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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    
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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    
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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 OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 12/15/20-12/15/20

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 207620-S18, for the angiotensin receptor-neprilysin inhibitor, ENTRESTO (sacubitril and valsartan) tablets, submitted by Novartis Pharmaceuticals Corp., for the proposed indication of heart failure with preserved ejection fraction (HFpEF). 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 OptionsCardiovascular and Renal Drugs Advisory Committee

Meeting Date: 12/16/20-12/16/20

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Meeting Details:

The committee will discuss spironolactone for the proposed treatment of heart failure with preserved ejection fraction (HFpEF), a serious and often fatal condition for which no drug is approved to improve outcomes. The data supporting the new indication are post-hoc analyses of the National Heart, Lung, and Blood Institute (NHLBI) sponsored TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial, which nominally failed to meet its primary endpoint. Spironolactone is currently marketed in the US for the treatment of heart failure with reduced ejection fraction, hypertension, primary hyperaldosteronism, and for the management of edema. 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-1:30PM    
Materials:
   
       

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Recent Meetings

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

Meeting Date: 11/9/20-11/9/20

Meeting Details:

On November 9, 2020, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the VisAbility Micro Insert sponsored by Refocus Group, Inc. The proposed Indication for Use for the VisAbility Micro Insert, as stated in the PMA, is as follows: The VisAbility Micro Insert is indicated for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between the ages of 45 and 60 years of age, who have a manifest spherical equivalent between -0.75D and +0.50 D with less than or equal to 1.00D of refractive cylinder in both eyes, and require a minimum near correction of at least +1.25 D reading add. 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: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 11/6/20-11/6/20

Meeting Details:

On November 6, 2020, the committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease. 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-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic Drug Products AdComm and the DSaRM AdComm Meeting

Meeting Date: 11/2/20-11/2/20

Meeting Details:

The committees will discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Õlas Pharma, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term (not to exceed 3 days) management of acute post-operative pain severe enough to require an opioid analgesic and the prevention of opioid-induced nausea and vomiting in patients who are at risk for or have a history of nausea and vomiting. 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-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

Meeting Date: 10/27/20-10/27/20

Meeting Details:

On October 27, 2020, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Neovasc Reducer System sponsored by Neovasc, Inc. The proposed Indication for Use of the Neovasc Reducer System is for patients suffering from refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

 

       
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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Past Meetings

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