Wednesday May 6, 04:54 PM
CORRECTED-U.S. FDA advisory meetings through June 30
(Corrects first item to show Confluent Surgical is owned by Covidien, not Tyco Healthcare, as originally sent)
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 Confluent Surgical Inc's DuraSeal Xact Sealant System, which aims to be used as an adjunct to sutured dural repair to obtain watertight closure during spinal surgery. Covidien Ltd owns Confluent Surgical.
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Tissue and Gene Therapies and the Center for Veterinary Medicine, and will discuss clinical issues related to the FDA draft guidance Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage.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 (NASDAQ: SLXP - news) 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 (LSE: GSK.L - news) 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 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
The committee will discuss an a biologics license application from GlaxoSmithKline Plc for Arzerra, known generically as ofatumumab, for the proposed indication of treatment of patients with chronic lymphocytic leukemia who have received prior therapy. The drug is being developed with Genmab A/S (Copenhagen: GEN.CO - news) .
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: June 2, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Janie Kim, 301-827-7001
The committee will discuss new drug application from Advanced Life Sciences (ADLS - news) for cethromycin oral tablets for the proposed indication of outpatient treatment of adults with mild to moderate community-acquired pneumonia.
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: June 3, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Janie Kim, 301-827-7001
The committee will discuss issues related to the development of drugs for the treatment of tuberculosis, including drug resistant tuberculosis. Areas of discussion include diagnosis, treatment duration, study design (such as endpoints and duration of follow-up) and safety issues.
Keywords: FDA ADVISORY/DIARY
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
DATE: June 9-10, 0800/1200
LOCATION: Marriott Conference Centers, UMUC Inn and Conference Center, 3501 University Blvd. East, Adelphi, MD.
CONTACT: Diem-Kieu Ngo, 301-827-7001
On both days, the committee will discuss the following drugs and vote on whether they have been shown to be effective and acceptably safe for children and teenagers:
* AstraZeneca PLC's Seroquel, or quetiapine fumarate, for the acute treatment of schizophrenia in patients 13 to 17 years old, and the acute treatment of bipolar mania in those ages 10 to 17.
* Pfizer Inc's Geodon, or ziprasidone hydrochloride, for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in patients 10 to 17 years old.
* Eli Lilly and Co's Zyprexa, or olanzapine, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents.
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE
DATE: June 12, 0800/1200
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
CONTACT: William Freas or Rosanna Harvey, 301-827-0314
The committee will review and discuss a recent report from the UK Health Protection Agency attributing a case of variant Creutzfeldt-Jakob (vCJD) disease infection to treatment 11 years earlier with a vCJDimplicated plasma-derived coagulation factor VIII (pdFVIII) and whether this information or any other recent scientific information about the vCJD epidemic substantially alters FDA's risk assessment for U.S.-licensed preparations of pdFVIII products. The committee also will hear informational presentations on animal models of vCJD, diagnostic test development for transmissible spongiform encephalopathies (TSEs) and bovine spongiform encephalopathy (BSE) surveillance and risk management.
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE WITH THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE
DATE: June 29-30, 0800/1200
LOCATION: Marriott Conference Centers, UMUC Inn and Conference Center, 3501 University Blvd. East, Adelphi, Md.
CONTACT: Elaine Ferguson, 301-827-7001
The committees will discuss how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter and prescription products.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn) Keywords: FDA ADVISORY/DIARY
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