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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products

Meeting Date: 11/6/15-11/6/15

Meeting Details:

The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., a subsidiary of Merck & Co., Inc., for the proposed indication of reversal of moderate or deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Devices Panel

Meeting Date: 2/20/14-2/20/14

Meeting Details:

On February 20, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the Inspire II Upper Airway Stimulator, sponsored by Inspire Medical Systems, Inc. The Inspire II Upper Airway Stimulator is a permanently implanted device intended to treat moderate to severe obstructive sleep apnea in patients who are not effectively treated by continuous positive airway pressure devices. The device stimulates the hypoglossal nerve synchronous with inspiration in order to contract the patient’s upper airway muscles and help maintain airway patency during sleep.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Devices Panel

Meeting Date: 10/28/09-10/28/09

Meeting Details:

On October 28, 2009, the committee will discuss, make recommendations, and vote on a premarket approval application for the Alair Bronchial Thermoplasty System sponsored by Asthmatx, Inc. The device is indicated for the treatment of severe persistent asthma in adults. FDA intends to make background material available to the public no later than 2 business days before the meeting.

 

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

Meeting Date: 5/28/09-5/28/09

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for the SEDASYSTM Computer-Assisted Personalized Sedation System sponsored by Ethicon Endo-Surgery, Inc. The device is indicated for the intravenous administration of 1% (10 milligrams/milliliters) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as identified by the American Society of Anesthesiologists Continuum of Depth of Sedation, in adult patients (American Society of Anesthesiology physical status I, II, or III) undergoing colonoscopy and esophagogastroduodenoscopy procedures.

 

       
Location: HOL-GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Devices Panel

Meeting Date: 12/5/08-12/5/08

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by Emphasys Medical, Inc., for the Emphasys Zephyr Endobronchial Valve System, which is intended to improve forced expiratory volume in the first second (FEV1) and 6-minute walk test distance in patients with severe heterogeneous emphysema who have received optimal medical management.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Devices Panel

Meeting Date: 6/12/08-6/12/08

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application for the ProGEL Surgical Sealant sponsored by NeoMend, Inc. The device is indicated to reinforce soft tissue where weakness exists as an adjunct to the standard procedure (sutures/staples) for closing intraoperative air leaks.

 

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

Meeting Date: 5/13/05-5/13/05

Meeting Details:

The committee will hear a presentation on FDA's 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. The committee will also discuss and make recommendations regarding general issues for pulse oximeters. The issues include the equivalence of reflectance sensor technology to transmissive sensor technology; validation recommendations for neonatal intended use; and over-the-counter (OTC) use of pulse oximeters.

 

       
Location: Hilton Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Panel

Meeting Date: 7/16/01-7/16/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a high-frequency ventilator used in the treatment of acute respiratory failure in adults.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthesiology & Respiratory Therapy Devices

Meeting Date: 12/18/98-12/18/98

Meeting Details:

The committee will discuss and make recommendations on general issues related to tracheal gas insufflation (TGI)devices used to provide part or all of the breathing gas for treatment of respiratory failure or respiratory insufficient The use of the TGI catheter, tube or lumen only for supply of fresh gas distinguishes TGI from common tracheal tubes and tracheostomy tubes, in which the gas flow alternates between inhalation and exhalation. Draft versions of five questions FDA will ask the committee to address are list below.

 

       
Location: Corporate Bldg. Conference room 020B 9200 Corp Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic with DSRM AdComm

Meeting Date: 5/22/18-5/22/18

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/12/18-6/12/18

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Meeting Details:

On June 12, 2018, the committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Cordis, Inc. for the INCRAFT AAA Stent Graft System, which is intended for the endovascular treatment of infra-renal abdominal aortic aneurysms in patients with appropriate anatomy. The INCRAFT device is being evaluated in the INSPIRATION study, a multicenter, prospective, non-randomized investigation. The study met its primary safety and effectiveness endpoints, but results also showed higher than anticipated rates of certain adverse events. The committee discussion will focus on how these events impact the long-term safety and effectiveness, as well as the benefit/risk profile of the device.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Devices Panel

Meeting Date: 6/14/18-6/14/18

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Meeting Details:

The committee will discuss, make recommendations and vote on information related to PneumRx, Inc.’s premarket approval application for the PNEUMRX ELEVAIR Endobronchial Coil System, which is a first of a kind implantable lung reduction coil for the proposed indication for use in patients with homogeneous and/or heterogeneous severe emphysema to improve quality of life, lung function, and exercise capacity.

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the ODAC

Meeting Date: 6/20/18-6/20/18

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Meeting Details:

The particular matter for this meeting will be review and discussion of a list of molecular targets for which evidence and/or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric cancers and a list of those targets deemed unlikely to be associated with the growth or progression of pediatric tumors. These lists are expected to fulfill the statutory obligation of the Food and Drug Administration Reauthorization Act (FDARA) and provide some guidance to industry in planning for initial Pediatric Study Plan submissions for new drug and/ or biologic products in development for cancer in accordance with the amended provisions of the Pediatric Research Equity Act. The committee will review and discuss considerations other than scientific relevance that FDA will include in decision making with respect to the need and timing of pediatric evaluation of specific new drug and biologic products. The committee will discuss possible criteria and mechanisms for the prioritization by sponsors and the clinical investigator community of select targeted new agents for pediatric evaluation especially in the setting of multiple same in class agents. Preliminary discussion will focus on approaches to coordination and collaboration for pediatric clinical investigations of new agents that might be pursued to efficiently accommodate international regulatory requirements and global pediatric product development. The open public hearing sessions are: Topic 1: Target List, Topic 2: FDARA Implementation, and Topic 3: Mechanisms to Assure Efficiency and to Enhance Global Coordination Through International Collaboration.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 5/17/18-5/17/18

Meeting Details:

On May 17, 2018, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant. Also on May 17, 2018, under Topic II, the committee will meet in open session to hear an overview of the research program in the Laboratory of Respiratory Viral Diseases (LRVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.On May 17, 2018, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant. Also on May 17, 2018, under Topic II, the committee will meet in open session to hear an overview of the research program in the Laboratory of Respiratory Viral Diseases (LRVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee and the EMDAC

Meeting Date: 5/11/18-5/11/18

Meeting Details:

On Friday, May 11, 2018, the PAC and EMDAC will meet to discuss drug development for the treatment of children with achondroplasia. The following topics should be considered for discussion: evidence required to establish dose-response, study design, study duration, intended population, and endpoints. In the open session, the committee does not intend to discuss any individual research programs.

 

       
Location: Tommy Douglas Conference Center 10000 New Hampshire Avenue Silver Spring, Maryland 20903 Related News Links: Not Available
Time: 12:00PM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

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

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: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastro and Pediatric AdComm

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

Meeting Details:

The committees will discuss new drug application (NDA) 209904, for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/2/18-5/2/18

Meeting Details:

The committee will discuss new drug application (NDA) 210303 for plazomicin, sponsored by Achaogen, Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections in adults.

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 5/1/18-5/1/18

Meeting Details:

The committee will discuss new drug application (NDA) 208627 for tecovirimat, sponsored by SIGA Technologies Inc., for the proposed indication of the treatment of smallpox disease caused by variola virus in adults and pediatric patients. This product was developed under the Animal Rule (21 CFR part 314, subpart I).

 

       
Location: DoubleTree by Hilton Hotel Bethesda Related News Links: Not Available
Time: 10:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsArthritis and DSRM AdComm

Meeting Date: 4/24/18-4/25/18

Meeting Details:

The committees will be asked to discuss supplemental new drug application (sNDA) 20998 for CELEBREX (celecoxib) capsules submitted by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial, a cardiovascular outcomes randomized controlled trial that compared celecoxib to ibuprofen and naproxen, and determine whether the findings of the trial change FDA’s current understanding of the safety of these three NSAIDs. In order to interpret some of the PRECISION findings, the committees will also consider the clinical implications of the drug interactions between each of these three NSAIDs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 4/23/18-4/23/18

Meeting Details:

The committee will discuss the new drug application (NDA) 207924, for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.

 

       
Location: FDA Meeting Room 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.

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