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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    
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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    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Gastrointestinal & DSRM AdComm - Sponsor: Sloan Pharma

Meeting Date: 10/17/18-10/17/18

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Meeting Details:

The committees will discuss supplemental new drug application (sNDA) 021200, supplement 015, for ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.[agrave].r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Sponsor: Shire

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

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Meeting Details:

The committee will discuss new drug application (NDA) 210166 for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 10/24/18-10/25/18

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Meeting Details:

Agenda: On both days, the committee will discuss the ``Guidance for Industry: Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes' (https://www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf), and the cardiovascular risk assessment of drugs and biologics for the treatment of type 2 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Alkermes Inc.

Meeting Date: 11/1/18-11/1/18

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Meeting Details:

The committees will discuss efficacy, safety and risk-benefit profile of new drug application (NDA) 210417 for buprenorphine and samidorphan sublingual tablets, submitted by Alkermes, Inc., for adjunctive treatment of major depressive disorder.

 

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

Meeting Date: 11/15/18-11/15/18

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Meeting Details:

On November 15, 2018, the Committee will discuss and make recommendations on the topic “Connected and Empowered Patients: e-Platforms Potentially Expanding the Definition of Scientific Evidence.” The recommendations will address how FDA can leverage patient-driven platforms, such as social media and registries, to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. Social media and other web platform enablers are facilitating the growth of virtual patient communities. Increasingly, patients and health care consumers are using these platforms to share their health experiences and seek information from other patients and consumers, rather than their health care providers alone. Novel approaches and methodologies are being used to tap into some of these platforms as potentially rich sources of patient-generated health data, which could be used as relevant and reliable real-world evidence. This meeting will help advance FDA’s objective to assure the needs, experiences, and perspectives of patients are included as part of FDA’s deliberations involving the regulation of medical devices and their use by patients. For this meeting, FDA is seeking input from the Committee and the public on whether and how FDA can harness the emerging potential of these patient platforms to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. In addition, FDA is seeking recommendations from the Committee on ways to leverage these platforms to disseminate as well as potentially collect and evaluate health information to and from patients and consumers.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm - Sponsor: AcelRX

Meeting Date: 10/12/18-10/12/18

Meeting Details:

The committee will be asked to discuss new drug application (NDA) 209128, sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The committee will also be asked to discuss risk- benefit considerations and whether this product should be approved.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm - Sponsor: Trevena Inc.

Meeting Date: 10/11/18-10/11/18

Meeting Details:

The committee will be asked to discuss new drug application (NDA) 210730, for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee will also be asked to discuss the efficacy and safety data and benefit-risk considerations.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm - Sponsor: Genentech & Celltrion

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

Meeting Details:

The committee will discuss biologics license application 761088 for CT-P10, a proposed biosimilar to Genentech, Inc.'s RITUXAN (rituximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are for the treatment of adult patients with (1) relapsed or refractory, low-grade or follicular, CD20-positive, B- cell Non-Hodgkin's Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to CT-P10 in combination with chemotherapy, as single- agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel - Sponsor: Sequent Medical, Inc.

Meeting Date: 9/27/18-9/27/18

Meeting Details:

On September 27, 2018, the Committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Sequent Medical, Inc. for the Woven Endobridge (WEB) Aneurysm Embolization System, which is intended to treat wide-neck intracranial aneurysms arising or located at a vessel bifurcation. The WEB device is being evaluated in the WEB Intrasaccular Therapy Study (WEB-IT): a multicenter, prospective, non-randomized investigation. The Committee will be asked to review the clinical data from the WEB-IT study to help the Agency assess the safety and effectiveness of the device for the proposed indications for use.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 9/20/18-9/20/18

Meeting Details:

The meeting will focus on two topics related to the Office of Pharmaceutical Quality’s priority of promoting the availability of better medicine. During the morning session, the committee will discuss the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. FDA will seek input on the potential enhancement of a submission format consistent with KASA to improve the efficiency and consistency of regulatory quality assessment. During the afternoon session, the committee will discuss in-vitro/in-vivo relationship standards, and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/20/18-9/20/18

Meeting Details:

On Thursday, September 20, 2018, the PAC will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155). The PAC will meet to discuss the following Center for Drug Evaluation and Research products: INTUNIV LEXAPRO The FDA will provide general safety updates including updates on the following topics without vote by the committee: Overview of FAERS and lack of efficacy; Generic drug approval process; and discussion on trade versus generic drugs; exceptions; Summary of FDA completed review of pediatric safety issues and updated labeling changes for Exjade (deferasirox); Update labeling change for inhaled corticosteroid long-acting ß-2 agonists (ICS/LABAs); Safety labeling for gadolinium.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Past Meetings

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