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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/19/19-6/20/19

Broadcasting Live NOW

Meeting Details:

On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices. FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of ODAC

Meeting Date: 6/20/19-6/20/19

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Meeting Details:

During the morning session, the particular matter for this meeting will be review and discussion of the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website: https://www.fda.gov/?AboutFDA/?CentersOffices/?OfficeofMedicalProductsandTobacco/?OCE/?ucm544641.htm. FDA is required by statute to review and update the previously approved and published lists. The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment. Planned introductory presentations will be on: (1) Cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors. During the afternoon session, information will be presented to gauge investigator interest in exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) ONC201, presentation by Oncoceutics Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 7/25/19-7/25/19

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 205832 for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm

Meeting Date: 7/31/19-7/31/19

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Meeting Details:

The committee will discuss new drug application (NDA) 209500, lumateperone tosylate capsules for oral administration, submitted by Intra-Cellular Therapies, Inc., for the treatment of schizophrenia.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint DSRM & Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 6/11/19-6/12/19

Meeting Details:

FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. We are also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients. FDA frequently hears from patients and healthcare providers that higher dose opioid analgesics continue to be a unique and necessary part of effective pain management for some patients. FDA is also cognizant of serious safety concerns associated with both higher strengths and higher daily doses of opioid analgesics, both in patients and in others who may access these drugs. Higher strength products may be more harmful in cases of accidental exposure and overdose and may also be more sought out for misuse and abuse. Along with a number of other factors, a higher daily opioid dose is associated with greater risk of overdose. Concerns have also been raised that higher dose opioid regimens may carry a higher risk of addiction, although robust evidence for a causal relationship is lacking. There is a strong association between higher opioid dose and duration/persistence of opioid analgesic therapy and assessing temporal relationships and independent effects of opioid dose and duration on the risks of both addiction and overdose is challenging. In addition, FDA acknowledges the complex and evolving landscape of the opioid epidemic, with myriad Federal, State, local, and payer efforts to encourage more judicious prescribing of opioid analgesics, and the growing threat of highly lethal illicit opioids. To better understand both the clinical utility and harms of higher dose opioid analgesics in the current environment, and to discuss the advantages and disadvantages of various potential risk management strategies, FDA brings these issues to an advisory committee to seek input and advice from the clinical, patient, public health, and research communities. In particular, FDA seeks to discuss: (1) The current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 6/6/19-6/6/19

Meeting Details:

The committee will discuss new drug application (NDA) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis (TB).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/30/19-5/31/19

Meeting Details:

On May 30, 2019, the committee will discuss and make recommendations regarding the reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls). On May 31, 2019, the committee will discuss and make recommendations regarding the reclassification of certain absorbable hemostatic agents from Class III to Class II (special controls).

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-5:00PM    
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 OptionsCirculatory System Devices Panel

Meeting Date: 6/19/19-6/20/19

Broadcasting Live NOW

Meeting Description:

On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices. FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings.


 

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

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