Federal Register Notice: FDA’s Gastrointestinal Drugs Advisory Committee will meet 6/25-26, from 8:30 a.m. to 5 p.m. at the Marriott Washingtonian Center, Gaithersburg, MD. On 6/25, the committee will discuss Serono’s NDA for Serostim (somatropin for the treatment of short bowel syndrome in patients receiving specialized nutritional support. Serostim therapy should be used in conjunction with optimal management of short bowel syndrome. On 6/26, the committee will discuss an NDA for Photofrin (porfirmer sodium), Axcan Scandipharm, Inc. Photodynamic therapy with Photofrin is indicated for the ablation of high-grade dysplasia in Barrett's esophagus among patients who refuse esophagectomy and who are in overall good health. Contact Thomas H. Perez, (301) 827-6758. To view this notice, click here.
