Food & Drug Law

Eli Y. Adashi, Katina M. Robison & I. Glenn Cohen, Deadly Legacy-The 510(k) Path toMedical Device Clearance, 157 JAMA Surgery 185 (2021).

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

Patricia J. Zettler, Eli Y. Adashi & I. Glenn Cohen, A Divisive Ruling on Devices – Genus Medical Technologies v. FDA, 385 New England J.

Eli Y. Adashi & I. Glenn Cohen, When Failure Is Not an Option: The Independent Panel Pandemic Report, Am. J. Med. (2021).

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.

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,…

Sara Gerke, Timo Minssen, Helen Yu & I. Glenn Cohen, Ethical and Legal Issues of Ingestible Electronic Sensors, 2 Nature Electronics 329 (2019).

I. Glenn Cohen & Nicholas Bagley, Private Rights and the Public Interest in Drug and Medical Device Litigation, 180 JAMA Internal Med. 299 (2019).

Eli Y. Adashi, Rohit S. Rajan & I. Glenn Cohen, When Science and Politics Collide: Enhancing the FDA, 364 Science 628 (2019).

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, Response to Open Peer Commentaries on “The Ethics of Smart Pills and Self-Acting…

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…

Spencer Phillips Hey, I. Glenn Cohen, Eli Y. Adashi & Aaron S. Kesselheim, Influence, Integrity, and the FDA: An Ethical Framework, 357 Science 876 (2017).

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

I. Glenn Cohen & Eli Y. Adashi, The FDA is Prohibited From Going Germline, 353 Science 545 (2016).

Michelle M. Mello & I. Glenn Cohen, Clinical Trials and the Right to Remain Silent, 174 JAMA Internal Med. 1505 (2014).

I. Glenn Cohen, Jeremy Feigenbaum & Eli Y. Adashi, Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men, 312…

Michael A. Carrier & Rebecca Tushnet, An Antitrust Framework for False Advertising, 106 Iowa L. Rev. 1841 (2021).

Eric Goldman & Rebecca Tushnet, 2 Advertising & Marketing Law Cases & Materials(4th ed. 2019).

Rebecca Tushnet, COOL Story: Country of Origin Labeling and the First Amendment, 70 Food & Drug L.J. 25 (2015).

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