Food & Drug Law

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.

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

Kathryn Garfield, Erika Hanson, Carmel Shachar et al., States’ Use Of Medicaid Managed Care ‘In Lieu Of Services’ Authority To Address Poor Nutrition, 44 Health…

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).

Georgia R. Goodman et al., “I’d feel like someone was watchin’ me… watching for a good reason”: Perceptions of data privacy, access, and sharing in…

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. &…

Daniel G. Aaron, Michael S. Sinha & I. Glenn Cohen, The FDA’s Leucovorin Approval—A Departure From Evidentiary Standards, JAMA (2025).

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).

Carmel Shachar, Tess Wise, Gali Katznelson, et al., Criminal Justice or Public Health: A Comparison of the Representation of the Crack Cocaine and Opioid Epidemics…

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

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

Soumitri Barua, Robert Greenwald, Jason Grebely, Gregory J. Dore, Tracy Swan & Lynn E. Taylor, Restrictions for Medicaid Reimbursement of Sofosbuvir for the Treatment of…