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Panel to Discuss Bioequivalence, Phospholipidosis

03/11/2010

Federal Register Notice: FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will meet 4/14, from 8 a.m. to 5 p.m. at the Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The committee will (1) Hear presentations from the Office of Generic Drugs on a proposal for revision of the bioequivalence approaches to discuss adding a limitation on point estimates; (2) receive presentations on an awareness topic to highlight some issues associated with product instability; and (3) receive and discuss presentations from Office of Pharmaceutical Science on the regulatory challenges of drug-induced phospholipidosis. Contact Anuja Patel, (301) 827-7001. To view this notice, click here.

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