References
- Department of Health and Human Services. Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for information regarding drugs potentially generally recognized as safe and effective. 85 Fed Reg. 2020 Nov 25;75,331. .
- Gupta R, Dhruva SS, Fox ER, et al. The FDA Unapproved Drugs Initiative: An observational study of the consequences for drug prices and shortages in the United States. J Manag Care Spec Pharm. 2017 Oct;23(10):1066–1076.
- Staff. FDA enforcement against injectable colchicine. The Rheumatologist. 2008 May 1.
- Quinn R. Generic colchicine approved for gout prophylaxis. The Rheumatologist. 2015 Mar 1.
- Frequently asked questions regarding the Department of Health and Human Services’ announcement on the Unapproved Drugs Initiative. Department of Health and Human Services.
- Vizient. Vizient analysis shows ending Unapproved Drugs Initiative could save between $7.52 billion and $26.59 billion. 2020 Nov 23.
- Carico RL, Emmendorfer TR, Aspinall SL, et al. Review of purchases of unapproved medications by the Veterans Health Administration. Am J Health Syst Pharm. 2019 Nov 13;76(23):1934–1943.
