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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 OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 9/30/21-9/30/21

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Meeting Details:

Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, 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 2021 to 2022 southern hemisphere influenza season. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 8:30AM-3:40PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPatient Engagement Advisory Committee

Meeting Date: 10/6/21-10/6/21

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Meeting Details:

On October 6, 2021, the committee will discuss and make recommendations on the topic ‘‘Medical Device Recalls.’’ Once a medical device is available in the U.S. marketplace and in widespread use, unforeseen problems can sometimes lead to a recall. When a device is defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public. A company may recall a device after discovering a problem on its own, or after FDA raises concerns. In rare cases, FDA may require a company to recall a device. When a device is recalled, FDA reviews the company’s strategy for resolving the problem by assessing the relative degree of risk associated with the product and making sure the strategy effectively resolves the problem with the device. FDA provides transparency and communicates information when the public needs to be alerted to a serious hazard, as well as once the recall has been appropriately resolved. The recommendations provided by the committee will address factors FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication. The committee will also consider concerns patients have about changes to their device in response to a recall and will discuss ways patient perspectives could be incorporated in FDA and industry benefit-risk decision making, as well as the healthcare provider and patient decision-making process related to a recalled medical device, including implanted devices. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 10/7/21-10/7/21

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Meeting Details:

The committee will discuss new drug application (NDA) 215596, for maribavir oral tablets, submitted by Takeda Pharmaceuticals USA, Inc., for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel of the MDAC

Meeting Date: 10/20/21-10/20/21

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Meeting Details:

On October 20, 2021, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SurgiMend PRS Acellular Bovine Dermal Matrix (SurgiMend PRS ABDM) by Integra LifeSciences Corporation. The proposed Indication for Use, as stated in the PMA, is as follows: SurgiMend PRS Acellular Bovine Dermal Matrix is intended for use as soft tissue support in post-mastectomy breast reconstruction. SurgiMend PRS Acellular Bovine Dermal Matrix is specifically indicated for immediate, two-stage, submuscular, alloplastic breast reconstruction. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 10/28/21-10/28/21

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Meeting Details:

The committee will discuss new drug application (NDA) 214383, PEPAXTO (melphalan flufenamide) for injection submitted by Oncopeptides AB, approved under 21 CFR 314.500 (subpart H, accelerated approval regulations), in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

Meeting Date: 11/2/21-11/3/21

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Meeting Details:

On November 2, 2021, the committee will discuss and make recommendations on information about the benefit-risk profile of the Endologix AFX endovascular graft system with regards to the risk of Type III endoleaks. FDA requests panel input regarding the totality of data collected on AFX devices and whether further actions are necessary. On November 3, 2021, the committee will discuss and make recommendations on the continued safety and effectiveness of endovascular stent grafts and how to strengthen real-world data collection on long-term performance of the devices, both for currently marketed devices and for future technologies. FDA intends to request panel input on the clinical outcomes that are most relevant to capture in the real world, along with their frequency and duration. Additionally, FDA intends to seek input on data collection platforms, and how to incentivize and optimize real world data collection. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 11/4/21-11/4/21

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Meeting Details:

The committee will discuss new drug application (NDA) 214812, for carbetocin nasal spray, submitted by Levo Therapeutics, Inc., for the proposed treatment of hyperphagia, anxiety, and distress behaviors associated with Prader-Willi syndrome. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 9/17/21-9/17/21

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 8:30AM-3:45PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee Meeting Announcement

Meeting Date: 9/17/21-9/17/21

Meeting Details:

On September 17, 2021, the Pediatric Advisory Committee (PAC) will meet to discuss the 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 products listed by FDA Center: Center for Devices and Radiological Health a. FLOURISH Pediatric Esophageal Atresia Device (humanitarian device exemption) The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies AdComm

Meeting Date: 9/2/21-9/3/21

Meeting Details:

The CTGTAC committee will meet in open session on both days to discuss the toxicity risks of adeno-associated virus (AAV) vector-based gene therapy products. The discussion topics include oncogenicity risks due to vector genome integration and safety issues identified during preclinical and/or clinical evaluation. On September 2, 2021, in the morning, under session 1, CTGTAC committee will meet to discuss and make recommendations on vector integration and oncogenicity risks. In the afternoon, under session 2, the committee will discuss and make recommendations on hepatotoxicity issues. On September 3, 2021, in the morning, under session 3, the committee will meet to discuss and make recommendations on thrombotic microangiopathy issues. In the afternoon, under session 4, the committee will discuss and make recommendations on non-clinical findings of neurotoxicity, especially related to the dorsal root ganglion toxicity issues. Also, in the afternoon, under session 5, the committee will discuss and make recommendations on clinical findings of neurotoxicity, based on brain MRI studies. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-6:00PM    
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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