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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsHematology and Pathology Devices Panel

Meeting Date: 10/22/09-10/23/09

Meeting Details:

On October 22 and 23, 2009, the committee will discuss and make recommendations on public health issues related to the use of digital whole slide imaging systems to replace conventional light microscopy for diagnostic surgical pathology. In the scope of this meeting, digital pathology is defined as converting what can be observed by conventional light microscopy on histologic glass slides into digital whole slide images via digital scanners; viewing these images via a computer monitor to render pathologic diagnosis of the lesion of interest; and digitally archiving and retrieving these images. The committee will not be discussing computer-assisted image analysis or remote real-time microscopy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsHematology and Pathology Devices Panel

Meeting Date: 7/17/09-7/17/09

Meeting Details:

The committee will discuss and make recommendations on a (Clinical Laboratory Improvement Amendment) Waiver application for the HemoCue WBC Analyzer, sponsored by HemoCue, Inc. The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) counts in capillary or venous whole blood and can be used in clinical laboratories and at point-of-care settings.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsHematology and Pathology Devices Panel of the Medical Devices

Meeting Date: 7/18/08-7/18/08

Meeting Details:

The committee will discuss and make recommendations on issues relevant to the potential for automated differential cell counters being waived under the Clinical Laboratory Improvement Amendments of 1988. The discussion will include pre-analytical, analytical, and post-analytical issues associated with performing automated hematology complete blood counts and differentials in a waived setting.

 

       
Location: Hilton Washington DC North/Gaithersburg Salons A, B, and C, Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsHematology and Pathology Devices Panel of the Medical Devices Advisory

Meeting Date: 1/20/99-1/20/99

Meeting Details:

The Hematology and Pathology Devices Panel meeting scheduled for January 20, indicated that one agenda item for this panel was to establish a new classification for flow cytometers. In preparation for this meeting FDA has recognized that these devices have, in fact, been classified under an existing regulation, 21 CFR 864.5220. As a result, this agenda item will not be discussed as part of the meeting. This panel will,however, as stated in this FR, discuss,make recommendations, and vote on a petition for reclassification of Automated differential cell counters in (21CFR 864.5220(b)(2)(ClassIII)).

 

       
Location: Holiday Inn Gaithersburg Walker/Whetstone Salons Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsHematology & Pathology Devices

Meeting Date: 9/4/98-9/4/98

Meeting Details:

The Committee wil discuss, make recommendations, and vote on a premarket approval application (PMA) for an immunohistochemical device indicated for the detection of HER2 overexpression in breast cancer.

 

       
Location: Corporate Building Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/19-3/26/19

Broadcasting Live NOW

Meeting Details:

On March 25 and 26, 2019, the committee will discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) breast implant associated anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 4/8/19-4/8/19

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Meeting Details:

On April 8, 2019, the PAC will meet to discuss drug development for testosterone replacement therapy in male adolescents for conditions associated with a deficiency or absence of endogenous testosterone resulting from structural or genetic etiologies ("classic hypogonadism"). The following topics will be considered for discussion: diagnosing male adolescents with classic hypogonadism, evidence to establish efficacy and safety of testosterone replacement therapy in this population, study design, and feasibility considerations for such studies. The committee will not discuss any individual research programs.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 4/25/19-4/26/19

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Meeting Details:

Day 1 - On April 25th, The committee will discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis. Day 2 - On April 26th, The committee will discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only approved indication for bacitracin for intramuscular injection. The committee will also consider whether there are other uses for bacitracin for intramuscular injection that could be studied. FDA will present background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 5/8/19-5/8/19

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Meeting Details:

The committee will discuss new drug application (NDA) 202049, for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 3/21/19-3/21/19

Meeting Details:

On March 21, 2019, the committee will discuss and make recommendations on clinical information related to the de novo request for the NeuroAD Therapy System by Neuronix, Ltd. The NeuroAD Therapy System is intended to provide concurrent neurostimulation and cognitive training for the treatment of mild to moderate Alzheimer's dementia.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMicrobiology Devices Panel

Meeting Date: 3/8/19-3/8/19

Meeting Details:

On March 8, 2019, the committee will discuss and make recommendations regarding new or alternative approaches to the clinical study design and evaluation of devices detecting Human Papillomavirus (HPV) nucleic acid. These approaches will take into consideration scientific data generated since the approval of the first High Risk (HR) HPV screening device in 2003 as well as the effects of HPV vaccination on clinical studies of devices for HPV detection. Topics to be addressed at the meeting include clinical study design and comparator methods. Additionally, the committee will discuss potential changes to the HR HPV device indications for use considering continually evolving cervical cancer screening guidelines. The committee will provide expert feedback regarding the benefits and risks from the adoption of changes in each of the above topics and make recommendations for future HR HPV device evaluation strategies that are both scientifically rigorous and least burdensome.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/6/19-3/7/19

Meeting Details:

On March 6, 2019, 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 2019 to 2020 influenza season. Also under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Immunoregulation (LIR) and the Laboratory of Retroviruses (LR), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA. On March 7, 2019, under Topic III, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of Dengue Tetravalent Vaccine (Live, Attenuated) (DENGVAXIA) manufactured by Sanofi Pasteur.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:00AM-4:30AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 2/26/19-2/26/19

Meeting Details:

The committee will discuss new drug application (NDA) 212306 for selinexor tablets, application submitted by Karyopharm Therapeutics Inc. The proposed indication (use) for this product is in combination with dexamethasone, for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:30PM-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.

Live Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/19-3/26/19

Broadcasting Live NOW

Meeting Description:

On March 25 and 26, 2019, the committee will discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics: (1) breast implant associated anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians.


 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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