FDA Arthritis Drugs Advisory Committee
Executive Summary
Will discuss "NDA Day" procedures and objectives and the role of the committee in the review of Rx Jan. 27-28 meeting. In June, the arthritis committee participated in the review of Syntex/Procter & Gamble's naproxen sodium OTC switch application and recommended against approval. A review of Greenwich Pharmaceuticals Therafectin, which was rejected by FDA in November, is set for Jan. 27. The meeting takes place in conference rooms D&E of FDA's Parklawn building beginning at 8:30 a.m. each day