Wednesday November 26, 05:47 PM
U.S. FDA advisory meetings through Jan 8
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EST/GMT.
ARTHRITIS ADVISORY COMMITTEE
DATE: Nov. 24, 0830/1330
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Nicole Vesely, 301-827-6793
The committee will discuss a new drug application from Takeda Pharmaceutical Co Ltd (Berlin: TKD.BE - news) for Uloric, known generically as febuxostat, for the proposed treatment of hyperuricemia in patients with gout.
ANTIVIRAL DRUGS ADVISORY COMMITTEE
DATE: Dec. 2, 0800/1300 (closed session), 1030/1530 (open session)
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Paul Tran, 301-827-7001
During the closed session, the committee will discuss and review trade secret and/or confidential information. It will then discuss the safety and efficacy of Solvay Pharmaceuticals Inc's Creon, or pancrelipase delayed-release capsules, in treating exocrine pancreatic insufficiency. Solvay Pharmaceuticals is a unit of Solvay SA (Brussels: SOLB.BR - news) .
**NOTE (Stockholm: NOTE.ST - news) : Meeting location changed**
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: Dec. 3, 0800/1300
LOCATION: Hilton, 8727 Colesville Rd., Silver Spring, Md.
CONTACT: Janie Kim, 301-827-7001
The committee will discuss a new drug application from Novartis (Virt-X: NOVN.VX - news) for artemether 20 mg/lumefantrine 120mg for the proposed indication of treatment of acute, uncomplicated malaria infection due to Plasmodium falciparum or mixed infections including P. falciparum.
IMMUNOLOGY DEVICES PANEL
DATE: Dec. 3, 0830/1330
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Dai Li, 240-276-0997
The committee will discuss and make recommendations on the premarket notification application for the Fujirebio HE4 EIA kit and associated Risk of Malignancy algorithm (ROMATM) Test. The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The HE4 EIA, used in conjunction with the ARCHITECT CA 125 II assay, creates a predictive probability of epithelial ovarian cancer using a mathematical function referred to as the ROMATM, for use in premenopausal and postmenopausal women presenting with an adnexal mass who have already been referred to an oncologic specialist and are scheduled for surgery. Subjects categorized as low risk for epithelial ovarian cancer using the ROMATM value may have surgical intervention performed by a non-oncology specialist. The results must be interpreted in conjunction with other clinical findings in accordance with standard clinical management guidelines. The assay is not indicated as an aid in a decision to proceed to surgery.
DERMATOLOGIC AND OPHTHALMIC DRUGS ADVISORY COMMITTEE
DATE: Dec. 5, 0800/1300
LOCATION: Hilton, 1750 Rockville Pike, Rockville, Md.
CONTACT: Yvette Waples, 301-827-7001
The committee will discuss a new drug application from Bausch & Lomb for besifloxacin ophthalmic solution, proposed for the treatment of bacterial conjunctivitis. The committee also will discuss a new drug application from Allergan (NYSE: AGN - news) for bimatoprost ophthalmic solution, 0.03%, proposed for the treatment of hypotrichosis of the eyelids.
ANESTHESIOLOGY AND RESPIRATORY THERAPY DEVICES PANEL
DATE: Dec 5, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Neel Patel, 240-276-3700
The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by Emphasys Medical Inc., for the Emphasys Zephyr Endobronchial Valve System, which is intended to improve forced expiratory volume in the first second (FEV1) and 6-minute walk test distance in patients with severe heterogeneous emphysema who have received optimal medical management.
ORTHOPAEDIC AND REHABILITATION DEVICES PANEL
DATE: Dec. 9, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Ronald Jean, 240-276-3676
The committee will make recommendations on whether to approve Genzyme Corp (NASDAQ: GENZ - news) 's Synvisc-One device to treat pain in osteoarthritis of the knee in patients who do no respond to conservative non-drug therapy and simple analgesics such as acetaminophen.
PEDIATRIC ETHICS SUBCOMMITTEE OF THE ADVISORY COMMITTEE
DATE: Dec. 9, 0900/1400
LOCATION: The Legacy Hotel & Meeting Centre, 1755 Rockville Pike, Rockville, Md.
The subcommittee will meet to discuss a referral by an Institutional Review Board (IRB) of a clinical investigation that involves both an FDA regulated product and research involving children as subjects that is conducted or supported by DHHS. The clinical investigation is entitled 'Children's Oncology Group Protocol ASCT0631: A Phase III Randomized Trial of Granulocyte Colony Stimulating Factor Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source in Matched Sibling Donor Transplantation.' The subcommittee will discuss the proposed protocol recommend whether the protocol should proceed.
PEDIATRIC ADVISORY COMMITTEE
DATE: Dec. 9, 1530/2030
LOCATION: The Legacy Hotel & Meeting Centre, 1755 Rockville Pike, Rockville, Md.
The committee will discuss the recommendation of the Pediatric Ethics Subcommittee from its meeting earlier on Dec. 9 regarding a referral by an Institutional Review Board of a clinical investigation that involves both an FDA-regulated product and research involving children as subjects that is conducted or supported by Department of Health and Human Services.
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
DATE: Dec. 10, 0800/1300
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Elaine Ferguson, 301-827-7001
The committee will discuss new drug application from Acusphere Inc (NASDAQ: ACUS - news) for Imagify (perflubutane polymer microspheres) injectable suspension for use as an ultrasound imaging agent indicated for patients with stable chest pain being evaluated for inducible ischemia for the detection of coronary artery disease based on assessment of myocardial perfusion and wall motion.
JOINT MEETING OF THE PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE, DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE AND PEDIATRIC ADVISORY COMMITTEE
DATE: Dec. 10-11, 0830/1330
LOCATION: Hilton, 1750 Rockville Pike, Rockville, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committees will discuss the benefit and risk assessment of long acting beta-2 adrenergic agonists for the treatment of asthma in adults and children.
OBSTETRICS AND GYNECOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Dec. 11, 0800/1300
LOCATION: Gaithersburg Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
Contact Person: Michael Bailey, 240-276-4100
The committee will discuss, make recommendations and vote on a premarket approval application for the Female Health Company's FC2 Female Condom to prevent HIV/AIDS and unintended pregnancy.
ONCOLOGIC DRUGS ADVISORY COMMITTEE
DATE: Dec. 16, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
The committee will discuss ImClone Systems Inc (NASDAQ: IMCL - news) 's Erbitux (cetuximab) and Amgen Inc's Vectibix (panitumumab) in the context of K-ras as a predictive and/or prognostic biomarker in oncology drug development.
PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE
DATE: Jan. 7-8, 0800/1300
LOCATION: Hilton, 1750 Rockville Pike, Rockville, Md.
CONTACT: Diem-Kieu Ngo, 301-827-7001
On Jan. 7, the committee will discuss a new drug application from Ovation Pharmaceuticals, Inc for vigabatrin for the proposed indication of adjunctive therapy for the treatment of refractory complex partial seizures in adults.
On Jan. 8, the committee will discuss a new drug application from Ovation Pharmaceuticals for vigabatrin for the proposed indication of treatment of infantile spasms.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)
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