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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 10/24/12-10/24/12

Meeting Details:

On October 24, 2012, the committee will discuss, make recommendations, and vote on a premarket approval application supplement to expand the indications for use of the Selenia Dimensions 3D System with C-View Software Module, sponsored by Hologic, Inc. The Selenia Dimensions 3D System is currently approved for breast cancer screening and diagnosis. The screening exam can consist of field digital mammography (FFDM) alone or the combination of FFDM with digital breast tomosynthesis (DBT). The new C-View Software Module can generate synthetic 2D images from the DBT data. Hologic requests to expand the indications for use to allow the combination of DBT with synthetic 2D images to be used as another exam option for breast cancer screening.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 4/11/12-4/12/12

Meeting Details:

On April 11, 2012, the committee will discuss, make recommendations, and vote on information related to a premarket approval application for the Automated Breast Ultrasound (ABUS) scanning device, sponsored by U–Systems, Inc. The ABUS scanning device is intended to increase breast cancer detection in asymptomatic dense-breasted women following a negative screening mammogram. On April 12, 2012, during session I, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class III devices. On July 18, 1995 (60 FR 36639), FDA published a Final Rule that misbranded breast transilluminators and effectively placed them in class III based on the recommendation of the Obstetrics and Gynecology Devices Panel, which concluded there were no published studies or clinical data demonstrating the safety and effectiveness of this device. The committee discussion will include a review of the present literature to assess the current knowledge of breast transilluminators and determine if sufficient safety and effectiveness data are available to support reclassification of breast transilluminators.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 9/24/10-9/24/10

Meeting Details:

On September 24, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic, Inc. The Selenia C Digital Breast Tomosynthesis System is intended for use in the same clinical applications as traditional mammographic systems.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 3/4/08-3/5/08

Meeting Details:

On March 4 and 5, 2008, the committee intends to discuss and make recommendations about computer aided detection and diagnosis (CAD) devices for radiological images, e.g., mammograms, chest x-rays, and computed tomography (CT) images of the lungs or colon. There will be a general discussion focusing on the general methodologies for CAD, including how CAD devices are used in clinical decision-making, how the devices are tested, and the information needed to properly assess their safety and effectiveness. The general discussion will be followed by specific discussions related to mammography CAD devices, colon CAD devices, and lung CAD devices. These discussions will include how the different types of CAD devices are used and the literature published regarding these devices, with focus on testing issues related to the different devices.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 5/23/06-5/23/06

Meeting Details:

The committee will hear a presentation explaining FDA's Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. Subsequently, FDA will present key points for the committee to consider for the reclassification of full field digital mammography (FFDM) systems from Class III to Class II devices. The committee will discuss and make recommendations on the reclassification of FFDMs.

 

       
Location: Holiday Inn Related News Links: Not Available
Time: 9:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 2/3/04-2/3/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a computer aided detection device that identifies nodules in CT images of the lung.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 12/10/02-12/10/02

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device that produces a computerized thermal image of the breast of women recommended for biopsy.

 

       
Location: HOL - Gaithersburg, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 3/5/01-3/5/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a computer-aided detection (CAD) device for identifying regions of interest in chest radiographs.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 11/6/00-11/6/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an embolic radiation therapy device.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 12/16/99-12/16/99

Meeting Details:

On December 16, 1999, the committee will discuss, make recommendations, and vote on a premarket approval application for a digital mammography device.

 

       
Location: DoubleTree Hotel Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 5/17/99-5/17/99

Meeting Details:

The committee will discuss bone strength assessment, with focus on the use of gender-specific and race-specific databases in assessing fracture risk and their applicability to bone densitometry and sonometry device labeling.

 

       
Location: Corporate Bldg. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 8/17/98-8/18/98

Meeting Details:

To discuss, make recommendations and vote on premarket approval applications for a caries detection device (P980025) and a trans-spectral impedance (breast) scanner (P970033). To discuss and make suggestions for changes to the existing 510(k) guidance document for digital mammography devices.

 

       
Location: Unknown Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Devices Panel

Meeting Date: 5/11/98-5/11/98

Meeting Details:

To discuss and make recommendations and vote on a premarket approval application (P970058) for a computer aided detection system for screening mammograms, and to hold a closed briefing session.

 

       
Location: Unknown Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadiological Panel

Meeting Date: 2/24/97-2/24/97

Meeting Details:

The committee discussed Optison (FS069) for the use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel - - Sponsor: Impulse Dynamics, Inc.

Meeting Date: 12/4/18-12/5/18

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Meeting Details:

On December 4, 2018, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the OPTIMIZER SMART Implantable Pulse Generator device, sponsored by Impulse Dynamics (USA), Inc. This first-of-a-kind device is indicated to provide cardiac contractility modulation for class III heart failure patients who are not responding to optimal medical therapy. On December 5, 2018, the committee will discuss and make recommendations regarding issues relating to the emergence of medical devices, which aim to treat hypertension. Currently, clinical studies to evaluate the safety and effectiveness of these devices are progressing. FDA requests panel input regarding the potential indications and labeling for devices intended to treat hypertension and optimal study designs needed to evaluate the potential benefits and risks while considering issues such as medication compliance, patient perspective, and appropriate study controls.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic &Analgesic with DSRM AdComm

Meeting Date: 12/17/18-12/18/18

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Meeting Details:

The committees will provide input and advice on strategies to increase the availability of naloxone products intended for use in the community. The committees will be asked to consider various options for increasing access to naloxone, weighing logistical, economic, and harm reduction aspects and whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death. Because of the potential, significant costs and burdens that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages), the committees will also be asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some prescription opioid patients.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement AdComm

Meeting Date: 11/15/18-11/15/18

Meeting Details:

On November 15, 2018, the Committee will discuss and make recommendations on the topic “Connected and Empowered Patients: e-Platforms Potentially Expanding the Definition of Scientific Evidence.” The recommendations will address how FDA can leverage patient-driven platforms, such as social media and registries, to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. Social media and other web platform enablers are facilitating the growth of virtual patient communities. Increasingly, patients and health care consumers are using these platforms to share their health experiences and seek information from other patients and consumers, rather than their health care providers alone. Novel approaches and methodologies are being used to tap into some of these platforms as potentially rich sources of patient-generated health data, which could be used as relevant and reliable real-world evidence. This meeting will help advance FDA’s objective to assure the needs, experiences, and perspectives of patients are included as part of FDA’s deliberations involving the regulation of medical devices and their use by patients. For this meeting, FDA is seeking input from the Committee and the public on whether and how FDA can harness the emerging potential of these patient platforms to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. In addition, FDA is seeking recommendations from the Committee on ways to leverage these platforms to disseminate as well as potentially collect and evaluate health information to and from patients and consumers.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm

Meeting Date: 11/15/18-11/15/18

Meeting Details:

The committee will discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. The committee will be asked to comment on the trial design and endpoints of these studies and how to determine the clinical relevance of the results.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic with DSRM AdComm - Sponsor: SpecGX Inc.

Meeting Date: 11/14/18-11/14/18

Meeting Details:

The committees will discuss new drug application (NDA) 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc., for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will also be asked to determine whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Sage Therapeutics

Meeting Date: 11/2/18-11/2/18

Meeting Details:

The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 211371, brexanolone 5 mg/mL intravenous injection, submitted by Sage Therapeutics, for the proposed indication of postpartum depression.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Alkermes Inc.

Meeting Date: 11/1/18-11/1/18

Meeting Details:

The committees will discuss efficacy, safety and risk-benefit profile of new drug application (NDA) 210417 for buprenorphine and samidorphan sublingual tablets, submitted by Alkermes, Inc., for adjunctive treatment of major depressive disorder.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 10/24/18-10/25/18

Meeting Details:

Agenda: On both days, the committee will discuss the ``Guidance for Industry: Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes' (https://www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf), and the cardiovascular risk assessment of drugs and biologics for the treatment of type 2 diabetes mellitus.

 

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

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Past Meetings

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