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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/12/13-12/12/13

Meeting Details:

On December 12, 2013, during Session I, the committee will discuss and make recommendations regarding the classification of spinal sphere devices. These devices are spheres manufactured from metallic (e.g., cobalt chromium molybdenum) or polymeric (e.g., polyetheretherketone) materials. They are intended to be inserted between the vertebral bodies into the disc space from L3-S1 to help provide stabilization and to help promote intervertebral body fusion. During the arthrodesis procedure, they are to be used with bone graft. These devices are not intended for use in motion-sparing, non-fusion procedures. Spinal sphere devices are considered preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Spinal sphere devices are currently regulated under the heading of "Intervertebral Fusion Device with Bone Graft, Solid-Sphere, Lumbar", Product Code NVR, as unclassified devices and reviewed under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness of spinal sphere devices and the regulatory classification for spinal sphere devices. On December 12, 2013, during Session II, the committee will discuss and make recommendations regarding the reclassification petition received on November 20, 2012, from DEKA Research & Development Corp. requesting that FDA reclassify stair climbing wheelchairs (21 CFR 890.3890) from Class III to Class II. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted 3 to a sitting position. The device is intended to climb stairs. On June 12, 2013 (78 FR 35173), FDA issued a proposed order which, if made final, would reclassify stair-climbing wheelchairs as Class II subject to premarket notification (510(k)) and special controls. The petitioner has one stair-climbing wheelchair approved, the iBot (P020033), and it is indicated for the following: to provide indoor and outdoor mobility in confined spaces, at an elevated height, climb curbs, ascend/descend stairs, traverse obstacles, travel over a wider variety of terrain, and negotiate uneven/inclined surfaces. Stair-climbing wheelchairs are preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Stair-climbing wheelchairs are currently regulated as Class III devices. A call for premarket approval (PMA) applications was issued on April 13, 2000 (effective July 12, 2000) (65 FR 19834). The committee's discussion will include recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of stair-climbing wheelchairs. On December 12, 2013, during Session III, the committee will discuss and make recommendations regarding the possible reclassification of mechanical wheelchairs (21 CFR 890.3850) from Class I, currently subject to premarket notification (510(k)), to Class II, subject to special controls. The mechanical wheelchairs are being considered for exemption from premarket notification (510(k)) requirements. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted 4 to a sitting position. No proposed order has been issued for this proposed change in classification. Mechanical wheelchairs are preamendment devices because they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. Mechanical wheelchairs are currently regulated as Class I devices that are subject to premarket notification (510(k)) requirements (48 FR 53041). The committee will discuss whether general and/or special controls are appropriate to demonstrate a reasonable assurance of safety and effectiveness of mechanical wheelchairs and whether, if reclassified to Class II, these devices should be exempt from premarket notification (510(k)) requirements.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 7/24/13-7/25/13

Meeting Details:

On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space. On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5- S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 4/5/13-4/5/13

Meeting Details:

On April 5, 2013, the committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave Diathermy devices Class III, requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2012-N-0378.

 

       
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 9/21/12-9/21/12

Meeting Details:

On September 21, 2012, the committee will discuss and make recommendations regarding the classification of posterior cervical screws, including pedicle and lateral mass screws. Cervical pedicle and lateral mass screws are components of rigid, posterior spinal screw and rod systems generally intended as an adjunct to fusion for the treatment of degenerative disc disease (as defined by neck pain confirmed by radiographic studies), trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the cervical spine.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 5/12/11-5/12/11

Meeting Details:

On May 12, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without necessitating an additional invasive procedure to harvest the graft.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 7/27/10-7/27/10

Meeting Details:

On July 27, 2010, the committee will discuss, make recommendations and vote on a premarket approval application for the AMPLIFY rhBMP-2 Matrix, sponsored by Medtronic, Inc. The AMPLIFY rhBMP-2 Matrix is used for posterolateral fusion treatment of single level lumbar (L2S1) degenerative disc disease.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 3/23/10-3/23/10

Meeting Details:

On March 23, 2010, the committee will discuss and make recommendations on issues relevant to FDA's reevaluation of the ReGen Collagen Scaffold (CS) device (marketed as the Menaflex[reg]), which FDA cleared in K082079 on December 18, 2008, sponsored by ReGen Biologics, Inc. The indications for use statement for this device states that the device is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 11/4/09-11/4/09

Meeting Details:

On November 4, 2009, the committee will discuss, make recommendations and vote on a premarket approval application for the Dynesys Spinal System, sponsored by Zimmer Spine. The Dynesys Spinal System is indicated to provide spinal alignment and stabilization in skeletally mature patients at one or two contiguous levels from L1-S1.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 8/18/09-8/19/09

Meeting Details:

On August 18, 2009, the committee will discuss, make recommendations and vote on a premarket approval application (PMA) for the CoMplete Acetabular Hip System, sponsored by DePuy Orthopaedics. This device system is intended for use as a primary joint replacement prosthesis in total hip arthroplasty, and is indicated for skeletally mature patients suffering severe pain and disability due to structural damage in the hip joint from non-inflammatory degenerative joint disease and its composite diagnoses of osteoarthritis or post-traumatic arthritis. On August 19, 2009, the committee will discuss, make recommendations and vote on a PMA for Durolane, sponsored by Q-Med AB. This device is indicated for the treatment of pain caused by osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy and simple analgesics, e.g., acetaminophen.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 3/31/09-3/31/09

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for OP-1 Putty, sponsored by Stryker Biotech. This combination product is indicated for posterolateral spinal fusion procedures in skeletally mature patients with lumbar spondylolisthesis who have failed at least 6 months of conservative nonsurgical treatment.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/9/08-12/9/08

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for Synvisc-One, sponsored by Genzyme Corp. This device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen.

 

       
Location: Hilton GB, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 11/14/08-11/14/08

Meeting Details:

The committee will discuss and make recommendations on a premarket notification application for the ReGen Collagen Scaffold (CS), sponsored by ReGen Biologics, Inc. This device is intended for use in surgical procedures for the reinforcement and repair of chronic soft tissue injuries of the meniscus (one to three prior surgeries to the involved meniscus) where weakness exists. In repairing and reinforcing meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.

 

       
Location: Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 7/15/08-7/15/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for Oxiplex/SP Gel, sponsored by FzioMed, Inc. This device is intended to be used as a surgical adjuvant during posterior lumbar laminectomy, larninotomy, or discectomy to improve patient outcomes by reducing postoperative leg pain, back pain, and neurological symptoms.

 

       
Location: Hilton Washington Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 7/17/07-7/17/07

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for the Bryan Total Cervical Disc Prosthesis, sponsored by Medtronic Sofamor Danek, Inc. This device is indicated in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C3-C7. DDD is defined as any combination of the following: Disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 4/24/07-4/24/07

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application (PMA) for the Scandinavian Total Ankle Replacement System, sponsored by Link America, Inc. This system is intended for use as a noncemented implant to replace a painful arthritic and/or severely deformed ankle due to rheumatoid arthritis, primary arthrosis, or posttraumatic arthrosis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/22/07-2/22/07

Meeting Details:

On February 22, 2007, the committee will discuss, make recommendations and vote on a premarket approval application for the Cormet 2000 Hip Resurfacing System, sponsored by Corin U.S.A. This system is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with non- inflammatory degenerative arthritis or inflammatory arthritis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 9/19/06-9/19/06

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for a cervical disc prosthesis intended to treat skeletally mature patients with degenerative disc disease at one level from C3-C7.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 6/2/06-6/2/06

Meeting Details:

The committee will discuss and make a recommendation on the reclassification of the noninvasive bone growth stimulator indicated for the treatment of established nonunion fractures acquired secondary to trauma and as an adjunct to the treatment of lumbar spinal fusion surgery for one or two levels.

 

       
Location: Holiday Inn Related News Links: Not Available
Time: 8:30AM-3:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices Panel

Meeting Date: 9/8/05-9/9/05

Meeting Details:

On September 8, 2005, the committee will hear a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. The committee will also hear an update on the status of recent devices brought before the committee. Subsequently, the committee will discuss, make recommendations, and vote on a premarket approval application for a hip joint metal/metal semi constrained resurfacing hybrid prosthesis (cemented femoral component). The device is intended to relieve hip pain and improve hip function in patients who have adequate bone stock and are at risk of requiring more than one hip joint replacement over their lifetimes. On September 9, 2005, the committee will discuss the design of clinical studies for spinal devices indicated for treatment of mild to moderate low back pain.

 

       
Location: Hilton Washington DC North Ballroom 620 Perry Pkwy. Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 8/31/04-8/31/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an interspinous process distraction system intended for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to mild or moderate lumbar spinal stenosis who have undergone a regimen of non-operative treatment.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 6/2/04-6/3/04

Meeting Details:

On June 2, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application for an artificial lumbar disc intended for spinal arthroplasty in skeletally mature patients with degenerative disc disease at one level from L4-S1. On June 3, 2004, from 8 a.m. to 1 p.m., the committee will discuss, make recommendations and vote on a reclassification petition for total and unicompartmental mobile bearing knee joint prostheses. Also on June 3, 2004, from 1 p.m. to 5 p.m., the committee will discuss and make recommendations on a draft guidance document for clinical performance data requirements for hip joint prostheses.

 

       
Location: Gaithersburg Marriott Related News Links: Not Available
Time: 10:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/11/03-12/11/03

Meeting Details:

The committee will discuss, make recommendations, and vote on the reclassification of the intervertebral body fusion device (cage) intended for spinal fusion procedures in skeletally mature adults with degenerative disc disease at one or two levels from C2-C7 and L2-S1 using autogenous bone graft. The device does not include combination products, such as the intervertebral body fusion device using morphogenic proteins and scaffolds.

 

       
Location: Holiday Inn GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 11/20/02-11/21/02

Meeting Details:

On November 20, 2002, the committee will discuss, make recommendations, and vote on premarket approval application (PMA) for a stair-climbing wheelchair. On November 21, 2002, the committee will discuss, make recommendations, and vote on a PMA for growth factors soaked in a collagen sponge used to treat tibial fractures. In addition, on November 21, 2002, the committee will have a general discussion on preclinical and clinical data for spinal devices.

 

       
Location: Holiday Inn, Walker/Whetstone Rooms Two Montgomery Village Ave. Gaithersburg , MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 8/8/01-8/9/01

Meeting Details:

The committee will discuss and make recommendations on the reclassification of metal on metal total hip arthroplasty devices. Also, the committee will discuss, make recommendations, and vote on premarket approval application (PMA) for a metacarpophalangeal finger joint prosthesis.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices Panel

Meeting Date: 1/19/01-1/19/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a cervical interbody fusion system.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices

Meeting Date: 7/20/00-7/20/00

Meeting Details:

The committee will discuss, make recommendations, and vote on premarket approval application (PMA) for a shock wave lithotriptor used for the treatment of heel pain and a PMA for a ceramic on ceramic total hip arthroplasty.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices Panel

Meeting Date: 11/4/99-11/5/99

Meeting Details:

On November 4th, the committee will discuss and make recommendations on the reclassification of constrained total hip arthroplasty devices. The committee will also discuss the development of computer controlled surgical systems designed for use in orthopedic procedures. On November 5th, the committee will discuss post-marketing studies of Genzyme Corporation's Carticel (autologous chondrocytes manipulated ex-vivo for structural repair) indicated for treatment and repair of clinically significant, articular cartilage defects in the knee. The discussion will focus on issues specific to these studies and on more general ones related to the feasibility of randomized controlled trials in the field of orthopedics.

 

       
Location: Corporate Bldg. Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices

Meeting Date: 10/8/98-10/9/98

Meeting Details:

On October 8, 1998, the committee will consider issues relating to the study and evaluation of spinal device assemblies. In the context of a preliminary background document, the committee will be asked to address scientific issues pertaining to the development of investigational device exemptions (IDE) applications for spinal device assemblies. This will include inclusion/exclusion criteria, type of control(s), study endpoints, and length of follow-up.

 

       
Location: Corporate Building Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopedic and Rehabilitation Devices

Meeting Date: 4/27/98-4/28/98

Meeting Details:

April 27, 1998 Panel Training - Conflict of Intrest. General and PDP training. Reclassification training. April 28, 1998 Reclassification of bone cement.

 

       
Location: FDA Corporate Building Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/30/14-10/30/14

Broadcasting Live NOW

Meeting Details:

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 11/6/14-11/6/14

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Meeting Details:

During the morning session, the committee will discuss New Drug Application (NDA) 205353, panobinostat capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. During the afternoon session, the committee will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications (uses) for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD) and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 11/14/14-11/14/14

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Meeting Details:

On November 14, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens submitted by applicant Alcon Laboratories, Inc. This intraocular lens combines the optical properties of a +3 diopter multifocal intraocular lens with the optical properties of a toric intraocular lens. The proposed indication for use is: The AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens (IOL) are intended for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

 

       
Location: Hilton/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 11/24/14-11/25/14

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Meeting Details:

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drug AdComm

Meeting Date: 12/4/14-12/4/14

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Meeting Details:

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options.

 

       
Location: The Marriott Inn and Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/12/14-12/12/14

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Meeting Details:

On December 12, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

       
Location: Holiday Inn-College Park Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 10/8/14-10/9/14

Meeting Details:

On October 8, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding the Boston Scientific Corporation’s WATCHMAN Left Atrial Appendage (LAA) Closure Technology. FDA is seeking committee review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the previous advisory committee meeting on the WATCHMAN device, which was held December 11, 2013. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is indicated to prevent thromboembolism (TE) from the left atrial appendage. It may be considered for use in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy to reduce the risk of stroke and systemic embolism based on CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes, and prior stroke or transient ischemic attack (TIA)) or CHA2DS2-VASc (congestive heart failure, hypertension, age >75 years, diabetes mellitus, stroke/TIA/TE, vascular disease, age 65-74, and sex category) scores. On October 9, the committee will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves (MMM Allograft HVs). A MMM Allograft HV is a human valve or valved conduit that has been aseptically recovered from qualified donors, dissected free from the human heart, and then subjected to a manufacturing process(es) that alters the original relevant characteristics of the tissue (21 CFR 1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then stored until needed by a recipient. An example of such a manufacturing process is one that intentionally removes the cells and cellular debris with the goal of reducing in vivo antigenicity. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated under Product Code OHA, ‘‘Heart Valve, More than Minimally Manipulated Allograft,’’ as unclassified devices and reviewed under the premarket notification, 510(k), authority (21 CFR part 807). FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/30/14-10/30/14

Broadcasting Live NOW

Meeting Description:

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).


 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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