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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/1/14-8/1/14

Meeting Details:

On August 1, 2014, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed indication for use for the TissuGlu Surgical Adhesive device, as stated in the PMA is as follows: TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 6/26/13-6/26/13

Meeting Details:

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and 3 • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/2/13-5/2/13

Meeting Details:

On May 2, 2013, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juv[eacute]derm Voluma XC sponsored by Allergan, Inc. Juv[eacute]derm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juv[eacute]derm Voluma XC is indicated for deep (dermal/subcutaneous and/or submuscular/ supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 6/21/12-6/21/12

Meeting Details:

On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel of the Medical Devices

Meeting Date: 12/1/11-12/1/11

Meeting Details:

On December 1, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Contura, Inc., for AQUAMID, a new material (polyacrylamide) for use as a dermal filler for aesthetic treatment of wrinkles in the face. The AQUAMID dermal filler is intended for use in mid-to-deep subdermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/30/11-8/31/11

Meeting Details:

On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 4/27/11-4/27/11

Meeting Details:

On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/18/10-11/18/10

Meeting Details:

On November 18, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for MelaFind, sponsored by MELA Sciences. MelaFind(R) is a non-invasive and objective multi-spectral computer vision system designed to aid physicians in the detection of early melanoma from among clinically atypical (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 millimeters, evolving, patient concern, regression, and ``ugly duckling'') cutaneous pigmented lesions that are non-ulcerated, not bleeding, and less than 2.2 centimeters in diameter, when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.

 

       
Location: Holiday Inn College Park College Park, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/10-3/25/10

Meeting Details:

On March 25, 2010, the committee will review and discuss recent information, including recent literature regarding the possible risks to the general public from intentional exposure to ultraviolet radiation (UV) from use of tanning lamps. There continues to be a growing body of literature showing association of skin cancer with use of tanning lamps and the committee will discuss this information and other information related to the association of UV and skin cancer (both melanoma and non-melanoma). The committee will be asked to recommend whether changes to current classification or current regulatory controls of UV emitting devices (lamps) used for tanning are needed.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/18/08-11/19/08

Meeting Details:

On November 18, 2008, the committee will receive an update on safety information collected on dermal fillers in the commercial setting, discuss current premarket and postmarket approved study designs, and make recommendations on general issues concerning the study of various dermal fillers. In addition, the committee will discuss the design of clinical trials for future premarket submissions seeking approval of dermal fillers for new intended uses. On November 19, 2008, the committee will discuss and make recommendations on general issues related to the clinical trials of cosmetic devices. Specifically, the committee will make recommendations on how to quantify the effects of devices with various types of energy sources, such as light-based products, light-based combination devices, ultrasound devices (including focused ultrasound devices), massagers combined with other energy modalities, cryogenic energy devices, radiofrequency ablation devices, and microwave systems, on dermatologic conditions.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/24/06-8/25/06

Meeting Details:

On August 24, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients and a second PMA for the same device intended for use as a filler material to restore soft tissue facial contours such as nasolabial folds. On August 25, 2006, the committee will discuss and make recommendations on the reclassification, to Class II, of a Class III medical device: cyanoacrylate tissue adhesive.

 

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

Meeting Date: 8/25/05-8/26/05

Meeting Details:

On August 25, 2005, the committee will hear a presentation on the FDA 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. On August 25 and 26, 2005, the committee will discuss and make recommendations on the classification of five preamendments medical devices: Bone wax, medical maggots, medicinal leeches, tissue expander, and wound dressing with a drug.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsInamed & Mentor - General & Plastic Surgery

Meeting Date: 4/11/05-4/13/05

Meeting Details:

On April 11, 2005, the committee will hear oral presentations from the public. On April 12 and 13, 2005, the committee will discuss, make recommendations, and vote on two premarket approval applications for Silicone Gel-Filled Breast Prostheses. Related Link From Inamed. Also Mentor will be presenting: Related Link From Yahoo

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/12/04-5/12/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an in situ polymerizable sealant material intended to be used to seal air leaks following pulmonary surgery.

 

       
Location: Holiday Inn, GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/04-3/25/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/21/03-11/21/03

Meeting Details:

The committee will discuss, make recommendations, and vote on two premarket approval applications (PMAs) for injectable devices intended to restore soft tissue facial contours such as nasolabial folds.

 

       
Location: HOL Gaithersburg , MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 10/14/03-10/15/03

Meeting Details:

On October 14 and 15, 2003, the committee will discuss, make recommendations, and vote on a premarket approval application for Silicone Gel-Filled Breast Prostheses.

 

       
Location: Marriott Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-10:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/24/03-7/24/03

Meeting Details:

The committee will discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. There will also be a discussion of a general issue: clinical trial issues for devices designed for percutaneous removal of breast tumors.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 2/28/03-2/28/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an injectable wrinkle treatment device. There will also be a discussion of two general issues: (1) clinical trial issues for devices designed for ablation of pulmonary tumors, and 2) clinical trial issues for devices designed for the treatment of emphysema.

 

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

Meeting Date: 7/8/02-7/9/02

Meeting Details:

On July 8, 2002, the committee will discuss and make recommendations on the classification of a preamendment device, the silicone elastomer for scar management. The committee will also discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. On July 9, 2002, the FDA and two manufacturers of approved saline inflatable breast implant devices will present postmarket information to the committee for their consideration.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/17/01-7/17/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an Interactive Wound and Burn Dressing.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 5/8/00-5/8/00

Meeting Details:

The committee will discuss, make recommendations, and vote on two premarket approval applications: 1) for an in situ polymerizable surgical mesh intended to be used to seal air leaks following thoracic cavity surgery; and 2) for an interactive wound and burn dressing intended to be used for the treatment of diabetic foot ulcers by FocalSeal.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 3/1/00-3/3/00

Meeting Details:

On March 1, 2000, there will be a brief FDA presentation on the Least Burdensome provisions of the FDA Modernization Act of 1997. Also on March 1, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for Saline Inflatable Breast Prostheses. On March 2, 2000, the committee will discuss, make recommendations and vote on two PMAs for Saline Inflatable Breast Prostheses. On March 3, 2000, the committee will discuss content, format, and consistency issues involving the labeling information provided to patients considering saline-filled breast prostheses.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 1/12/00-1/12/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an Absorbable Adhesion Barrier Device.

 

       
Location: Corporate Bldg. Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 8/2/99-8/2/99

Meeting Details:

The committee will discuss possible revisions to the 1995 draft guidance

 

       
Location: Corporate Bldg., conference room 020B, 9200 Corpor Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 6/16/99-6/16/99

Meeting Details:

On June 16, 1999, the committee will discuss, make recommendations and vote on premarket approval application for computer-guided surgical instruments for use in endoscopic surgery. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Gaithersburg Hilton, Salons C, D, and E, 620 Perry Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 11/17/98-11/17/98

Meeting Details:

The committee will discuss and make recommendations on a proposal for the classification of preamendment wound dressing medical devices based on: 1) a proposed rule published in the Federal Register of September 19, 1989 (54 FR 38600); 2) comments received in response to the proposed rule; and 3)comments from the General and Plastic Surgery Devices Panel Meeting of July 20, 1995. The committee will also discuss and make recommendations on the reclassification of preamendment class III topical oxygen devices for woundhealing on extremities based on information received from a call for safety and effectiveness information under section 515(I) published in the Federal Registers of August 14, 1995 and June 13, 1997 (60 FR 41986 and 62 FR 32355, respectively).

 

       
Location: FDA Corporate Blvd., Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Broadcasting Live NOW

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/30/14-10/30/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 11/6/14-11/6/14

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Meeting Details:

During the morning session, the committee will discuss New Drug Application (NDA) 205353, panobinostat capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. During the afternoon session, the committee will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications (uses) for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD) and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

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

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Meeting Details:

On November 14, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens submitted by applicant Alcon Laboratories, Inc. This intraocular lens combines the optical properties of a +3 diopter multifocal intraocular lens with the optical properties of a toric intraocular lens. The proposed indication for use is: The AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens (IOL) are intended for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

 

       
Location: Hilton/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 11/24/14-11/25/14

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Meeting Details:

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling.

 

       
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: 12/12/14-12/12/14

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Meeting Details:

On December 12, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

       
Location: Holiday Inn-College Park Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

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

Meeting Date: 10/16/14-10/16/14

Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

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

Meeting Date: 10/8/14-10/9/14

Meeting Details:

On October 8, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding the Boston Scientific Corporation’s WATCHMAN Left Atrial Appendage (LAA) Closure Technology. FDA is seeking committee review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the previous advisory committee meeting on the WATCHMAN device, which was held December 11, 2013. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is indicated to prevent thromboembolism (TE) from the left atrial appendage. It may be considered for use in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy to reduce the risk of stroke and systemic embolism based on CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes, and prior stroke or transient ischemic attack (TIA)) or CHA2DS2-VASc (congestive heart failure, hypertension, age >75 years, diabetes mellitus, stroke/TIA/TE, vascular disease, age 65-74, and sex category) scores. On October 9, the committee will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves (MMM Allograft HVs). A MMM Allograft HV is a human valve or valved conduit that has been aseptically recovered from qualified donors, dissected free from the human heart, and then subjected to a manufacturing process(es) that alters the original relevant characteristics of the tissue (21 CFR 1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then stored until needed by a recipient. An example of such a manufacturing process is one that intentionally removes the cells and cellular debris with the goal of reducing in vivo antigenicity. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated under Product Code OHA, ‘‘Heart Valve, More than Minimally Manipulated Allograft,’’ as unclassified devices and reviewed under the premarket notification, 510(k), authority (21 CFR part 807). FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/23/14-9/23/14

Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

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

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Live Meetings

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Meeting Date: 10/21/14-10/21/14

Broadcasting Live NOW

Meeting Description:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.


 

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

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