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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthesiology and Respiratory Therapy Devices Panel of the MDAC

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

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: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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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    
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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    
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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    
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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    
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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    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 4/2/20-4/3/20

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Meeting Details:

On April 2, 2020, in the morning, the BPAC will meet in open session to discuss and make recommendations on strategies to reduce the risk of Zika virus (ZIKV) transmission by blood and blood components. The committee will discuss whether universal testing of blood donations for ZIKV is an appropriate strategy considering the decline of ZIKV cases in the U.S. and worldwide. In the afternoon, the committee will meet in open session to hear an update on the Transfusion Transmissible Infections Monitoring System (TTIMS). Sponsored by the FDA, National Heart, Lung and Blood Institute and Office of the Assistant Secretary for Health, TTIMS collects incidence, prevalence and risk factor data for certain transfusion-transmitted infections, including HIV, in U.S. blood donations. On April 3, 2020, the committee will meet in open session to discuss and make recommendations on testing for hepatitis B surface antigen (HBsAg) in blood donations. The committee will discuss whether testing for HBsAg can be discontinued considering the sensitivity of hepatitis B virus nucleic acid testing and hepatitis B anti-core testing of blood donations in the U.S.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-3:45PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Advisory Committee

Meeting Date: 4/21/20-4/21/20

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 209482/S-008, for TRELEGY ELLIPTA, a fixed dose combination (fluticasone furoate, umeclidinium, and vilanterol inhalation powder (FF/UMEC/VI)) oral inhalation, submitted by GlaxoSmithKline, for the following proposed labeling claim: Reduction in all-cause mortality in patients with chronic obstructive pulmonary disease (COPD). The focus of the discussion will be on the efficacy data submitted to support the proposed labeling claim, including the results from the Informing the Pathway of COPD Treatment (IMPACT) trial and the influence of inhaled corticosteroids (ICS) withdrawal on the results.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs Advisory Committee

Meeting Date: 4/23/20-4/23/20

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Meeting Details:

The committee will discuss new drug application 212123, flortaucipir F18 intravenous injection, a radioactive diagnostic agent, submitted by Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles of Alzheimer’s disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel of the Medical Devices AdComm

Meeting Date: 4/23/20-4/24/20

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Meeting Details:

On April 23, 2020, during session I, the committee will discuss and make recommendations regarding the classification of facet screws systems, which are currently unclassified pre-amendment devices to class II (general and special controls). During session II, the committee will discuss and make recommendations regarding the reclassification of noninvasive bone growth stimulators, which are currently post-amendment devices from class III (general controls and premarket approval) to class II (general and special controls). On April 24, 2020, the committee will discuss and make recommendations regarding the classification of three devices, which are currently unclassified pre-amendment devices to class II (general and special controls). The committee, during session I, will discuss semiconstrained toe (metatarsophalangeal) joint prostheses; during session II, will discuss intracompartmental pressure monitors; and during session III, will discuss intra-abdominal pressure monitoring devices.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/29/20-4/29/20

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Meeting Details:

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Location: tbd Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAllergenic Products Advisory Committee

Meeting Date: 5/15/20-5/15/20

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Meeting Details:

The Center for Biologics Evaluation and Research's (CBER) Allergenic Products Advisory Committee (APAC) will meet in open session to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A for treatment of patients 4 through 11 years old with a confirmed diagnosis of peanut allergy.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-3:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee

Meeting Date: 3/11/20-3/11/20

Meeting Details:

In the Agency's document entitled “Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information” (December 7, 2018, 83 FR 63168) (Docket No. FDA-2018-N-3458), FDA sought input on the current use of over-the-counter antiseptics in the food handler setting and the recommended testing criteria to establish the safety and effectiveness of these products. Now that the comment period has closed, FDA plans to hold an advisory committee meeting to review the information submitted and discuss its key points.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/20-3/4/20

Meeting Details:

On March 4, 2020, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 influenza season. Also, on March 4, 2020, under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Respiratory and Special Pathogens (LRSP), Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:30AM-5:10PM    
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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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