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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNational Mammography Quality Assurance Advisory Committee

Meeting Date: 4/19/04-4/19/04

Meeting Details:

The committee will discuss the following issues: (1) mechanisms to reduce the regulatory and inspection burden on facilities; (2) whether mammographic images obtained from reconstructed compressed digital data (lossless or lossy data compression) can be used for primary interpretation or storage; (3) whether images obtained from digitized film-screen mammograms can be used for primary interpretation or storage; and (4) revisions to MQSA compliance guidance. The committee will also receive updates on recently approved alternative standards, full field digital mammography accreditation and certification, the inspection demonstration program, the status of MQSA reauthorization, and the new post inspection enforcement strategy.

 

       
Location: Holiday Inn Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNational Mammography Quality Assurance Advisory Committee

Meeting Date: 11/2/98-11/3/98

Meeting Details:

On November 2, 1998, the committee will discuss the proposed Mammography Quality Standards Act (MQSA) compliance guidance under the final regulations. On November 3, 1998, the committee will receive updates on the issues of States as Certifying Bodies under MQSA, Congressional Reauthorization of MQSA, and Voluntary Stereotactic Accreditation Programs.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNational Mammography Quality Assurance

Meeting Date: 5/4/98-5/5/98

Meeting Details:

On May 4, the committee will discuss the proposed Mammography Quality Standards Act (MQSA) inspection procedures under the final regulations. On May 5, the committee will discuss the issue of collimation of the x-ray field as it relates to mammography and receive updates on the issues of States as certifying bodies under MQSA, Interventional Mammography, and Voluntary Stereotactic Accreditation Programs.

 

       
Location: Gaithersburg Hilton, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 8/13/20-8/13/20

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Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On August 13, 2020, the committee will discuss biologics license application (BLA) 125706, for remestemcel-L (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion), submitted by Mesoblast, Inc. The proposed indication (use) for this product is for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. The morning session will discuss issues related to the characterization and critical quality attributes of remestemcel-L as they relate to clinical effectiveness. The afternoon session will discuss results from clinical trials included in BLA 125706.

 

       
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-5:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee Meeting

Meeting Date: 7/15/20-1/15/20

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 15, 2020, the committee will be asked to discuss new drug application (NDA) 22231, terlipressin, lyophilized powder for solution for injection,submitted by Mallinckrodt Pharmaceuticals, for the proposed indication of treatment of hepatorenal syndrome Type 1.

 

       
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 OptionsOncologic Drugs Advisory Committee

Meeting Date: 7/14/20-7/14/20

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 14, 2020, the committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

 

       
Location: TelCon | 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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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 7/14/20-7/14/20

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 14, 2020, the committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

 

       
Location: TelCon | 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-1:30AM    
Materials:
   
       

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Past Meetings

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