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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    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 7/25/18-7/25/18

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Meeting Details:

The committee will discuss supplemental biologics license application (sBLA) 125526 for mepolizumab for injection, submitted by GlaxoSmithKline for add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 7/26/18-7/26/18

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Meeting Details:

The committee will discuss new drug application (NDA) 210607, tafenoquine tablet, 100 milligram (mg), sponsored by 60 Degrees Pharmaceuticals, LLC, for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint DSRM and Anesthetic & Analgesic Drugs AdComm

Meeting Date: 8/3/18-8/3/18

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Meeting Details:

The committees will discuss results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS), approved in December 2011. The TIRF REMS requires that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified, that pharmacies that dispense TIRF medicines for inpatient and outpatient use are specially certified, and that completion of the prescriber-patient agreement form occurs prior to dispensing TIRF medicines for outpatient use. The Agency will seek the committees’ assessment as to whether this REMS with elements to assure safe use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. The Agency will also seek the committees’ input on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met. Comments from the public can be submitted to the docket (see PUBLIC PARTICIPATION INFORMATION) on a broad evaluation of the TIRF REMS and whether any aspect of the TIRF REMS should be modified as well as any proposed modifications.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 8/7/18-8/7/18

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Meeting Details:

The committee will discuss new drug application (NDA) 207356, amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 8/18/18-8/18/18

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Meeting Details:

The committee will discuss new drug applications 209816, for omadacycline tablets, and 209817, for omadacycline injection, sponsored by Paratek Pharmaceuticals, Inc., for the proposed indications for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-1:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 7/12/18-7/12/18

Meeting Details:

The committee will discuss new drug application (NDA) 210795, tafenoquine tablet, 150 milligram, sponsored by GlaxoSmithKline Intellectual Property Development Ltd., England, for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax malaria.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 6/26/18-6/26/18

Meeting Details:

The committees will discuss new drug application 022324, oxycodone extended-release capsules, submitted by Pain Therapeutics, with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have abuse-deterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse. Closed Committee Deliberations: On June 26, 2018, from 8 a.m. to 9:30 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational opioid formulation with properties designed to deter abuse.

 

       
Location: DoubleTree Bethesda, MD Related News Links: Not Available
Time: 9:30AM-5:00PM    
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Past Meetings

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