Food & Drug Law

David A. Simon, Carmel Shachar & I. Glenn Cohen, At-home Diagnostics and Diagnostic Excellence: Devices vs General Wellness Products, 327 JAMA 523 (2022).

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).

Jacob E. Gersen & Benjamin Sachs, Protect Those Who Protect Our Food, N.Y. Times, Nov. 13, 2014, at A33.

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…

James René Jolin, Carmel Shachar & Eli Y. Adashi, Future Directions For Delivering Contraceptive Healthcare Services Via Telehealth, Health Aff. Forefront (2023).

Sara Gerke, Gali Katznelson, Dorit Reiss, et al., COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations, 49 J. L. Med. &…

Robert Böhm, Cornelia Betsch, Yana Litovsky et al., Crowdsourcing interventions to promote uptake of COVID-19 booster vaccines, 53 eClinicalMedicine (2022).

Brian Wolfman & Anne King, Mutual Pharmaceutical Co. v. Bartlett and Its Implications, 82 U.S.L.W., no. 17, at 1 (Nov. 5, 2013).

Daniel G. Aaron, Eli Y. Adashi & I. Glenn Cohen, The US FDA’s New Rule for Regulating Laboratory-Developed Tests, 5 JAMA Health F. (2024).