Food & Drug Law

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…

Eli Y. Adashi & I. Glenn Cohen, Medical Aid in Dying State Laws: A Thirty Year Evolution, 38 The Journal of the American Board of…

Eli Y. Adashi, Daniel P. O’Mahony & I. Glenn Cohen, National Drug Shortages: Remedial Executive and Legislative Initiatives, 38 The Journal of the American Board…

Mason Marks & Carmel Shachar, Drug scheduling limits access to essential medicines and should be reformed, 29 Nature Med. 294 (2023).

Eli Y. Adashi, Daniel P. O’Mahony & I. Glenn Cohen, The Right to Contraception Act: A Present-Day Imperative, 34 J. Women’s Health 164 (2025).

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

Mason Marks, I. Glenn Cohen, Jonathan Perez- Reyzin et al., Microdosing Psychedelics Under Local, State, and Federal Law, 103 B.U. L. Rev. 101 (2023).

Luke Gelinas, Holly Fernandez Lynch, Barbara E. Bierer & I. Glenn Cohen, When Clinical Trials Compete: Prioritising Study Recruitment, 43 J. Med. Ethics 803 (2017).

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

Eli Y. Adashi, Daniel P. O’Mahony & I. Glenn Cohen, The FDA Modernization Act 2.0: Drug Testing in Animals is Rendered Optional, Am. J. Med.

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.

Akif Khan, Corinne Shanahan & Emily Broad Leib, Checking in on Food Labeling: A Summary of Key Themes from Responses to USDA-FSIS and FDA’s Joint…

Effy Vayena, Alessandro Blasimme & I. Glenn Cohen, Machine Learning in Medicine: Addressing Ethical Challenges, 15 PLoS Med. e1002689 (2018).

Craig M. Klugman, Laura B. Dunn, Jack Schwartz & I. Glenn Cohen, The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at…

Nathan G. Cortez, I. Glenn Cohen & Aaron S. Kesselheim, FDA Regulation of Mobile Health Technologies, 370 New Eng. J. Med. 372 (2014).

Eli Y. Adashi et al., The next two decades of mifepristone at FDA: History as destiny, Contraception (2022).

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,…

Walker Morrell, Carmel Shachar & Anthony P. Weiss, The oversight of autonomous artificial intelligence: lessons from nurse practitioners as physician extenders, 9 J. L. &…

Jacob S. Sherkow, Eli Y. Adashi & I. Glenn Cohen, Assessing—and Extending—California’s Insulin Manufacturing Initiative, JAMA (2023).

Amy L. McGuire, Holly Fernandez Lynch, Lewis A. Grossman et al., Pressing Regulatory Challenges for Psychedelic Medicine, 380 Science 347 (2023).

Patricia J. Zettler, Eli Y. Adashi & I. Glenn Cohen, Alliance for Hippocratic Medicine v. FDA — Dobbs’s Collateral Consequences for Pharmaceutical Regulation, 388 New…