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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

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 1/16/20-1/16/20

Meeting Details:

The committee will discuss new drug application (NDA) 204803, bupivacaine extended-release solution for instillation, submitted by DURECT Corp., for the proposed indication of post-surgical analgesia. The committee will discuss whether the Applicant adequately demonstrated the safety and efficacy of bupivacaine extended-release solution for post-surgical analgesia and the appropriateness of the proposed patient populations. The committee will also be asked to discuss the approvability of this product.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products and DSRM AdComm

Meeting Date: 1/15/20-1/15/20

Meeting Details:

During the morning session, the committees will discuss new drug application (NDA) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

During the afternoon session, the committees will discuss NDA 209653, for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, as well as to discuss the overall risk-benefit profile of the product.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products and DSRM AdComm

Meeting Date: 1/14/20-1/14/20

Meeting Details:

The committees will discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

 

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

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Past Meetings

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