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.
NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: May 14, 0800/1200
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Peter Hudson, 240-276-3737
The committee will discuss, make recommendations and vote on a premarket approval application for Tyco Healthcare subsidiary Confluent Surgical Inc's DuraSeal XactTM Sealant System, which aims to be used as an adjunct to sutured dural repair to obtain watertight closure during spinal surgery. Tyco Healthcare is a part of Tyco International Ltd (TYC.N)
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
DATE: May 14-15, 0800/1200
LOCATION: Hilton Hotel, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Gail Dapolito,301-827-0314
On May 14, the committee will discuss the potential for Chlamydia trachomatis and Neisseria gonorrhea transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are recovered from the reproductive system or gestational tissues (e.g., amnionic membrane and placenta, cells recovered from menstrual blood, foreskin, placental/umbilical cord blood derived cell products), or other sources. In the afternoon, the committee will discuss animal models for porcine xenotransplantation products intended to treat Type 1 diabetes or acute liver failure.
On May 15, the committee will receive an update on guidance documents from the Office of Cellular, Tissue and Gene Therapies and the Center for Veterinary Medicine, and will discuss clinical issues related to the FDA draft guidance Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage.
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.
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
DATE: May 20, 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 GlaxoSmithKline Plc (GSK.L) for Rezonic tablets in combination with other antiemetic agents for the proposed indications of prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy (HEC), prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC), and prevention of postoperative nausea and vomiting (PONV).
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.
