FDA moves closer to new requirements for NTI drugs

Traynor, Kate
September 2011
American Journal of Health-System Pharmacy;9/1/2011, Vol. 68 Issue 17, p1568
Academic Journal
The article reports that the definition of narrow therapeutic index (NTI) drugs proposed by the FDA received near-unanimous support from the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology at a meeting held July 26, 2011 in Silver Spring, Maryland. The proposed definition requires NTI drugs to have steep dose-response curves for safety and efficacy. Included are comments from Lawrence Yu, deputy director for science and chemistry at FDA's Office of Generic Drugs.


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