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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 11/6/19-11/7/19

Meeting Details:

On November 6 and 7, 2019, the committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. Subject matter of the panel meeting will include potential methods and expert assessment of how to reduce EtO emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing of medical devices. The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes.

 

       
Location: Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 3/5/10-3/5/10

Meeting Details:

On March 5, 2010, the committee will discuss and make recommendations regarding clinical risks and benefits of post-market actions in response to insulin pump failures. Insulin pumps are intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin.

 

       
Location: Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 5/4/07-5/4/07

Meeting Details:

The committee will discuss and make recommendations on the scientific and clinical issues raised by the addition of antimicrobial agents to personal protective equipment (PPE). The PPE to be discussed are surgical masks/respirators, medical gloves, and surgical/isolation gowns.

 

       
Location: T B A Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 9/27/05-9/27/05

Meeting Details:

The committee will hear a presentation on FDA's Critical Path Initiative. Subsequently, the committee will discuss and make recommendations regarding general issues related to the model used for validation testing to support a claim of decontamination of potentially transmissible spongiform encephalopathy (TSE) contaminated surgical instruments.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 8/9/05-8/9/05

Meeting Details:

The committee will hear a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of post market study design. The committee will discuss and make recommendations on methods to assess the potential of disease transmission by multiple-use nozzle jet injectors (i.e., jet injectors for which the fluid path for the injection is used more than once). The discussion will include premarket testing recommendations to address this issue

 

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

Meeting Date: 8/6/95-9/7/95

Meeting Details:

The FDA reviewed performance standards.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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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    
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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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