Off-Label Prescribing

Abstract

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US Food and Drug Administration. “Off-label” and investigational use of marketed drugs, biologics, and medical devices—Information sheet. http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm. Updated June 25, 2015. Accessed June 27, 2015.

Neville

Frattarelli

Galinkin

. Off-label use of drugs in children. Pediatrics. 2014;133:563-567.

Goločorbin-Kon

Iličković

Mikov

. Reasons for and frequency of off-label drug use. Med Pregl. 2015;68:35-40.

Henry

. Off-label prescribing. Legal implications. J Leg Med. 1999;20:365-383.

Ansani

Branch

Fedutes-Henderson

. United States medical practice summary: innovative off-label medication use. Am J Med Qual. 2006;21:246-254.

Jones

Podolsky

. The history and fate of the gold standard. Lancet. 2015;385:1502-1503.

Rothwell

. External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet. 2005;365:82-93.

Schork

. Personalized medicine: time for one-person trials. Nature. 2015;520:609-611.

Dwan

Gamble

Williamson

Kirkham

. Systematic review of the empirical evidence of study publication bias and outcome reporting bias—an updated review. PLoS One. 2013;8:e66844.

10.

Rodwin

Abramson

. Clinical trial data as a public good. JAMA. 2012;308:871-872.