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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    
Materials:
   
       

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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    
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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 OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 5/27/21-1/27/21

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Meeting Details:

The committee will discuss the safety and efficacy of biologics license application (BLA) 761183, for teplizumab intravenous infusion, submitted by Provention Bio, Inc. The proposed indication is for the delay or prevention of clinical type 1 diabetes mellitus in at-risk (Stage 2) individuals.

 

       
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-5:30PM    
Materials:
   
       

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

Meeting Date: 6/3/21-6/4/21

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Meeting Details:

On June 3, 2021, during session I, the committee will discuss and make recommendations regarding the classification of topical refrigerants (vapocoolants), which are currently unclassified pre-amendment devices to Class II (general and special controls). During session II, the committee will discuss and make recommendations regarding the classification of acupressure devices, which are currently unclassified pre-amendment devices to Class I (general controls). During session III, the committee will discuss and make recommendations regarding the classification of electro-acupuncture stimulators, which are currently unclassified pre-amendment devices to Class II (general and special controls). On June 4, 2021, during session I, the committee will discuss and make recommendations regarding the classification of attention task performance recorders, which are currently unclassified pre-amendment devices to Class II (general and special controls). During session II, the committee will discuss and make recommendations regarding the classification of optical contour sensing devices, which are currently unclassified pre-amendment devices to class I (general controls). During session III, the committee will discuss and make recommendations regarding the classification of plunger-like joint manipulators, which are currently unclassified pre-amendment devices to Class II (general and special controls). 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-4:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsScience Advisory Board to the National Center for Toxicological Research 2021 Meeting

Meeting Date: 5/11/21-5/12/21

Meeting Details:

On May 11, 2021, the Science Advisory Board Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The Science Advisory Board will be presented with an overview of the Science Advisory Board Subcommittee Site Visit Report and a response to this review. The Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Food Safety and Applied Nutrition, Center for Tobacco Products, and the Office of Regulatory Affairs will each briefly discuss their specific research strategic needs and potential areas of collaboration. On May 12, 2021, there will be updates from the NCTR Research Divisions and a public comment session. Following an open discussion of all the information presented, the open session of the meeting will close so the Science Advisory Board members can discuss personnel issues at NCTR.

 

       
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-6:55PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the ODAC

Meeting Date: 5/11/21-5/12/21

Meeting Details:

On May 11, 2021, the subcommittee will discuss the development and successful implementation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) as a tool for eliciting the patient’s voice in oncology clinical trials to more accurately determine tolerability and toxicity of drugs under investigation. The subcommittee will also address the challenges of capturing this type of data across the age spectrum of the pediatric population and possible generalizability of data. It will consider approaches to address concerns about excluding the patient voice of young children deemed incapable of self-reporting. The subcommittee will also focus on approaches to investigators and commercial sponsors to use the Pediatric PRO-CTCAE in toxicity assessment moving forward. On May 12, 2021, the subcommittee will discuss real-world evidence (RWE) for regulatory use in pediatrics, real-world data (RWD) resources, and RWD and RWE to advance pediatric safety assessments of oncology drug products in children within the context of the FDA Framework for RWE. Potential data sources and publicly available platforms including those made possible through the development and implementation of the National Cancer Institute’s Childhood Cancer Data Initiative will be discussed. The potential for use of data sources to construct external controls to evaluate effectiveness of investigational products will be considered given the frequent dependence on single-arm studies due to extremely small study populations, now exaggerated by molecularly defined subtypes of the rare cancer types that occur in children.

 

       
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-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 5/6/21-5/6/21

Meeting Details:

The committee will discuss new drug application (NDA) 214487, for avacopan oral capsules, submitted by ChemoCentryx, Inc., for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis.

 

       
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-4:15PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 4/27/21-4/29/21

Meeting Details:

The committee will hear updates on certain supplemental biologics license applications (sBLAs) approved under 21 CFR 601.40 (subpart E, accelerated approval regulations) with confirmatory trial(s) that have not verified clinical benefit. These updates will provide information on: (1) the status and results of confirmatory clinical studies for a given indication; and (2) any ongoing and planned trials. Confirmatory studies are post-marketing studies to verify and describe the clinical benefit of a drug after it receives accelerated approval. Based on the updates provided, the committee will have a general discussion focused on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted. On April 27, 2021, the committee will receive updates on the following product: BLA 761034/S-018, for TECENTRIQ (atezolizumab), submitted by Genentech, Inc., indicated in combination with paclitaxel protein-bound for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells (IC) of any intensity covering = 1% of the tumor area), as determined by an FDA-approved test. On April 28, 2021, the committee will receive updates on the following products: (1) BLA 125514/S-017, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy; and (2) BLA 761034/S-001, trade name TECENTRIQ (atezolizumab), submitted by Genentech, Inc., indicated for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. On April 29, 2021, the committee will receive updates on the following products: (1) BLA 125514/S-024, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) =1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy; (2) BLA 125514/S-042, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; and (3) BLA 125554/S-041, trade name OPDIVO (nivolumab), submitted by Bristol-Myers Squibb Company, indicated as a single agent for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

 

       
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: 1:00PM-3:45PM    
Materials:
   
       

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