U.S. FDA advisory meetings through June 30
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
DATE: May 19, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss the safety and efficacy of a new drug application from Debiovision Inc for Sanvar for the proposed indication as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension. Salix Pharmaceuticals (SLXP.O) holds U.S. marketing rights for Sanvar.
ANESTHESIOLOGY AND RESPIRATORY THERAPY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: May 28, 0800/1200
LOCATION: Holiday Inn, Two Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Neel Patel, 240-276-3700
The committee will discuss, make recommendations and vote on a premarket approval application for Ethicon Endo-Surgery Inc's Sedasystm Computer-Assisted Personalized Sedation System, a device for the intravenous administration of 1 percent propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation in adult patients undergoing colonoscopy and esophagogastroduodenoscopy procedures. Ethicon Endo-Surgery is a Johnson & Johnson (JNJ.N) company.
ONCOLOGIC DRUGS ADVISORY COMMITTEE
DATE: May 29, 0800/1200
LOCATION: Rosen Shingle Creek, 9939 Universal Blvd., Orlando, Fla.
CONTACT: Nicole Vesely, 301-827-6793 Continued...
