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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    
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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    
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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 OptionsNeurological Devices Panel of the Medical Devices

Meeting Date: 3/1/18-3/1/18

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Meeting Details:

On March 1, 2018, the committee will discuss, make recommendations, and advise FDA regarding the evaluation of clinical study data to support the safety and effectiveness of intracranial aneurysm treatment devices and factors that can affect clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. FDA is also convening this committee to seek expert opinion on the scientific and clinical considerations relating to the clinical trial design that may be relevant to the determination of safety and effectiveness for these devices.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 3/5/18-3/6/18

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Meeting Details:

Day 1 - The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. The Agency seeks input and recommendations on: how information in PLLR labeling is being perceived and used by health care providers and other stakeholders, factors that are critical to health care providers’ interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy. Day 2 - The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. The Agency seeks input and recommendations on: how information in PLLR labeling is being perceived and used by health care providers and other stakeholders, factors that are critical to health care providers’ interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 3/7/18-3/7/18

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Meeting Details:

The committee will discuss supplemental biologic license application (sBLA) 125557/S-013, for BLINCYTO (blinatumomab) injection for intravenous use, application submitted by Amgen, Inc. The proposed indication (use) for this product is for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 3/8/18-3/8/18

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203214, supplement 18, XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy.

 

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

Meeting Date: 3/22/18-3/23/18

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Meeting Details:

On Thursday, March 22, 2018, the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH) submitted by BioMarin Pharmaceutical Inc. The following elements of a phase 3 program should be considered for discussion: evidence required to establish dose-response, study design, e.g., placebo control, study duration, intended population, e.g., infants and toddlers and/or older children and adolescents, and endpoints that have a clinically meaningful impact on the patient’s functional or psychological well-being. On Friday, March 23, 2018, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. The Pediatric Advisory Committee will meet to discuss the following products (listed by FDA Center): 1) Center for Drug Evaluation and Research BANZEL, INTUNIV, LEXAPRO 2) Center for Devices and Radiological Health FLOURISH (HDE), ACTIVA (HDE), LIPOSORBER (HDE), IMPELLA RP SYSTEM (HDE)

 

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

Meeting Date: 5/10/18-5/10/18

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 210645, for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Anesthetic & Analgesic with DSRM AdComm

Meeting Date: 2/14/18-2/15/18

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees will also be asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved. The committee will discuss supplemental new drug application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia.

 

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

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Past Meetings

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