offer significant promise for managing chronic diseases but have yet to fully realize their potential. In this perspective, the FDA outlines its position on how manufacturers can develop successful models that deliver meaningful outcomes for all stakeholders.
FDA and the Cardiovascular Community
This paper highlights the FDA’s extensive involvement in advancements related to cardiovascular disease and serves as a blueprint for how clinical communities can effectively engage with the agency. By detailing the FDA’s role in regulatory science, innovation, and policy development, the paper provides valuable insights into how healthcare professionals, researchers, and industry stakeholders can collaborate with the FDA to drive progress and enhance health outcomes for the public.
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Giving Cardiovascular Clinicians a Voice in Evidence Generation
A Collaboration Between the FDA and JACC, Journal of the American College of Cardiology. Clinicians play a critical role in research yet their voice is often not represented in discussions that set research priorities and agendas. At FDA, we launched a partnership with JACC to have clinicians share research questions of great clinical importance that need to be prioritized to advance patient care.
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Opportunities for Innovation in Smoking Cessation Therapies
A Perspective from the NIH and US FDA, Annals of Internal Medicine. To develop new innovative pathways for smoking cessation therapeutics, FDA and NIH worked together to develop a roadmap highlighting novel new opportunities to develop products helping Americans quit smoking.
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US FDA Updates in Nutrition Labeling
FDA has numerous initiatives to reduce diet related chronic disease that were highlighted in this work published in Annals of Internal Medicine, focused on innovation in nutrition labeling.
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