Food & Drug Law

Dennis W.Choi, Robert Armitage, Linda S. Brady, Timothy Coetzee, William Fisher, Steven Hyman, Atul Pande, Steven Paul, William Potter, Benjamin Roin & Todd Sherer, Medicines…

Jack Landman Goldsmith & Alan Sykes, The California Effect, Process-Based Regulations, and the Dormant Commerce Clause (Harv. Pub. L. Working Paper No. 22-35, Oct. 2,…

Holly Fernandez Lynch, Peter Lurie & I. Glenn Cohen, Checks and Balances on FDA’s Authority, JAMA (2024).

Aditya Narayan, I. Glenn Cohen & Eli Y. Adashi, Food and Drug Omnibus Reform Act: A Critical Course Correction, 99 Mayo Clinic Proc. 869 (2024).

Eli Y. Adashi, Daniel P. O’Mahony & I. Glenn Cohen, Paying for Over-the-Counter Contraception: The Opill Quandary, 3 Am. J. Med. 200 (2024).

Eli Y. Adashi, I. Glenn Cohen & Allen J. Wilcox, The FDA Declares Levonorgestrel a Nonabortifacient—A 50-Year Saga Takes a Decisive Turn, 8 JAMA Health…

Eli Y. Adashi, Daniel P. O’Mahony & I. Glenn Cohen, The Inflation Reduction Act: Recasting the Medicare Prescription Drug Plans, Am. J. Preventative Med. (2023).

Eli Y. Adashi & I. Glenn Cohen, The FDA Initiative to Assure Racial and Ethnic Diversity in Clinical Trials, 36 J. Am. Bd. Fam. Med.

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

Daniel G. Aaron, I. Glenn Cohen & Eli Y. Adashi, The FDA Struggle to Withdraw Makena, JAMA (2022).

Eli Y. Adashi & I. Glenn Cohen, Integrity of SARS-CoV-2 Laboratory-Developed Tests—Reply, 328 JAMA 478 (2022).

Winston McCormick, Eli Y. Adashi & I. Glenn Cohen, Expanding the Blood Pool: The Limitations of the FDA’S Current MSM Blood Deferral, 97 Mayo Clinic…

Eli Y. Adashi & I. Glenn Cohen, The CMS Vaccine Mandate at the Supreme Court: A Hippocratic Imperative, Am. J. Med. (2022).

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

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

Mason Marks & I. Glenn Cohen, Patents on Psychedelics: The Next Legal Battlefront of Drug Development, 135 Harv. L. Rev. F. (2022).

Kerry Lynn Macintosh, I. Glenn Cohen, Jacob. S. Sherkow & Eli Y. Adashi, Gene Editing Sperm and Eggs for Use in Clinical Trials – The…

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).

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…