Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting May 24, 2012 8:00 a.m. - 6:00 p.m

Agenda: On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) Device was the first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With more widespread use of these devices, more information has become available regarding adverse events. These events range from rare life-threatening events to more common events that are perceived to have less severe clinical sequelae. Many of these events were evident in the premarket studies; however, rare events such as erosion were not seen. The purpose of discussion of these events is: (1) to discuss the significance of these events in the overall context of the disease and existing treatment options; (2) to discuss whether additional measures should be taken to improve protection of the public health (e.g., additional study and/or data analyses, labeling changes); and (3) to communicate to patients and physicians what is and is not known about device treatment options.

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting May 11th, 2012 8:00 a.m. - 6:00 p.m. (Day 2 of 2)

Agenda: On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopically (balloons and suture devices) or laparoscopically (bands, space-occupying devices, etc.) and contrast those to surgery. Additional discussion will include issues pertaining to clinically meaningful weight loss, when the primary endpoint should be measured, length of patient followup, and how much risk is acceptable for a potentially small amount of weight loss.

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting May 10th, 2012 8:00 a.m. - 6:00 p.m. (Day 1 of 2)

Agenda: On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopically (balloons and suture devices) or laparoscopically (bands, space-occupying devices, etc.) and contrast those to surgery. Additional discussion will include issues pertaining to clinically meaningful weight loss, when the primary endpoint should be measured, length of patient followup, and how much risk is acceptable for a potentially small amount of weight loss.

Antiviral Drugs Advisory Committee

Antiviral Drugs Advisory Committee
Committee Meeting on May 11, 2012, from 8 a.m. to 5 p.m.

Agenda: The committee will discuss new drug application (NDA) 203-100, for a fixed dose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naïve or have no known substitutions associated with resistance to the individual components

Gastrointestinal Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee
Committee Meeting May 31, 2012, from 8 a.m. to 4:30 p.m.

Agenda: The committee will discuss new drug application (NDA) 200–436, synthetic human secretin, sponsored by Repligen Corporation, proposed for use with magnetic resonance imaging (MRI) to improve pancreatic duct visualization for the detection of duct abnormalities to enhance clinical decision making in patients with known or suspected pancreatitis.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee Meeting on May 10th from 8:00 a.m. to 5:00 p.m.

Agenda: The committee will discuss the safety and efficacy of new drug application (NDA) 22–529 (lorcaserin hydrochloride) tablets, manufactured by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
[Committee Meeting April 26th from 8:00 a.m. to 6:00 p.m. (Day 2 of 2)

Agenda: On April 26, 2012, the committee will discuss, make recommendations and vote on information related to the PMA for the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System sponsored by Cameron Health, Inc. The S-ICD is the first implantable defibrillator that does not require the implantation of an electrode either on or in the heart. The S-ICD is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias. The device is capable of delivering high energy defibrillation shocks as well as bradycardia demand mode cardiac pacing. The study provides data from the treatment of induced acute and chronic episodes of ventricular tachycardia/ventricular fibrillation and spontaneous episodes. In addition to the investigational device exemption study, clinical data were also obtained from using studies outside the United States and registries.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 25th from 8:00 a.m. to 6:00 p.m. (Day 1 of 2)

Agenda: On April 25, 2012, the committee will discuss, make recommendations and vote on information related to a supplement to the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS) sponsored by HeartWare, Inc. The HVAS is an implantable electrically powered centrifugal-flow rotary blood pump with external driver and power source(s). It is the first ventricular assist device that does not require the creation of an abdominal pump pocket. The HVAS is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory, advanced heart failure.

Antiviral Drugs Advisory Committee Meeting

Antiviral Drugs Advisory Committee Meeting
Committee Meeting May 10, 2012 8:00 a.m. to 5:30 p.m.

Agenda: On May 10, 2012, the committee will discuss an efficacy supplement for new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Arthritis Advisory Committee Meeting

Arthritis Advisory Committee Meeting
Committee Meeting May 9, 2012 8:00 a.m. to 5:00 p.m. (Day 2 of 2)

Agenda: On May 9, 2012, the committee will discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop
Committee Meeting May 31st, 2012 from 8:00 a.m. to 5:15 p.m. (Day 2 of 2)

Agenda: The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP.

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop
Committee Meeting May 30th, 2012 from 8:00 a.m. to 5:15 p.m. (Day 1 of 2)

Agenda: Agenda: The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP.

Arthritis Advisory Committee Meeting

Arthritis Advisory Committee Meeting
Committee Meeting May 8th from 8:00 a.m. to 5:00 p.m.

Agenda: On May 8, 2012, the committee will discuss supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation of uric-acid lowering therapy in adult patients with gout. ARCALYST has not been studied for longer than 16 weeks in this clinical setting.

Radiological Devices Panel of the Medical Devices Advisory Committee

Radiological Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 12, 2012 from 8:00 a.m. – 6:00 p.m. (Day 2 of 2)

Agenda: On April 12, 2012, during session I, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class III devices. On July 18, 1995 (60 FR 36639), FDA published a Final Rule that misbranded breast transilluminators and effectively placed them in class III based on the recommendation of the Obstetrics and Gynecology Devices Panel, which concluded there were no published studies or clinical data demonstrating the safety and effectiveness of this device. The committee discussion will include a review of the present literature to assess the current knowledge of breast transilluminators and determine if sufficient safety and effectiveness data are available to support reclassification of breast transilluminators.

During session II on April 12, 2012, the committee will discuss and make recommendations regarding the classification of blood irradiators. Blood irradiators have been found to be substantially equivalent to predicate devices marketed in interstate commerce prior to May 28, 1976, and are subject to the general controls provisions of the Federal Food, Drug and Cosmetic Act. These devices have never been formally classified. There is an agreement between the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) that outlines which FDA center will regulate these devices. CDRH regulates irradiators intended for use in the immunologically active cells in blood and other tissues and CBER regulates irradiators intended for use in the in-process inactivation of HIV viruses or other pathogens. The committee discussion will focus on whether these devices should be classified in class I, II, or III.

Radiological Devices Panel of the Medical Devices Advisory Committee

Radiological Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 11, 2012 from 8:00 a.m. – 6:00 p.m. (Day 1 of 2)

Agenda: On April 11, 2012, the committee will discuss, make recommendations, and vote on information related to a premarket approval application for the Automated Breast Ultrasound (ABUS) scanning device, sponsored by U-Systems, Inc. The ABUS scanning device is intended to increase breast cancer detection in asymptomatic dense-breasted women following a negative screening mammogram.

Anti-Infective Drugs Advisory Committee Meeting

Anti-Infective Drugs Advisory Committee Meeting
Committee Meeting April 4th From 8:00 a.m. to 3:30 p.m. (Day 2 of 2)

Agenda: On April 4, 2012, the committee will discuss the data provided to support the safety and efficacy of levofloxacin for the treatment of pneumonic plague in humans. Johnson and Johnson Pharmaceutical Research and Development, LLC (on behalf of Janssen Pharmaceuticals, Inc.) has submitted efficacy supplements for Levaquin (levofloxacin) tablets, injection, and oral solution (NDA 20-634, NDA 20-635, and NDA 21-721, respectively) for treatment of pneumonic plague. Efficacy data for levofloxacin is based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and post-marketing experience in humans.

Anti-Infective Drugs Advisory Committee Meeting

Anti-Infective Drugs Advisory Committee Meeting
Committee Meeting April 3rd From 8:00 a.m. to 5:30 p.m. (Day 1 of 2)

Agenda: On April 3, 2012, during the morning session, the committee will discuss the development of an animal model of pneumonic plague (plague infection with extensive lung involvement) in African Green monkeys and provide advice concerning the relevance of the animal model to pneumonic plague in humans resulting from exposure to Yersinia pestis (the bacteria that causes plague) in a bioterrorism event.

During the afternoon session, the committee will discuss the data provided to support the safety and efficacy of ciprofloxacin for the treatment of pneumonic plague in humans. The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for ciprofloxacin, based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and post-marketing experience in humans.

Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee

Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee
Committee Meeting April 2, 2012 8:00 a.m. to 5:00 p.m.

Agenda: The committees will provide advice on types of consumer studies needed to assess proper use of a MedKit containing doxycycline to be taken in the event of anthrax exposure. Issues such as the feasibility of an FDA-approved MedKit as a public health strategy, the role of personal MedKits, home stockpiling, and interfaces of home readiness with public health systems, will be raised in the course of the discussions. The Biomedical Advanced Research and Development Authority will propose a possible plan for a step-wise development program for MedKits containing oral doxycycline hyclate.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee March 29, 2012 from 8:00 to 5:00 (Day 2 of 2)

Agenda: On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee March 28, 2012 from 8:00 to 5:00 (Day 1 of 2)

Agenda: On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.

Cardiovascular and Renal Drugs Advisory Committee

Cardiovascular and Renal Drugs Advisory Committee
Committee Meeting March 27, 2012 8:00 a.m. to 5:00 p.m.

Agenda: On March 27, 2012, from 11:00 a.m. to 5:00 p.m. the committee will discuss biologics license application (BLA) 125410, proposed tradename REPLAGAL (agalsidase alfa), submitted by Shire Human Genetics Therapies, for an enzyme replacement therapy (ERT) for patients with Fabry disease.

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs
Committee Meeting March 23rd from 9:00 a.m. to 4:00 p.m. (Day 2 of 2)

Agenda: The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs
Committee Meeting March 22nd from 9:00 a.m. to 4:00 p.m. (Day 1 of 2)

Agenda: The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.