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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 4/24/14-4/24/14

Meeting Details:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).

 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 2/22/13-2/22/13

Meeting Details:

On February 22, 2013, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace Responsive Neurostimulation (RNS) System sponsored by NeuroPace, Inc. The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 12/10/12-12/10/12

Meeting Details:

On December 10, 2012, the committee will discuss current knowledge about the safety and effectiveness of the CoAxia NeuroFlo Catheter device for the intended use of diverting cardiac output to the cerebral vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke within 14 hours of symptom onset.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Neurological Devices Panel

Meeting Date: 11/1/12-11/1/12

Meeting Details:

On November 1, 2012, the committee will discuss current knowledge about the safety and effectiveness of the CoAxia NeuroFlo Catheter device for the intended use of diverting cardiac output to the cerebral vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke within 14 hours of symptom onset.

 

       
Location: Hilton, Washington, DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 3/23/12-3/23/12

Meeting Details:

On March 23, 2012, the committee will discuss current knowledge about the safety and effectiveness of the Wingspan Stent System with Gateway PTA Balloon Catheter for the treatment of intracranial arterial stenosis. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of this device based on the available premarket and postmarket data. The Wingspan Stent System with Gateway PTA Balloon Catheter is a neurovascular stent, balloon catheter, and delivery system consisting of the following components: 1. Wingspan Stent--This is a self-expanding, nitinol stent with a tubular mesh design. 2. Gateway PTA Balloon Catheter--This balloon catheter is used to predilate the lesion prior to introduction of the Wingspan Stent System into the patient. 3. Wingspan Delivery System--This delivery system is a single lumen, over-the-wire, coaxial microcatheter that is used to deliver the stent to the treatment site within the patient's artery.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-7:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 2/10/12-2/10/12

Meeting Details:

On February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final, would make CES devices Class III requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov1 under docket number FDA-2011-N-0504. The committee discussion will include the existing data to support CES safety and effectiveness and whether the data are sufficient to develop special controls to support regulation of these devices under Class II.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 3/17/11-3/18/11

Meeting Details:

On March 17, 2011, the committee will discuss, make recommendations and vote on information related to the premarket approval application (PMA) for the NovoTTF-100A Treatment Kit, sponsored by Hogan Lovells US LLP for NovoCure, Ltd. The NovoTTF-100A Treatment Kit is intended as a treatment for adult patients (greater than 21 years of age) with histologically- or radiologically-confirmed glioblastoma multiforme (GBM), following recurrence in the supra-tentorial region of the brain. The device is intended to be used as a monotherapy, after surgical and radiation options have been exhausted, in place of standard medical therapy for GBM. On March 18, 2011, the committee will discuss, make recommendations and vote on information related to the PMA for the PIPELINE EMBOLIZATION Device (PED), sponsored by Chestnut Medical. The PED is indicated for the endovascular treatment of large or giant wide-necked intracranial aneurysms in the paraclinoid region of the internal carotid artery.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 1/27/11-1/28/11

Meeting Details:

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.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 10/8/10-10/8/10

Meeting Details:

The committee will discuss and make recommendations regarding clinical trial design issues for devices indicated for the treatment of depression.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 3/12/10-3/12/10

Meeting Details:

On March 12, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. This device is indicated as adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. For this device, a patient's epilepsy should be characterized by partial-onset seizures (affecting only a part of the brain when they begin), with or without secondary generalization that are refractory to antiepileptic medications. ``Secondary generalization'' is used to describe a partial-onset seizure that later spreads to the whole brain. ``Refractory'' to antiepileptic medications means that the patient's epilepsy does not respond to approved medications.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Neurological Devices Panel of the Medical Devices

Meeting Date: 11/20/09-11/20/09

Meeting Details:

*** Meeting Postponed *** On November 20, 2009, the committee will discuss, make recommendations and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc. This device is indicated as adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. For this device, a patient's epilepsy should be characterized by partial-onset seizures (affecting only a part of the brain when they begin), with or without secondary generalization, that are refractory to antiepileptic medications. Secondary generalization is used to describe a partial-onset seizure that later spreads to the whole brain. Refractory to antiepileptic medications means that the patient's epilepsy does not respond to approved medications.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 5/14/09-5/14/09

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for the DuraSeal XactTM Sealant System, sponsored by Confluent Surgical Inc. This device is indicated for use as an adjunct to sutured dural repair to obtain watertight closure during spinal surgery.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 1/26/07-1/26/07

Meeting Details:

The committee will discuss and make recommendations on a premarket notification application, sponsored by Neuronetics, Inc., for the NeuroStar System for the treatment of major depressive disorder. The committee will also hear and discuss post approval study reports for two recently approved neurological device premarket approval applications: The VNS Therapy\TM\ System, sponsored by Cyberonics, Inc., for treatment-resistant chronic or recurrent depression; and the Dural Sealant System, sponsored by Confluent Surgical, Inc., for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 10/31/06-10/31/06

Meeting Details:

The committee will discuss and make recommendations on a premarket notification application for a device intended for the treatment of major depressive disorder. The committee will also hear and discuss the post approval study reports for two recently approved neurological device premarket approval applications.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 6/17/05-6/17/05

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. The committee will also hear an update on the status of recent devices brought before the committee. Subsequently, the committee will discuss, make recommendations, and vote on a premarket approval application for a selective head cooling system intended for use in infants 36 weeks of gestation or older at risk for moderate to severe hypoxic-ischemic encephalopathy (HIE) to prevent or reduce the severity of HIE.

 

       
Location: Hilton Washington Gaithersburg, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices

Meeting Date: 11/30/04-11/30/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 6/15/04-6/15/04

Meeting Details:

The committee will discuss, make recommendations, and vote on premarket approval application supplement for a vagus nerve stimulation therapy system. The system is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients who are experiencing a major depressive episode that has not had an adequate response to two or more antidepressant treatments.

 

       
Location: Holiday Inn, GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 2/23/04-2/23/04

Meeting Details:

The committee will discuss and make recommendations on a premarket notification submission for a thrombectomy device.

 

       
Location: Hilton Washington Gaithersburg, MD Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Panel

Meeting Date: 8/5/03-8/5/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a neurological embolization device.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 10:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 11/17/00-11/17/00

Meeting Details:

The committee will discuss and make recommendations on: (1) the design of clinical trials for devices to prevent stroke, to treat stroke, and to provide neurological protection after stroke, and (2) the design of clinical studies for temperature control devices to provide neurological protection.

 

       
Location: Quality Suites Hotel Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 5/11/00-5/11/00

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for an embolization device.

 

       
Location: Corporate Blvd., Rockville, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 3/31/00-3/31/00

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for a deep brain stimulator for the treatment of Parkinson's disease. The device is a product of the Medtronic Corporation.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 9/16/99-9/17/99

Meeting Details:

On September 16, 1999, the committee will discuss and make recommendations on: (1) the draft FDA guidance document "Guidance Document for Dura Substitute Devices"; and (2) the classification of processed human dura mater. FDA notes that a guidance document related to the classification of processed human dura mater "Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater" became effective on July 31, 1999. On September 17, 1999, the committee will discuss and make recommendations on: (1) the draft FDA guidance document "Guidance Document for Neurological Embolization Devices"; and (2) the reclassification of the totally implanted spinal cord stimulator.

 

       
Location: Corporate Bldg. Conference room 020B 9200 Corpor Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological CFS Shunts

Meeting Date: 1/8/99-1/8/99

Meeting Details:

Our agenda will include four primary sessions with presentations from leaders in the field of neurosurgery and representatives from FDA and CDC. Following the four issue-specific sessions a panel will convene to focus on setting priorities for future efforts in research and development of shunt technology. Session topics include: Shunt Technology Perspectives Pathophysiology and Evaluation of Shunt Performance Challenges of Infection and New Perspectives Clinical Outcomes and Methods of Surveillance PANEL DISCUSSION: "Future Directions – Establishing Priorities"

 

       
Location: National Naval Medical Center Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 6/12/98-6/12/98

Meeting Details:

Introduction to 515(i) Reclassification Deliberations for the Artificial Embolization Device Intended for Neurological use.

 

       
Location: Corporate Building Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

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Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm (Forrest Labs)

Meeting Date: 9/9/14-9/9/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 9/10/14-9/10/14

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Meeting Details:

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Methodological Considerations in Evaluation of Cancer

Meeting Date: 9/10/14-9/11/14

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Meeting Details:

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

 

       
Location: The DoubleTree by Hilton Hotel Washington DC—Silver Spring The Pinnacle Grand Ballroom 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Endocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

Meeting Date: 9/11/14-9/11/14

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Endocrinologic and Metabolic Drugs AdComm (NPS Pharma)

Meeting Date: 9/12/14-9/12/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Bone, Reproductive and Urologic Drugs AdComm

Meeting Date: 9/17/14-9/18/14

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Meeting Details:

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| FDA’s GDUFA Public Hearing on Policy Development

Meeting Date: 9/17/14-9/17/14

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Meeting Details:

FDA is hosting the Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation. FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics. We will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities.

 

       
Location: College Park Marriott Hotel and Conference Center 3501 University Boulevard East Hyattsville, MD 20783 Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Pediatric AdComm

Meeting Date: 9/23/14-9/23/14

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Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Gastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

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Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

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Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 8/14/14-8/14/14

Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsConfidentiality of Interim Results in Cardiovascular Outcome Safety Trials

Meeting Date: 8/11/14-8/11/14

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/1/14-8/1/14

Meeting Details:

On August 1, 2014, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed indication for use for the TissuGlu Surgical Adhesive device, as stated in the PMA is as follows: TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Comm

Meeting Date: 7/31/14-7/31/14

Meeting Details:

On the morning of July 31, 2014, the committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. In the afternoon, the Committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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