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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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 OptionsBone, Reproductive and Urologic Drugs Advisory Committee

Meeting Date: 12/6/16-12/6/16

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Meeting Details:

The committee will discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis.

 

       
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 OptionsBlood Products Advisory Committee Meeting

Meeting Date: 11/17/16-11/18/16

Meeting Details:

On the morning of November 17, 2016, the Committee will meet in open session to discuss strategies to manage iron deficiency associated with blood donation. The Committee will also discuss proposed procedures for assuring donor safety for collections of blood from female donors with hemoglobin values of 12.0-12.4g/dL or a hematocrit value between 36 and 38. In the afternoon, the Committee will meet in open session to discuss adverse reactions related to blood donation in teenage (16 to 18 years) donors, and the effectiveness of several mitigation measures. On November 18, 2016, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States. Following the informational session, the Committee will hear presentations on the following topics: (1) The Transfusion Transmissible Infections Monitoring System; (2) a summary of the FDA workshop on new methods to predict the immunogenicity of therapeutic coagulation proteins; and (3) a summary of the FDA workshop on preclinical evaluation of red blood cells for transfusion.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 11/9/16-11/10/16

Meeting Details:

On November 9, 2016, during session one, the committee will discuss and make recommendations regarding the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)). A nucleic acid-based in vitro diagnostic device for the quantitation of CMV viral load, within the context of transplant patient management, is a post-amendment device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act )(21 U.S.C. 360c(f)(1). To date, the following product code has been established for CMV viral load devices: PAB (CMV DNA Quantitative Assay). During session two, the committee will discuss and make recommendations regarding the appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus, BK virus, JC virus, Human Herpesvirus 6, and Adenovirus infections. FDA is seeking expert recommendations to assess the potential risks and benefits of these devices when used in patients following solid-organ or stem cell transplantation.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting of the Antimicrobial Drugs Advisory Committee

Meeting Date: 11/4/16-11/4/16

Meeting Details:

The committee will discuss new drug applications 209006 and 209007, solithromycin capsules and solithromycin for injection, sponsored by Cempra Pharmaceuticals, Inc., respectively for the proposed indication of treatment of community-acquired bacterial pneumonia (CABP).

 

       
Location: tbd Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Past Meetings

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