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Panel to Discuss Bioequivalence Issues, NTI Drug Products

Federal Register Notice: FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will meet 7/26, from 8 a.m. to 5:30 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee will discuss presentations by the Office of Generic Drugs on bioequivalence issues and quality standards relative to narrow therapeutic index (NTI) drug products as a class. In response to feedback during a 4/13/10 panel meeting, the committee will discuss the definition and list of NTI drugs, and proposed bioequivalence standards for these products. To view this notice, click here.

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