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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel

Meeting Date: 11/9/06-11/9/06

Meeting Details:

On November 9, 2006, from 8:30 a.m. to 5 p.m., the meeting will be open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel

Meeting Date: 10/11/05-10/12/05

Meeting Details:

On October 11, 2005, the committee will hear a presentation on the FDA Critical Path Initiative and 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. Subsequently, on October 11 and 12, 2005, the committee will discuss and make recommendations on the classification of the following unclassified dental devices. Root canal cleanser, product code KJJ, intended to cleanse a root canal after endodontic instrumentation; Retraction cord, product code MVL, intended for temporary retraction and hemostasis of the gingival margin; Root apex locator, product code LQY, intended to measure the length of the root canal; Dental mouthguards, product code MQC, intended to provide protection against bruxism, teeth clenching, and grinding; Artificial Saliva, product code LFD, intended for the relief of chronic and temporary xerostomia; Oral Wound Dressing, product code MGQ, intended to provide pain relief from aphthous ulcers, canker sores, and minor oral lesions; and Electrical Anesthesia, product code LWM, intended, through the application of electrical current, to provide analgesia or anesthesia during dental procedures. Also, on October 12, 2005, the committee will discuss and make recommendations regarding the over-the-counter (OTC) use of dental mouthguards.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:15AM-5:45PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel of the Medical Devices Advisory Committee

Meeting Date: 7/13/04-7/13/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a bone grafting material, which contains a wound-healing and revascularization agent, for treatment of dental osseous defects.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel

Meeting Date: 8/22/02-8/22/02

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a total temporomandibular joint prosthesis for reconstruction of the temporomandibular joint.

 

       
Location: HOL - GB Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel of the Medical Devices Advisory Committee

Meeting Date: 10/6/00-10/6/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a glenoid fossa prosthesis that is used alone to reconstruct the temporomandibular joint (TMJ). The committee will also discuss and make recommendations on the labeling for a total TMJ prosthesis.

 

       
Location: Corporate Blvd. Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDental Plaque Subcommittee

Meeting Date: 5/10/99-5/11/99

Meeting Details:

On May 10, 1999, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a total temporomandibular joint prosthesis, which consists of the glenoid fossa prosthesis and the mandibular condyle prosthesis, for reconstruction of the temporomandibular joint. On May 11, 1999, the committee will discuss, make recommendations, and vote on a PMA that includes both a total temporomandibular joint prosthesis and a glenoid fossa prosthesis that can be used alone without the mandibular condyle prosthesis to reconstruct the temporomandibular joint.

 

       
Location: Holiday Inn Gaithersburg Walker-Whetstone Rooms Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDental Plaque Subcommittee

Meeting Date: 12/2/98-12/3/98

Meeting Details:

On December 2, 1998, the committee will review the ingredients triclosan and triclosan and zinc citrate combination, review and vote on the combination of zinc chloride, sodium citrate, hydrogen peroxide, sodium lauryl sulfate. The Committee will discuss comment to the draft subcommittee report. On December 3, 1998, the committee will discuss comments to the draft report and adoption of the report.

 

       
Location: FDA Building Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDental Plaque Subcommittee

Meeting Date: 10/22/98-10/23/98

Meeting Details:

The Subcommittee will discuss the safety and efficacy of the combination of triclosan and zinc citrate and vote on the combination of zinc chloride, sodium citrate, hydrogen peroxide and sodium lauryl sulfate. The subcommittee will also discuss professional labeling for over-the-counter (OTC) antiplaque-antigingivitis drug products. The subcommittee will begin discussion, which will continue on October 23, 1998, of the elements of their recommendations concerning OTC antiplaque-antigingivitis drug products.

 

       
Location: Town Center Hotel Silver Spring, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDental Plaque Subcommittee

Meeting Date: 8/4/98-8/5/98

Meeting Details:

On August 4, 1998, the committee will discuss: (1) Previously unclassified devices for use in the diagnosis and/or treatment of temporomandibular joint dysfunction and oral-facial pain, (2) devices that FDA believes may fall within a present device classification and those devices that do not fall within a present device classification and thus remain unclassified, and (3) classification of the devices that remain unclassified. On August 5, 1998, the committee will continue discussion of the classification of devices for use in the diagnosis and/or treatment of temporomandibular joint dysfunction and oral-facial pain that remain unclassified. The list of those devices that FDA believes may fall within a present device classification and those devices that do not fall within a present device classification and thus remain unclassified will be placed on the FDA web site at here.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDental Plaque Subcommittee

Meeting Date: 5/27/98-5/29/98

Meeting Details:

On May 27, 1998, the subcommittee will discuss the safety and effectiveness of the combination of stannous pyrophosphate and zinc citrate, and continue the discussion of the effectiveness of the combination of hydrogen peroxide, sodium lauryl sulfate, sodium citrate and zinc chloride. The subcommittee will also discuss the safety and effectiveness of hexetidine, soluble pyrophosphate, nonsaponifiable fraction of corn oil, bromchlorophene and chlorhexidine digluconate. In addition the subcommittee will continue its discussion of final formulation testing. On May 28, 1998, the subcommittee will discuss labeling of over-the-counter antiplaque-antigingivitis drug products. On May 29, 1998, the subcommittee will discuss recommended therapeutic combinations for antiplaque-antigingivitis drug products.

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDental Drug Products Panel Plaque Subcommittee (Nonprescription Drugs)

Meeting Date: 5/8/97-5/9/97

Meeting Details:

On May 8, 1997, the subcommittee will discuss the safety of the individual ingredients menthol, thymol, methyl salicylate, and eucalyptol, and continue its discussion of the effectiveness of these ingredients. The subcommittee will also discuss zinc citrate. In addition, there will be continued discussion and/or summaries and voting on the ingredients cetylpyridinium chloride, Microdent, sodium lauryl sulfate, and C31G-Therasol . On May 9, 1997, the subcommittee will discuss the safety and effectiveness of the combination of hydrogen peroxide and povidone iodine, and the effectiveness of the combination of hydrogen peroxide, sodium citrate, zinc chloride, and sodium lauryl sulfate. There will also be continued discussion and/or summaries and voting on the ingredients xylitol, sodium bicarbonate, and the combination of hydrogen peroxide and sodium bicarbonate. In addition, the subcommittee will discuss general recommendations for antiplaque combination ingredients.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDental Drug Products Panel Plaque Subcommittee (Nonprescription Drugs)

Meeting Date: 12/16/96-12/17/96

Meeting Details:

On December 16, 1996, the subcommittee will discuss xylitol, C31G-Therasol, and the effectiveness of menthol, thymol, methyl salicylate, and eucalyptol. On December 17, 1996, the subcommittee will discuss microdent, and continue its discussion of sodium lauryl sulfate. In addition, the subcommittee will continue its discussion and vote on cetylpyridinium chloride, stannous fluoride, hydrogen peroxide, and sodium bicarbonate. If necessary, the subcommittee will continue its discussion of the effectiveness of menthol, thymol, methyl salicylate, and eucalyptol.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel of the Medical Devices Advisory Committee

Meeting Date: 12/4/95-12/5/95

Meeting Details:

On December 4, 1995, the subcommittee will discuss data and information submitted to support the safety and effectiveness of hydrogen peroxide, sodium bicarbonate, and a combination of these two ingredients for use in the prevention and/or treatment of dental plaque and gingivitis. On December 5, 1995, if necessary, the subcommittee will continue its discussion of hydrogen peroxide and sodium bicarbonate. In addition, it will begin to discuss data and information submitted to support the safety and effectiveness of sanguinaria extract for use in the prevention and/or treatment of dental plaque and gingivitis.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel Plaque Subcommittee (Nonprescription Drugs)

Meeting Date: 8/14/95-8/14/95

Meeting Details:

The subcommittee will continue with its discussion begun during the December 5 through 7, 1994, meeting, and continued at the April 10 through 12, 1995, meeting on developing general guidelines for determining the safety and effectiveness of antiplaque and antiplaque-related drug products. The subcommittee will also begin discussion on the safety and effectiveness of the ingredient cetylpyridinium chloride and a product containing an enzyme blend (amylase, protease, and lipase) with aloe vera for antiplaque and antiplaque-related uses.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDental Products Panel of the Medical Devices Advisory Committee

Meeting Date: 4/10/95-4/12/95

Meeting Details:

The subcommittee will continue with its discussion begun during the December 5 and 7, 1994, meeting on developing general guidelines for determining the safety and effectiveness of antiplaque and antiplaque-related drug products. The subcommittee will also begin discussion on the safety and effectiveness of the ingredients stannous fluoride, zinc citrate, peppermint oil, and sage oil for antiplaque and antiplaque-related uses.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Dental Products Panel Plaque Subcommittee & Dental Products Panel

Meeting Date: 12/6/94-12/6/94

Meeting Details:

N/A

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

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

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 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    
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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    
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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    
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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

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