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.
Thursday, February 16, 2012
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.
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.
Neurological Devices Panel of the Medical Devices Advisory Committee
Neurological Devices Panel of the Medical Devices Advisory Committee
Committee meeting on March 23, 2012 from 8:00 a.m. to 7:00 p.m.
Agenda: 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:
Wingspan Stent--This is a self-expanding, nitinol stent with a tubular mesh design.
Gateway PTA Balloon Catheter--This balloon catheter is used to predilate the lesion prior to introduction of the Wingspan Stent System into the patient.
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.
The Wingspan Stent System with Gateway PTA Balloon Catheter has been approved under a humanitarian device exemption (HDE) (H050001) for the following indications: "The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥ 50% stenosis that are accessible to the system.
Committee meeting on March 23, 2012 from 8:00 a.m. to 7:00 p.m.
Agenda: 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:
Wingspan Stent--This is a self-expanding, nitinol stent with a tubular mesh design.
Gateway PTA Balloon Catheter--This balloon catheter is used to predilate the lesion prior to introduction of the Wingspan Stent System into the patient.
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.
The Wingspan Stent System with Gateway PTA Balloon Catheter has been approved under a humanitarian device exemption (HDE) (H050001) for the following indications: "The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥ 50% stenosis that are accessible to the system.
Gastrointestinal Drugs Advisory Committee Meeting
Gastrointestinal Drugs Advisory Committee Meeting
Committee Meeting March 13th 2012, from 8:00 a.m. to 5:00 p.m.
Agenda: On March 13, 2012 from 8 a.m. to 12:30 p.m., the committee will discuss and provide general advice on the appropriate target populations, objectives and designs of trials intended to evaluate products for the control of hyperbilirubinemia (increased levels of bilirubin in the body) in newborn infants.
Committee Meeting March 13th 2012, from 8:00 a.m. to 5:00 p.m.
Agenda: On March 13, 2012 from 8 a.m. to 12:30 p.m., the committee will discuss and provide general advice on the appropriate target populations, objectives and designs of trials intended to evaluate products for the control of hyperbilirubinemia (increased levels of bilirubin in the body) in newborn infants.
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting March 2, 2012 from 8:00 a.m. to 1:00 p.m. (Day 2 of 2)
Agenda: As part of the TPSAC’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting March 2, 2012 from 8:00 a.m. to 1:00 p.m. (Day 2 of 2)
Agenda: As part of the TPSAC’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. 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 March 1, 2012 from 1:00 p.m. to 5:00 p.m. (Day 1 of 2)
Agenda: As part of the TPSAC’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Committee Meeting March 1, 2012 from 1:00 p.m. to 5:00 p.m. (Day 1 of 2)
Agenda: As part of the TPSAC’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.
Wednesday, February 15, 2012
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.
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.
[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.
Oncologic Drugs Advisory Committee Meeting
Oncologic Drugs Advisory Committee Meeting
Committee Meeting on March 21, 2012 from 8:00 a.m. to 12:30 p.m. (Day 2 of 2)
The committee will discuss New Drug Application (NDA) 202497, with the proposed trade name Marqibo (vincristine sulfate liposomes injection), application submitted by Talon Therapeutics, Incorporated. The proposed indication (use) for this product is for the treatment of adult patients with Philadelphia Chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of anti-leukemia therapy.
Committee Meeting on March 21, 2012 from 8:00 a.m. to 12:30 p.m. (Day 2 of 2)
The committee will discuss New Drug Application (NDA) 202497, with the proposed trade name Marqibo (vincristine sulfate liposomes injection), application submitted by Talon Therapeutics, Incorporated. The proposed indication (use) for this product is for the treatment of adult patients with Philadelphia Chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of anti-leukemia therapy.
Oncologic Drugs Advisory Committee Meeting
Oncologic Drugs Advisory Committee Meeting
[Committee Meeting on March 20, 2012 from 8:00 a.m. to 5:00 p.m. (Day 1 of 2)]
During the morning session, the committee will discuss supplemental New Drug Application (sNDA) 022465/S-010, with the trade name Votrient (pazopanib hydrochloride) tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd doing business as GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The phase 3 STS trial population excluded patients with adipocytic STS or gastrointestinal stromal tumors (GIST).
During the afternoon session, the committee will discuss New Drug Application (NDA) 022576, with the proposed trade name Taltorvic (ridaforolimus) tablets, application submitted by Merck Sharp & Dohme Corp. The proposed indication (use) for this product is for the treatment of adult and pediatric patients (aged 13 through 17 years with weight over 100 lb or 45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least 4 cycles of chemotherapy without evidence of disease progression.
[Committee Meeting on March 20, 2012 from 8:00 a.m. to 5:00 p.m. (Day 1 of 2)]
During the morning session, the committee will discuss supplemental New Drug Application (sNDA) 022465/S-010, with the trade name Votrient (pazopanib hydrochloride) tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd doing business as GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The phase 3 STS trial population excluded patients with adipocytic STS or gastrointestinal stromal tumors (GIST).
During the afternoon session, the committee will discuss New Drug Application (NDA) 022576, with the proposed trade name Taltorvic (ridaforolimus) tablets, application submitted by Merck Sharp & Dohme Corp. The proposed indication (use) for this product is for the treatment of adult and pediatric patients (aged 13 through 17 years with weight over 100 lb or 45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least 4 cycles of chemotherapy without evidence of disease progression.
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