Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Meeting on December 9, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)
Agenda: On December 9, 2011, the committees will discuss the benefits and risks of ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system), marketed by Janssen Pharmaceuticals, Inc., for the prevention of pregnancy. Specifically, the committees will discuss the possibly increased risk of thrombotic (blood clots) and thromboembolic events (blood clots that can break loose and move within the circulatory system) in users of ORTHO EVRA compared to women who use commonly prescribed birth control pills, as suggested by postmarketing studies.
Tuesday, September 27, 2011
Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
Meeting on December 8, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)
Agenda: On December 8, 2011, the committees will discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.
Meeting on December 8, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)
Agenda: On December 8, 2011, the committees will discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.
Wednesday, September 21, 2011
Prescription Drug User Fee Act
Prescription Drug User Fee Act
Meeting on October 24, 2011, from 9 a.m. to 5 p.m.
Agenda: Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Meeting on October 24, 2011, from 9 a.m. to 5 p.m.
Agenda: Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Risk Communication Advisory Committee
Risk Communication Advisory Committee,
Meeting on November 18, 2011, from 8 a.m. to 2 p.m (Day 2 of 2)
Agenda: On November 18, 2011, the committee will discuss implications, for strategic communication, of recent theoretical developments on information use in decision making.
Meeting on November 18, 2011, from 8 a.m. to 2 p.m (Day 2 of 2)
Agenda: On November 18, 2011, the committee will discuss implications, for strategic communication, of recent theoretical developments on information use in decision making.
Risk Communication Advisory Committee
Risk Communication Advisory Committee
Meeting on November 17, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)]
Agenda: On November 17, 2011, the committee will discuss results of a literature review (as required in the Patient Protection and Affordable Care Act (Pub. L. 111–148) about communicating quantitative risk and benefit information in prescription drug promotional labeling and print advertising, and will also receive a briefing on activities in FDA’s Office of Special Health Issues.
Meeting on November 17, 2011, from 8 a.m. to 5 p.m. (Day 1 of 2)]
Agenda: On November 17, 2011, the committee will discuss results of a literature review (as required in the Patient Protection and Affordable Care Act (Pub. L. 111–148) about communicating quantitative risk and benefit information in prescription drug promotional labeling and print advertising, and will also receive a briefing on activities in FDA’s Office of Special Health Issues.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Meeting on November 2, 2011, from 8 a.m. to 3:30 p.m.
Agenda: On November 2, 2011, the subcommittee will consider and discuss regulatory, academic, and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/ pharmacodynamic studies to support a pediatric indication for anticoagulants.
Meeting on November 2, 2011, from 8 a.m. to 3:30 p.m.
Agenda: On November 2, 2011, the subcommittee will consider and discuss regulatory, academic, and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/ pharmacodynamic studies to support a pediatric indication for anticoagulants.
Tuesday, September 20, 2011
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on November 3, 2011, from 9 a.m. to 5 p.m.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on November 3, 2011, from 9 a.m. to 5 p.m.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on November 2, 2011, from 9 a.m. to 5 p.m.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting on November 2, 2011, from 9 a.m. to 5 p.m.
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on October 27 2011, from 8 a.m. to 6 p.m. (Day 2 of 2]
Agenda: On October 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Medtronic Ablation Frontiers Cardiac Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation Frontiers Cardiac Ablation System is a catheter-based device developed for the treatment of atrial fibrillation. The system consists of the following: The Pulmonary Vein Ablation Catheter, which is designed to create lesions in the left atrium via five pairs of electrodes to isolate the pulmonary veins. It has a deflectable distal end and bidirectional steering to aid in positioning the catheter appropriately. The Multi-Array Septal Catheter, which is designed to create lesions on the septal wall of the left atrium via six pairs of electrodes. It is not steerable and is intended to be used in a transseptal approach. The Multi-Array Ablation Catheter, which is designed to create ‘‘X’’-like lesions in the left and/or right atrium via four pairs of electrodes. It has a deflectable distal segment and bidirectional steering within a single plane.
Meeting on October 27 2011, from 8 a.m. to 6 p.m. (Day 2 of 2]
Agenda: On October 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Medtronic Ablation Frontiers Cardiac Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation Frontiers Cardiac Ablation System is a catheter-based device developed for the treatment of atrial fibrillation. The system consists of the following: The Pulmonary Vein Ablation Catheter, which is designed to create lesions in the left atrium via five pairs of electrodes to isolate the pulmonary veins. It has a deflectable distal end and bidirectional steering to aid in positioning the catheter appropriately. The Multi-Array Septal Catheter, which is designed to create lesions on the septal wall of the left atrium via six pairs of electrodes. It is not steerable and is intended to be used in a transseptal approach. The Multi-Array Ablation Catheter, which is designed to create ‘‘X’’-like lesions in the left and/or right atrium via four pairs of electrodes. It has a deflectable distal segment and bidirectional steering within a single plane.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on October 26, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On October 26, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open concomitant cardiac surgery. The AtriCure Synergy Ablation System consists of the following: The AtriCure Isolator Synergy Handpieces (models OLL2 and OSL2), which resemble surgical clamps, include a syringe-type grip handle/ actuator, connected by a cylindrical shaft to a pair of grasping jaws with electrodes on each jaw. The electrodes deliver radiofrequency (RF) energy to the tissue grasped by the jaws. The Ablation and Sensing Unit is an RF generator used to power the Isolator Synergy Handpieces. The Isolator Switch Matrix is an accessory interface module allowing the Isolator Synergy Handpieces to connect to the RF generator.
Meeting on October 26, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)
Agenda: On October 26, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open concomitant cardiac surgery. The AtriCure Synergy Ablation System consists of the following: The AtriCure Isolator Synergy Handpieces (models OLL2 and OSL2), which resemble surgical clamps, include a syringe-type grip handle/ actuator, connected by a cylindrical shaft to a pair of grasping jaws with electrodes on each jaw. The electrodes deliver radiofrequency (RF) energy to the tissue grasped by the jaws. The Ablation and Sensing Unit is an RF generator used to power the Isolator Synergy Handpieces. The Isolator Switch Matrix is an accessory interface module allowing the Isolator Synergy Handpieces to connect to the RF generator.
Wednesday, September 14, 2011
Endocrinologic and Metabolic Drugs Advisory Committee
Endocrinologic and Metabolic Drugs Advisory Committee,
Meeting on November 2, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On November 2, 2011, the committee will discuss supplemental new drug applications 21–687 and 21– 445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering- Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3- methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipidsin the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.
Meeting on November 2, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On November 2, 2011, the committee will discuss supplemental new drug applications 21–687 and 21– 445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering- Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3- methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipidsin the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.
Vaccines and Related Biological Products Advisory Committee
Vaccines and Related Biological Products Advisory Committee
Meeting on November 16, 2011, from approximately 8 a.m. to 5:30 p.m.
Agenda: On November 16, 2011, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will also hear an update on the evaluation of Gullian-Barre Syndrome after Influenza Vaccine among Medicare population, 2010-2011. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.
Meeting on November 16, 2011, from approximately 8 a.m. to 5:30 p.m.
Agenda: On November 16, 2011, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will also hear an update on the evaluation of Gullian-Barre Syndrome after Influenza Vaccine among Medicare population, 2010-2011. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.
Prescription Drug User Fee Act
Prescription Drug User Fee Act
Meeting on October 24, 2011, from 9 a.m. to 5 p.m.
Agenda: Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Meeting on October 24, 2011, from 9 a.m. to 5 p.m.
Agenda: Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to collect prescription drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on October 13, 2011, from 8 a.m. to 6 p.m.
Agenda: On October 13, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Cook, Inc., ZILVER–PTX Drug-Elutin Stent. The ZILVER–PTX Stent is a selfexpanding nitinol stent coated on its outer surface with the cytotoxic drug paclitaxel without any polymer, binder,or excipient at a dose density of 3 micrograms/square millimeter. The ZILVER–PTX Stent is available in diameters ranging from 5 to 10 millimeters (mm) and lengths of 20 to 80 mm and are pre-loaded onto 6 or 7 Fr 1 (diameter of 2 or 2.3 mm) delivery systems. Upon deployment, the ZILVER–PTX Stent expands to establish and maintain patency in the stented region. The proposed indications for use are: treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm and total lesion lengths perpatient of 280 mm.
Meeting on October 13, 2011, from 8 a.m. to 6 p.m.
Agenda: On October 13, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Cook, Inc., ZILVER–PTX Drug-Elutin Stent. The ZILVER–PTX Stent is a selfexpanding nitinol stent coated on its outer surface with the cytotoxic drug paclitaxel without any polymer, binder,or excipient at a dose density of 3 micrograms/square millimeter. The ZILVER–PTX Stent is available in diameters ranging from 5 to 10 millimeters (mm) and lengths of 20 to 80 mm and are pre-loaded onto 6 or 7 Fr 1 (diameter of 2 or 2.3 mm) delivery systems. Upon deployment, the ZILVER–PTX Stent expands to establish and maintain patency in the stented region. The proposed indications for use are: treatment of de novo or restenotic symptomatic vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 9 mm and total lesion lengths perpatient of 280 mm.
Monday, September 12, 2011
Endocrinologic and Metabolic Drugs Advisory Committee
Endocrinologic and Metabolic Drugs Advisory Committee
Meeting on November 2, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On November 2, 2011, the committee will discuss supplemental new drug applications 21–687 and 21– 445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering- Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3- methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipidsin the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.
Meeting on November 2, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On November 2, 2011, the committee will discuss supplemental new drug applications 21–687 and 21– 445, VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, MSP (Merck/Schering- Plough) Singapore Company, LLC. Simvastatin lowers lipids (fats that circulate in the bloodstream, including cholesterol) by inhibiting 3-hydroxy-3- methyl-glutaryl-CoA reductase, which is an enzyme involved in producing lipidsin the body, and ezetimibe lowers lipids by inhibiting the absorption of cholesterol from the intestine. The proposed indication (use) of ZETIA in combination with simvastatin or VYTORIN is to reduce major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP). SHARP was a clinical trial that studied the effect of VYTORIN compared with placebo on the occurrence of major cardiovascular events in patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization (heart bypass surgery or opening heart vessels with a balloon or stents). The primary outcome of major cardiovascular events was defined as the first occurrence of either nonfatal myocardial infarction, cardiac death, stroke, or coronary or noncoronary revascularization (including nontraumatic amputation). The primary analysis demonstrated that assignment to VYTORIN significantly reduced the relative risk of a major cardiovascular event by 16% compared to placebo.
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