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Past Meetings

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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/17/14-6/17/14

Meeting Details:

On June 17, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the Maestro® Rechargeable System sponsored by Enteromedics, Inc. The Maestro® Rechargeable System provides VBLOC Therapy. The implantable device is a neuromodulator, which delivers high frequency (5000 Hertz), controllable electrical pulses to the intra-abdominal vagus nerve trunks. The effect of VBLOC therapy is reported to suppress neural signals carried by the vagus nerve trunks, resulting in decreased hunger pangs, decreased digestive enzyme secretion and calorie absorption, and increased satiety. The device consists of implantable electronic device components that deliver VBLOC therapy, and external components that regulate device performance. The proposed indication for use for the Maestro® Rechargeable System, as stated in the PMA, is as follows: The Maestro® Rechargeable System is indicated for use in weight reduction in adult patients with obesity that have a Body Mass Index (BMI) of at least 40 kilograms per square meter (kg/m2), or a BMI of at least 35 kg/m2 with one or more obesity related comorbid conditions, and have failed a more conservative weight reduction alternative.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 3/20/14-3/20/14

Meeting Details:

On March 20, 2014, the committee will discuss, make recommendations, and vote on information regarding the humanitarian device exemption (HDE) application for the XVIVO Perfusion System (XPSTM) sponsored by XVIVO Perfusion, Inc. The proposed Indication for Use for the XVIVO Perfusion System, as stated in the HDE, is as follows: The XPSTM is intended to be used with STEEN Solution for flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation.

 

       
Location: Holiday Inn, GBurg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/27/13-6/27/13

Meeting Details:

On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances. It consists of an extracorporeal blood system and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated carbon or resins, which may be coated or immobilized to prevent fine particles from entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. Sorbent hemoperfusion systems may also include the machine or instrument used to drive and manage blood and fluid flow within the extracorporeal circuit, as well as any accompanying controllers, monitors, or sensors. On April 4, 2013 (78 FR 20268), FDA issued a proposed order which, if made final, would reclassify sorbent hemoperfusion systems labeled for the treatment of poisoning and drug overdose class II subject to premarket notification [510(k)] and special controls, while sorbent hemoperfusion systems labeled for the treatment of hepatic coma and metabolic disturbances would remain class III requiring premarket approval (PMA) applications. The committee’s discussion will involve making recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of sorbent hemoperfusion devices labeled for the 3 treatment of poisoning and drug overdose. The regulatory history of sorbent hemoperfusion has been discussed as part of a previously published proposed rule (77 FR 9610). During session II on June 27, 2013, the committee will discuss and make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. The class III implanted blood access devices for hemodialysis include various flexible or rigid tubes, such as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic catheters that have a subcutaneous “cuff”' for tissue ingrowth. They are placed in a central vein to allow blood access. Chronic hemodialysis catheters serve as conduits for the removal of blood from the patient, delivery to a hemodialysis machine for filtering, and return of filtered blood to the patient. They have no moving parts, consisting, essentially, of flexible tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous catheters are totally implanted below the skin surface with no external communication. Arteriovenous shunts and vessel tips are tubing with tapered tips that are inserted into the artery and vein. The tubing is attached to the roughened or etched outer surface of the tip. The tubing is external to the skin and can be accessed with needles. They are similar to subcutaneous catheters. On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which, if made final, would make the class III implanted blood access devices class II subject to premarket notification [510(k)] and special controls. The regulatory history of implanted blood access devices has been discussed as part of the proposed rule (77 FR 36951). The committee’s discussion will involve making recommendations regarding regulatory classification to either reaffirm class III or reclassify these devices into class II and comment on 4 whether special controls are adequate to reasonably ensure the safety and effectiveness of this device.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 5/10/12-5/11/12

Meeting Details:

On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopically (balloons and suture devices) or laparoscopically (bands, space-occupying devices, etc.) and contrast those to surgery. Additional discussion will include issues pertaining to clinically meaningful weight loss, when the primary endpoint should be measured, length of patient followup, and how much risk is acceptable for a potentially small amount of weight loss.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

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

Meeting Details:

On January 11, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease.

 

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

Meeting Date: 12/2/10-12/3/10

Meeting Details:

On December 2, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal incontinence in patients who have failed conservative therapy. On December 3, 2010, the committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND Adjustable Gastric Banding System, sponsored by Allergan. The sponsor is requesting an expanded Indication for Use for their LAP-BAND Adjustable Gastric Banding System to include weight reduction in patients with a Body Mass Index (BMI) of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more comorbid conditions.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 12/11/09-12/11/09

Meeting Details:

On December 11, 2009, the committee will discuss and make recommendations on the study designs and endpoints of clinical investigations intended to support approval or clearance of devices indicated for the primary treatment of localized prostate cancer.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/10/09-6/10/09

Meeting Details:

The committee will discuss and make recommendations regarding general issues related to the use of ultrafiltration devices in the treatment of extracellular body fluid overload in patients experiencing heart failure. Specifically, the committee will address the use of these devices in patients experiencing heart failure in the following terms: Identifying the most appropriate heart failure patients for whom these treatments should be indicated, determining where these treatments fit within the spectrum of treatment options, and defining what level of clinical evidence is necessary to adequately evaluate and provide labeling for these devices.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/25/08-6/25/08

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Medical Enterprises, Ltd., for a drug/device combination product designed to prevent recurrence of bladder cancer. Synergo SB-3TS 101.1 Device with Mitomycin C is indicated for use for prophylactic treatment of recurrence in patients following endoscopic removal of Ta-TI and GI-3 superficial transitional cell carcinama of the bladder (STCCB). Ta-T1 refers to the stage of the tumor, which is a measure of how deep the tumor penetrates into the bladder wall, with Ta and T1 being the most superficial stages for raised bladder tumors. (21-3 refers to the tumor grade, which is a measure of how aggressive the tumor is likely fo grow, with G1 being the least aggressive, and G3 the most. Synergo and Mitomycin C treatment is clinically indicated for STCCB patients of intermediate and high risk.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/8/05-6/8/05

Meeting Details:

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. The committee will also discuss and make recommendations regarding general issues related to the premarket requirements for the safe and effective use of hemodialysis equipment labeled for nocturnal hemodialysis therapies.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 1/17/03-1/17/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of gastroesophageal reflux disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 8/17/01-8/17/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of fecal incontinence.

 

       
Location: Corporate Blvd. Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 10/19/00-10/19/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of vesicoureteral reflux.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 6/19/00-6/19/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a device for the treatment of obesity.

 

       
Location: Gaithersburg Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 10:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 11/19/99-11/19/99

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application (PMA) for an optical device intended to assist in the evaluation of colonic polyps using laser-induced autofluorescence.

 

       
Location: Corporate Bldg. Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 7/29/99-7/29/99

Meeting Details:

The committee will discuss, make recommendations and vote on a premarket approval application (PMA) for a urethral bulking and coaptation device for the treatment of stress urinary incontinence due to intrinsic sphincter insufficiency. The committee will also discuss possible revisions to the Draft Guidance For Preparation of PMA Applications for Testicular Prostheses, March 1993. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Corporate Bldg. 9200 Corporate Blvd. Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 10/29/98-10/29/98

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval supplement for a new indication for an extracorporeal immunoadsorption device intended for the treatment of rheumatoid arthritis.

 

       
Location: Corporate Building Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 7/30/98-7/30/98

Meeting Details:

Agency's Proposed reclassification of external shock wave lithotripters for kidney and uretheral stones.

 

       
Location: Corporate Building Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal and Urology Devices

Meeting Date: 4/30/98-4/30/98

Meeting Details:

The panel will discuss, make recommendations and vote on a premarket approval application for Medstone International's STS Lithotriper P970042 intended to fragment biliray stones. Anthony N. Kalloo, M.D., Gastroenterologist willl present a synopsis of the clinical data. Joseph H. Steinbach, Ph.D., Engineer and Biomathematician will present statistical review of the clinical data. The panel will consider the saftey and effectiveness of this device and the issues for consideration raised by the FDA.

 

       
Location: FDA Corporate Building, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs

Meeting Date: 2/22/96-2/23/96

Meeting Details:

On February 22, 1996, the committee will discuss new drug application (NDA) 20-580, Cotazyme, and NDA 20- 581, Cotazyme S and Zymase (pancreatic lipase, Organon), indicated for exocrine pancreatic insufficiency. On February 23, 1996, the committee will discuss NDA 20-617, C-14 Urea Breath Test (Trimed Specialties Inc.), for diagnosis of Helicobacter pylori .

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

Meeting Date: 5/12/15-5/12/15

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Meeting Details:

The committee will discuss new drug application (NDA) 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

 

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

Meeting Date: 5/12/15-5/12/15

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Meeting Details:

The committee will meet in open session to discuss the development and licensure of Ebola vaccines.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 5/13/15-5/13/15

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Meeting Details:

On May 13, 2015, the Committee will meet in open session to discuss strategies for implementation of serological and nucleic acid testing for Babesia microtiin blood donors. In the afternoon, the committee will hear update presentations on the following topics: 1) FDA considerations for Hemoglobin S Testing in blood donors; and 2) FDA considerations for a revised blood donor deferral policy for men who have sex with men. Following the update presentations, the committee will hear presentations on the research programs of the Laboratory of Cellular Hematology, Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.

 

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

Meeting Date: 5/14/15-5/15/15

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Meeting Details:

On May 14 and 15, 2015, the committee will discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States. FDA is convening this committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information. The committee will make recommendations on: (1) The effectiveness of cleaning, high level disinfection, and sterilization methods; (2) the amount and type of premarket validation data and information needed to support labeling claims and technical instructions; (3) the appropriate use of other risk mitigations, such as surveillance cultures; (4) best practices and guidelines for reprocessing duodenoscopes and endoscopes at user facilities to minimize the transmission of infections; and (5) recommended approaches for ensuring patient safety during ERCP procedures, including a discussion of appropriate patient selection. Recommendations on these issues will assist FDA in minimizing patient exposure to infectious agents that may result from reprocessed duodenoscopes and endoscopes.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communications

Meeting Date: 6/8/15-6/9/15

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Meeting Details:

On June 8 and 9, 2015, the Committee will discuss approaches to communicating information about fetal effects in product labeling for methadone or buprenorphine maintenance therapy for opioid addiction, and about the maternal benefits and risks of treatment, to best enable patients and health care providers to make informed decisions about the use of these drugs during pregnancy.06

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsSanofi Aventis PRALUENT - Endocrinologic & Metabolic Drugs AdComm

Meeting Date: 6/9/15-6/9/15

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Meeting Details:

The committee will discuss the safety and efficacy of biologics license application 125559, proposed trade name PRALUENT (established name: Alirocumab) for injection, submitted by Sanofi Aventis, U.S., as an adjunct to diet, for long-term treatment of adult patients with primary hypercholesterolemia (non-familial and heterozygous familial) or mixed dyslipidemia including patients with type 2 diabetes mellitus, to reduce low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, tryglyceride, and lipoprotein A, and to increase high-density lipoprotein cholesterol and apolipoprotein A-1 either in combination with a statin or as monotherapy including in patients who cannot tolerate statins.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAmgen REPATHA - Endocrinologic & Metabolic Drugs AdComm

Meeting Date: 6/10/15-6/10/15

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Meeting Details:

The committee will discuss the safety and efficacy of biologics license application (BLA) 125522, proposed trade name REPATHA (established name: Evolocumab) for injection, submitted by Amgen Inc., as adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL-C), TC/HDL-C, ApoB/ApoA1, very low-density lipoprotein cholesterol, triglyceride, and lipoprotein A, and to increase HDL-C and ApoA1, in adults with hyperlipidemia or mixed dyslipidemia, either in combination with a statin or statin with other lipid-lowering therapies (e.g., ezetimibe), or alone, or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or alone or in combination with other lipidlowering therapies in patients for whom a statin is not considered clinically appropriate. In addition, the committee will discuss the safety and efficacy of evolocumab to reduce LDL-C, TC, ApoB, and non-HDL-C, in combination with other lipid-lowering therapies (e.g. statins, LDL apheresis) in patients at least 12 years of age with homozygous familial hypercholesterolemia.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

Meeting Date: 4/30/15-5/1/15

Meeting Details:

On April 30, 2015, the committee will discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Insert),” Product Code EWD, as unclassified under the 510(k) premarket notification authority. Circumaural Hearing Protectors are currently regulated under the heading, “Protector, Hearing (Circumaural),” Product Code EWE, as unclassified under the 510(k) premarket notification authority. Middle Ear Inflation Devices are currently regulated under the heading, “Device, Inflation, Middle Ear,” Product Code MJV, as unclassified under the 510k) premarket notification authority. Tactile Hearing Aid Devices are currently regulated under the heading, “Hearing Aid, Tactile,” Product Code LRA, as unclassified under the 510(k) premarket notification authority. Vestibular Analysis Apparatuses are currently regulated under the heading, “Apparatus, Vestibular Analysis,” Product Code LXV, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the risks, safety and effectiveness and the regulatory classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. On May 1, 2015 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. These issues are categorized into three broad areas for discussion: 1. Cochlear implant changes (e.g. sound processing features, patient characteristics) that may be suitable for this pre- to post-market shift in clinical data requirements. 2. Appropriate premarket clinical data requirements to support pre- to post-market shift (e.g. leveraging clinical data from adults and/or older children.) 3. Clinical study design considerations (e.g. study endpoints and test metrics, subject characteristics) for post market studies to confirm safety and effectiveness and inform future labeling.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies and ODAC

Meeting Date: 4/29/15-4/29/15

Meeting Details:

The committees will discuss talimogene laherparepvec, Amgen, Inc., biologics license application (BLA) 125518, an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

Meeting Date: 4/17/15-4/17/15

Meeting Details:

On April 17, 2015, the committee will discuss the current knowledge regarding the conduct of clinical studies and evaluation of clinical study data for flow diverter technology. FDA is convening this committee to seek expert opinion on scientific and clinical considerations relating to the study design and existing clinical studies, for flow diverter technology indicated for the neurovasculature.

 

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

Meeting Date: 4/15/15-4/15/15

Meeting Details:

The committee will discuss new drug application New Drug Application 204958, cangrelor injection, submitted by The Medicines Company, for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/14/15-4/14/15

Meeting Details:

During the morning session, the committee will discuss the results of the cardiovascular outcomes trial (CVOT), Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, for new drug application (NDA) 22350, Onglyza (saxagliptin) and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets manufactured/marketed by AstraZeneca AB. During the afternoon session, the committee will discuss the results of the CVOT, Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care, for NDA 22271, Nesina (alogliptin); NDA 022426, Oseni (alogliptin and pioglitazone); and NDA 203414, Kazano (alogliptin and metformin) tablets marketed by Takeda Pharmaceutical U.S.A., Inc. Saxagliptin and alogliptin are dipeptidyl peptidase-4 (DPP4) inhibitors, both indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Both CVOTs were submitted in accordance with the 2008 FDA Draft Guidance, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 7:30AM-5:15AM    
Materials:
   
       

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