Food & Drug Law

Mason Marks, Rebecca W. Brendel, Carmel Shachar et al., Essentials of Informed Consent to Psychedelic Medicine, 81 JAMA Psychiatry 611 (2024).

David M. Eisenberg, Alexis Cole, Edward J. Maile et al., Proposed Nutrition Competencies for Medical Students and Physician Trainees: A Consensus Statement, 7 JAMA Network…

Bethany Agusala, Emily Broad Leib & Jaclyn Albin, The Time is Ripe: The Case for Nutrition in Graduate Medical Education in the United States, 11…

Annabel Kupke, Carmel Shachar & Christopher Robertson, Pulse Oximeters and Violation of Federal Antidiscrimination Law, 329 JAMA 365 (2023).

James Salzman, Drinking Water: A History (2d ed. 2017).

Erika Hanson, Daniel Albert-Rozenberg, Kathryn M. Garfield et al., The Evolution and Scope of Medicaid Section 1115 Demonstrations to Address Nutrition: A U.S. Survey, 2…

Peter Grossi & Keri Arnold, Drug Product Liability at the Crossroads, in The Oxford Handbook of U.S. Health Law (I. Glenn Cohen, Allison K. Hoffman…

Peter Grossi & Daphne O’Connor, FDA preemption of conflicting state drug regulation and the looming battle over abortion medications, 10 J. L. Biosciences (2023).

Sara Gerke, Carmel Shachar, Peter R. Chai & I. Glenn Cohen, Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies During COVID-19, 26 Nature Med.

Mason Marks & I. Glenn Cohen, How Should the FDA Evaluate Psychedelic Medicine?, 389 New England J. Med. 1733 (2023).

Mason Marks & I. Glenn Cohen, Psychedelic Therapy: A Roadmap for Wider Acceptance and Utilization, 27 Nat. Med. 1669 (2021).

Cameron Faustman, Daniel Aaron, Nicole Negowetti & Emily Broad Leib, Ten Years Post-GAO Assessment, FDA Remains Uninformed of Potentially Harmful GRAS Substances in Foods, 61…

Jennifer L. Pomeranz, Sean B. Cash, Emily Broad Leib et al., Advancing The FDA’s Human Foods Program Through Additional Authorities And User Fees, 44 Health…

Sara Gerke, Boris Babic, Theodoros Evgeniou & I. Glenn Cohen, The Need For a System View to Regulate Artificial Intelligence/Machine Learning-Based Software as Medical Device,…

John H. Rex, Holly Fernandez Lynch, I. Glenn Cohen, Jonathan J. Darrow & Kevin Outterson, Designing Development Programs for Non-Traditional Antibacterial Agents, 10 Nature Comm.

Pieter A. Cohen & Emily M. Broad Leib, Ingesting Risk – The FDA and New Food Ingredients, 391 New England J. Med. 875 (2024).

Stephen Devries & Emily Broad Leib, Nutrition education in medical training: it’s always been a matter of trust, 120 Am. J. Clinical Nutrition 465 (2024).

Katharine Van Tassel, Carmel Shachar & Sharona Hoffman, Covid-19 Vaccine Injuries — Preventing Inequities in Compensation, New England J. Med. (2021).