Tuesday December 9, 05:55 PM
U.S. FDA advisory meetings through Jan 9
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EST/GMT.
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 not 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 Eli Lilly unit 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.
BLOOD PRODUCTS ADVISORY COMMITTEE
DATE: Jan 9, 0800/1300
LOCATION: Hilton, 1750 Rockville Pike, Rockville, Md.
CONTACT: William Freas, 301-827-0314
In the morning, the committee will discuss CSL Behring's application for plasma-derived fibrinogen concentrate for treatment of bleeding in congenital fibrinogen deficiency. In the afternoon, the committee will hear an update on the 'Food and Drug Administration Draft Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs'. Following this update, the committee will discuss GTC Biotherapeutics (NASDAQ: GTCB - news) ' application for recombinant Antithrombin III derived from genetically engineered goats for treatment of patients with hereditary Antithrombin III deficiency to prevent thrombosis during high risk situations like surgery and obstetrical procedures.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn) Keywords: FDA ADVISORY/DIARY Keywords: FDA ADVISORY/DIARY
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