Gastrointestinal Drugs Advisory Committee Meeting
Committee Meeting August 28, 2012 8:00 a.m. to 5:00 p.m.
Agenda: The committee will discuss the results from clinical trials of supplemental biologics license application (sBLA) 125057/232, for Humira (adalimumab), by Abbott Laboratories, for the proposed indication (use) for reducing signs and symptoms, and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
Tuesday, June 26, 2012
Dermatologic and Ophthalmic Drugs Advisory Committee
Dermatologic and Ophthalmic Drugs Advisory Committee
Committee Meeting July 26, 2012 8:00 a.m. to 5:00 p.m.
Agenda: During the morning session, the committee will discuss a supplement to biologics license application (BLA) 125156 for LUCENTIS (ranibizumab) injection by Genentech, Inc., for the treatment of diabetic macular edema (DME). Ranibizumab injection is currently approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO).
During the afternoon session, the committee will discuss new biologics license application (BLA) 125422, ocriplasmin intravitreal injection (proposed tradename, Jetrea) by ThromboGenics, Inc., indicated for the treatment of symptomatic vitreomacular adhesions (sVMA) including macular hole.
Committee Meeting July 26, 2012 8:00 a.m. to 5:00 p.m.
Agenda: During the morning session, the committee will discuss a supplement to biologics license application (BLA) 125156 for LUCENTIS (ranibizumab) injection by Genentech, Inc., for the treatment of diabetic macular edema (DME). Ranibizumab injection is currently approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO).
During the afternoon session, the committee will discuss new biologics license application (BLA) 125422, ocriplasmin intravitreal injection (proposed tradename, Jetrea) by ThromboGenics, Inc., indicated for the treatment of symptomatic vitreomacular adhesions (sVMA) including macular hole.
Oncologic Drugs Advisory Committee Meeting
Oncologic Drugs Advisory Committee Meeting
Committee Meeting July 25, 2012 8:00 a.m. to 12:30 p.m (Day 2 of 2)
Agenda: The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information.
Committee Meeting July 25, 2012 8:00 a.m. to 12:30 p.m (Day 2 of 2)
Agenda: The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information.
Oncologic Drugs Advisory Committee Meeting
Oncologic Drugs Advisory Committee Meeting
Committee Meeting : July 24, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)
Agenda: During the morning session, the committee will discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication (use) for this product is in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s).
During the afternoon session, the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.
Committee Meeting : July 24, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)
Agenda: During the morning session, the committee will discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication (use) for this product is in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s).
During the afternoon session, the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.
Tuesday, June 5, 2012
Oncologic Drugs Advisory Committee Meeting
Oncologic Drugs Advisory Committee Meeting
Committee Meeting July 25, 2012 8:00 a.m. to 12:30 p.m (Day 2 of 2)
Agenda: The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information.
Committee Meeting July 25, 2012 8:00 a.m. to 12:30 p.m (Day 2 of 2)
Agenda: The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information.
Oncologic Drugs Advisory Committee Meeting
Oncologic Drugs Advisory Committee Meeting
Committee Meeting : July 24, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)
Agenda: During the morning session, the committee will discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication (use) for this product is in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s).
During the afternoon session, the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.
Committee Meeting : July 24, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)
Agenda: During the morning session, the committee will discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication (use) for this product is in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s).
During the afternoon session, the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.
Risk Communication Advisory Committee
Risk Communication Advisory Committee
Committee Meeting June 29, 2012 8:00 a.m. - 3:00 p.m.
Agenda: On June 29, 2012, the Committee will discuss recent research on communicating and understanding uncertainty, and risk perception and information seeking when facing multiple risks.
Committee Meeting June 29, 2012 8:00 a.m. - 3:00 p.m.
Agenda: On June 29, 2012, the Committee will discuss recent research on communicating and understanding uncertainty, and risk perception and information seeking when facing multiple risks.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
Committee Meeting June 27th 2012 8:00 a.m. - 7:00 p.m.(Day 2 of 2)
Agenda: On June 27 and 28, 2012, the committee will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.
Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
There are two categories of metal-on-metal hip arthroplasty systems:
1. Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component). MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a. Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b. Inflammatory degenerative joint disease such as rheumatoid arthritis;
c. Correction of functional deformity; and,
d. Revision procedures where other treatments or devices have failed.
2. Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component). Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or
b. Inflammatory arthritis such as rheumatoid arthritis.
Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
Committee Meeting June 27th 2012 8:00 a.m. - 7:00 p.m.(Day 2 of 2)
Agenda: On June 27 and 28, 2012, the committee will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.
Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
There are two categories of metal-on-metal hip arthroplasty systems:
1. Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component). MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a. Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b. Inflammatory degenerative joint disease such as rheumatoid arthritis;
c. Correction of functional deformity; and,
d. Revision procedures where other treatments or devices have failed.
2. Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component). Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or
b. Inflammatory arthritis such as rheumatoid arthritis.
Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
Committee Meeting June 27th 2012 8:00 a.m. - 7:00 p.m.(Day 1 of 2)
Agenda: On June 27 and 28, 2012, the committee will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.
Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
There are two categories of metal-on-metal hip arthroplasty systems:
1. Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component). MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a. Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b. Inflammatory degenerative joint disease such as rheumatoid arthritis;
c. Correction of functional deformity; and,
d. Revision procedures where other treatments or devices have failed.
2. Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component). Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or
b. Inflammatory arthritis such as rheumatoid arthritis.
Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
Committee Meeting June 27th 2012 8:00 a.m. - 7:00 p.m.(Day 1 of 2)
Agenda: On June 27 and 28, 2012, the committee will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.
Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
There are two categories of metal-on-metal hip arthroplasty systems:
1. Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component). MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a. Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b. Inflammatory degenerative joint disease such as rheumatoid arthritis;
c. Correction of functional deformity; and,
d. Revision procedures where other treatments or devices have failed.
2. Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component). Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or
b. Inflammatory arthritis such as rheumatoid arthritis.
Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
Committee Meeting June 21, 2012 8:00 a.m. - 6:00 p.m.
Agenda: On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.
Committee Meeting June 21, 2012 8:00 a.m. - 6:00 p.m.
Agenda: On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.
Oncologic Drugs Advisory Committee
Oncologic Drugs Advisory Committee
Committee Meeting June 20, 2012 8:00 a.m. to 5:00 p.m
Agenda: During the morning session, the committee will discuss New Drug Application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score ≥ 3.
During the afternoon session, the committee will discuss New Drug Application (NDA) 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent.
Committee Meeting June 20, 2012 8:00 a.m. to 5:00 p.m
Agenda: During the morning session, the committee will discuss New Drug Application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score ≥ 3.
During the afternoon session, the committee will discuss New Drug Application (NDA) 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting June 13, 2012 8:00 a.m. - 6:00 p.m.
Agenda: On June 13, 2012, 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 SAPIEN Transcatheter Heart Valve is indicated for use in patients with symptomatic severe aortic stenosis who have high operative risk.
The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, sizes 23mm and 26mm and accessories implant system consists of the following:
• A heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in two 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.
Committee Meeting June 13, 2012 8:00 a.m. - 6:00 p.m.
Agenda: On June 13, 2012, 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 SAPIEN Transcatheter Heart Valve is indicated for use in patients with symptomatic severe aortic stenosis who have high operative risk.
The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, sizes 23mm and 26mm and accessories implant system consists of the following:
• A heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in two 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.
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