Scientific Evaluation of Modified Risk Tobacco Product Applications
Meeting on August 26, 2011, from 8:30 a.m. to 4:00 p.m. (Day 2 of 2)
Agenda: The purpose of the public workshop is to create a forum for appropriate scientific and medical experts and other interested stakeholders to provide input on these topics. FDA will take the information it obtains from the public workshop into account as it determines how best to implement the MRTPs provisions of the Tobacco Control Act. FDA is also opening a public docket to receive comments on these topics.
Monday, June 27, 2011
Scientific Evaluation of Modified Risk Tobacco Product Applications
Scientific Evaluation of Modified Risk Tobacco Product Applications
Meeting on August 25, 2011, from 8:30 a.m. to 5:30 p.m. (Day 1 of 2)
Agenda: The purpose of the public workshop is to create a forum for appropriate scientific and medical experts and other interested stakeholders to provide input on these topics. FDA will take the information it obtains from the public workshop into account as it determines how best to implement the MRTPs provisions of the Tobacco Control Act. FDA is also opening a public docket to receive comments on these topics.
Meeting on August 25, 2011, from 8:30 a.m. to 5:30 p.m. (Day 1 of 2)
Agenda: The purpose of the public workshop is to create a forum for appropriate scientific and medical experts and other interested stakeholders to provide input on these topics. FDA will take the information it obtains from the public workshop into account as it determines how best to implement the MRTPs provisions of the Tobacco Control Act. FDA is also opening a public docket to receive comments on these topics.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on July 20 and 21, 2011, from 8 a.m. to 6 p.m
Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper
Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).
Meeting on July 20 and 21, 2011, from 8 a.m. to 6 p.m
Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper
Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on July 21, 2011, from 8 a.m. to 6 p.m (Day 2 of 2)
Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).
Meeting on July 21, 2011, from 8 a.m. to 6 p.m (Day 2 of 2)
Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on July 20, 2011, from 8 a.m. to 6 p.m (Day 1 of 2)]
Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper
Meeting on July 20, 2011, from 8 a.m. to 6 p.m (Day 1 of 2)]
Agenda: On July 20, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIENTM Transcatheter Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and accessories implant system consists of the following: The Edwards SAPIEN Transcatheter Heart Valve consists of a heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in 2 sizes, a 23 mm and a 26 mm. The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper
Wednesday, June 22, 2011
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Meeting on July 14, 2011, from 8 a.m. to 5 p.m.
Agenda: On July 14, 2011, during the morning session, the committee will discuss biologics license application (BLA) 125388, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory (resistant to previous standard treatments) Hodgkin’s lymphoma. During the afternoon session, the committee will discuss BLA 125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma.
Meeting on July 14, 2011, from 8 a.m. to 5 p.m.
Agenda: On July 14, 2011, during the morning session, the committee will discuss biologics license application (BLA) 125388, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory (resistant to previous standard treatments) Hodgkin’s lymphoma. During the afternoon session, the committee will discuss BLA 125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for injection, submitted by Seattle Genetics, Inc. The proposed indication (use) for this product is for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma.
Monday, June 13, 2011
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Committee Meeting on July 19, 2011, from 8 a.m. to 5 p.m.
Agenda: On July 19, 2011, the committee will discuss new drug application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Committee Meeting on July 19, 2011, from 8 a.m. to 5 p.m.
Agenda: On July 19, 2011, the committee will discuss new drug application (NDA) 202293 dapagliflozin, manufactured by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Tuesday, June 7, 2011
Tobacco Products Scientific Advisory Committee
Tobacco Products Scientific Advisory Committee
Committee Meeting on July 21, 2011, from 9 a.m. to 5 p.m. and July 22, 2011, from 8 a.m. to 5 p.m.
Agenda: On the morning of July 21, 2011, the committee will discuss changes proposed by committee members to the Tobacco Products Scientific Advisory Committee (TPSAC) Menthol Report submitted to the Agency on March 18, 2011. The committee will consider additional oral and written comments from the public on the Menthol Report and the proposed changes to the report, as submitted according to the instructions in the Procedure portion of this document. The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee. Redacted versions of the document, reflecting the changes to the report proposed by the committee members, will be made available on the FDA Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm237359.htm, no later than June 22, 2011. On the afternoon of July 21, 2011, and on July 22, 2011, the TPSAC will initiate discussions on the issue of the nature and impact of the use of dissolvable tobacco products on the public health. These discussions will begin the process for the TPSAC’s required report to the Secretary of Health and Human Services regarding the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. The final report should take into consideration the following: (1) The risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
Committee Meeting on July 21, 2011, from 9 a.m. to 5 p.m. and July 22, 2011, from 8 a.m. to 5 p.m.
Agenda: On the morning of July 21, 2011, the committee will discuss changes proposed by committee members to the Tobacco Products Scientific Advisory Committee (TPSAC) Menthol Report submitted to the Agency on March 18, 2011. The committee will consider additional oral and written comments from the public on the Menthol Report and the proposed changes to the report, as submitted according to the instructions in the Procedure portion of this document. The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee. Redacted versions of the document, reflecting the changes to the report proposed by the committee members, will be made available on the FDA Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm237359.htm, no later than June 22, 2011. On the afternoon of July 21, 2011, and on July 22, 2011, the TPSAC will initiate discussions on the issue of the nature and impact of the use of dissolvable tobacco products on the public health. These discussions will begin the process for the TPSAC’s required report to the Secretary of Health and Human Services regarding the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. The final report should take into consideration the following: (1) The risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
Gastrointestinal Drugs Advisory Committee
Gastrointestinal Drugs Advisory Committee
Committee Meeting on July 21, 2011, from 8 a.m. to 4 p.m.
Agenda: On July 21, 2011, the committee will discuss the results from a clinical trial of supplement biologics license application 103772/5301, REMICADE (infliximab), by Centocor Ortho Biotech Inc., in the treatment of pediatric patients with moderately to severely active ulcerative colitis.
Committee Meeting on July 21, 2011, from 8 a.m. to 4 p.m.
Agenda: On July 21, 2011, the committee will discuss the results from a clinical trial of supplement biologics license application 103772/5301, REMICADE (infliximab), by Centocor Ortho Biotech Inc., in the treatment of pediatric patients with moderately to severely active ulcerative colitis.
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