Journal Articles

Klara, K, Kim, J, Ross JS (2018) Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. J Gen Intern Med 2018 Feb. 26. [Epub ahead of print]

Wallach JD, Ross JS. Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Evaluation Efforts. JAMA. 2018;319(8):776–778.

Egilman AC, Wallach JD, Ross JS, Dhruva SS. Medicare Spending and Potential Savings on Brand-Name Drugs With Available Generic Substitutes Excluded by 2 Large Pharmacy Benefit Managers, 2012 Through 2015. JAMA Intern Med. 2018 Jan. 16. [Epub ahead of print]

Kapczynski A, Kim J. Clinical Trial Transparency: The FDA Should and Can Do More. The Journal of Law, Medicine & Ethics. 2018;45(2_suppl):33-38.

Sharfstein JM, Miller JD, Davis AL, Ross, JS, McCarthy ME, Smith B, Chaudry A, Alexander GC, Kesselheim AS. Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products. The Journal of Law, Medicine & Ethics 2018;45(2_suppl):7-23.

Wallach JD, Egilman AC, Gopal AD, Swami N, Krumholz H, Ross JS. Biomedical Journal Speed and Efficiency: A Cross-sectional Pilot Survey of Author Experiences. Research Integrity and Peer Review. 2018;3(1).

Wallach JD, Gonsalves GS, Ross JS. Research, regulatory, and clinical decision-making: the importance of scientific integrity. J Clin Epidemiol. 2018;93:88-93.

Kim J, Kapczynski A. Promotion of Drugs for Off-label Uses: The US Food and Drug Administration at a Crossroads. JAMA Intern Med. 2017;177(2):157-158.

Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS. JAMA. 2017;319(1):21-22.

Krumholz HM, Kim J. Data Escrow and Clinical Trial Transparency. Ann Intern Med. 2017;166(12):893-894. Policy Papers

McCarthy ME, Kim J, Ross JS, eds. Promoting Transparency in Clinical Research Why and How. New Haven, CT: Yale Collaboration on Research Integrity and Transparency; November 2017.

McCarthy ME, Gonsalves GS, eds. What’s in Your Medicine Cabinet? Ensuring the Safety and Efficacy of Prescription Drugs, Biologics and Medical Devices in the United States. New Haven, CT: Yale Collaboration on Research Integrity and Transparency; 3rd Edition, February 2018. This paper is also available in Spanish, French, and Portuguese.