Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee

Committee Meeting on March 10, 2011, from 8 a.m. to 5 p.m.

Agenda: On March 10, 2011, the committee will discuss, in general, the use of historical-controlled trials for the approval of anticonvulsant monotherapy for seizures of partial origin for antiepileptic drug products that are already approved for adjunctive therapy. The committee will also discuss how this may specifically apply to the approval of the supplemental new drug application 022115/S–011, LAMICTAL XR (lamotrigine extended release tablets), sponsored by SmithKline Beecham Corp. d/b/a GlaxoSmithKline, for monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug.

Anesthetic and Life Support Drugs Advisory Committee

Anesthetic and Life Support Drugs Advisory Committee

Committee Meeting on March 10, 2011, from 8 a.m. to 4:30 p.m.

Agenda: On March 10, 2011, the committee will: (1) Receive updates regarding neurodegenerative findings (findings related to degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results from human epidemiological studies using anesthesia in children (information related to studies of patterns and causes of disease); (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies; and (3) discuss the potential implications of these data upon the practice of pediatric anesthesia as well as the communication of the risk of sedative/anesthetic agents to prescribers and parents.

Pulmonary-Allergy Drugs Advisory Committee

Pulmonary-Allergy Drugs Advisory Committee

Committee Meeting on March 8, 2011, from 8 a.m. to 5 p.m.

Agenda: On March 8, 2011, the committee will discuss new drug application (NDA) 022-383, indacaterol maleate (ARCAPTA NEOHALER), by Novartis Pharmaceuticals Corp., for the long-term once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.

Vaccines and Related Biological Products Advisory Committee

Vaccines and Related Biological Products Advisory Committee

Committee Meeting on February 25, 2011, between approximately 8:30 a.m. and 1:50 p.m.

Agenda: On February 25, 2011, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update on Pandemic Influenza Surveillance.

Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee

Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee

Committee Meeting on February 11, 2011, from 9 a.m. to 5 p.m.

Agenda: On February 11, 2011, the subcommittee will receive presentations and discuss the timelines and structure of the Tobacco Products Scientific Advisory Committee''s required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health.

Tobacco Products Scientific Advisory Committee

Tobacco Products Scientific Advisory Committee

Committee Meeting on February 10, 2011, from 8 a.m. to 5 p.m.

Agenda: On February 10, 2011, the Committee will continue to do the following: (1) Receive updates from the Menthol Report Subcommittee and(2) receive and discuss presentations regarding the data requested by the Committee at the March 30 through 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committe

Committee Meeting on January 26, 2011 from 8 a.m. to 6 p.m.

Agenda: On January 26, 2011, the committee will discuss, make recommendations and vote on information related to the PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX Acculink is indicated for treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined as follows:1. Patients with neurological symptoms and >50 percent stenosis of the common or internal carotid artery or patients without neurological symptoms and >80 percent (high risk) or >70 percent (standard risk) stenosis of the common or internal carotid artery and 2. Patients must have a reference vessel diameter within the range of 4.0 and 9.0 mm at the target lesion.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Committee Meeting on January 25, 2011 from 8 a.m. to 6 p.m.

Agenda: On January 25, 2011, the committee will discuss and make recommendations regarding regulatory classification of Automated External Defibrillators to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class II (subject to premarket notification (510(k))), as directed by section 515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e(i)).

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee

February 8, 2011, from 8 a.m. to 5 p.m.

Agenda: The committee will hear updates on new drug applications (NDAs) and biologics license applications (BLAs) approved under 21 CFR 314.500 and 601.40 (subpart H and subpart E, respectively, accelerated approval regulations) prior to January 1, 2009. These updates will provide information related to the status of phase IV clinical studies and to difficulties associated with completion of phase IV commitments. Phase IV studies are post marketing studies to confirm clinical benefit of a drug after it receives accelerated approval.

Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee

January 27th and 28th, 2011 from 8:00 a.m. to 6:00 p.m

Agenda: On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.