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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    
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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    
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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 OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 12/7/17-12/7/17

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Meeting Details:

The committee will discuss appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The committee will also discuss whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

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

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Meeting Details:

On December 12, 2017, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Barricaid Anular Closure Device by Intrinsic Therapeutics. The proposed Indication for Use, as stated in the PMA, is as follows: The Barricaid is intended to be implanted following a limited discectomy, to prevent reherniation and the recurrence of pain or dysfunction. The Barricaid is indicated for patients with radiculopathy (with or without back pain), a posterior or posterolateral herniation, characterized by radiographic confirmation of neural compression using magnetic resonance imaging, and a large anular defect (e.g., between 4-6 mm tall and between 6-12 mm wide) post discectomy, at one level between L4 and S1.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 11/16/17-11/16/17

Meeting Details:

The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (=18 years of age) with respiratory bacterial pathogens.

 

       
Location: tbd Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 11/7/17-11/7/17

Meeting Details:

On November 7, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs AdComm and the DSRM AdComm

Meeting Date: 11/1/17-11/1/17

Meeting Details:

The committees will discuss new drug application (NDA) 210136, buprenorphine subcutaneous injection, submitted by Braeburn Pharmaceuticals, Inc., for treatment of opioid dependence.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs AdComm and the DSRM AdComm

Meeting Date: 10/31/17-10/31/17

Meeting Details:

The committees will discuss new drug application (NDA) 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.

 

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

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Past Meetings

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