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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

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

Meeting Details:

On June 6, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the KAMRA Inlay (Model ACI 7000) (KAMRA Inlay) submitted by applicant AcuFocus, Inc. The KAMRA Inlay is a permanent corneal implant that is placed intrastromally in a corneal pocket or under a corneal flap. The opaque annulus of the inlay reduces the aperture of the eye, which improves near vision by providing an increased depth of focus in the implanted eye. The proposed indication for use states that the KAMRA Inlay is indicated for the improvement of near and intermediate vision in presbyopic patients who require near or intermediate correction. The KAMRA Inlay is intended to be placed intrastromally in the cornea, on the visual axis, by way of a femtosecond laser-created pocket using a spot/line separation of 6x6 microns (µ) or less. The KAMRA Inlay should be placed at a depth equal to or greater than 180 µ.

 

       
Location: Hilton Washington, DC North/Gaithersburg Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/13/14-5/13/14

Meeting Details:

On May 13, 2014, the committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

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

Meeting Details:

On February 14, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Visian Toric Implantable Collamer Lens (TICL) sponsored by STAAR Surgical Company. "Visian TICL proposed indications for use: • For adults 21-45 years of age; • For correction of myopic astigmatism in adults with spherical equivalent ranging from -3.0D to =-15.0D with cylinder of l.0D to 4.0D; • For the reduction of myopic astigmatism in adults with spherical equivalent ranging from greater than -15.0D to -20.0D with cylinder l.0D to 4.0D; • With an anterior chamber depth (ACD) of 3.0 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 Diopter for 1 year prior to implantation); and • The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye."

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 9/19/13-9/19/13

Meeting Details:

On September 19, 2013, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the ReSure Sealant sponsored by Ocular Therapeutix, Inc. The ReSure Sealant is an in situ formed hydrogel that is applied topically to clear corneal incisions to create an adherent temporary, soft and lubricious sealant. The ReSure Sealant proposed indication for use is the intraoperative management of clear corneal incisions with a wound leak demonstrated by Seidel test, and for prevention of postoperative fluid egress following cataract or intraocular lens placement surgery.

 

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

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

Meeting Date: 4/8/13-4/8/13

Meeting Details:

On April 8, 2013, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Trulign Toric posterior chamber intraocular lens sponsored by Bausch and Lomb. The Trulign Toric posterior chamber intraocular lens is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision and reduction of residual refractive cylinder. Trulign Toric provides approximately one diopter of monocular accommodation, which allows for near, intermediate, and distance vision without spectacles.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:30AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 9/28/12-9/28/12

Meeting Details:

On September 28, 2012, the committee will discuss, make recommendations and vote on information regarding the humanitarian device exemption (HDE) application for the Argus II Retinal Prosthesis System sponsored by Second Sight Medical Products, Inc. The proposed Indication for Use for the Argus II (as stated in the HDE) is as follows: The Argus II System is indicated for use in patients with severe to profound retinitis pigmentosa who meet the following criteria: • Adults, age 25 years or older. • Bare light or no light perception in both eyes with Snellen acuity worse than 20/2100 or 2.1 logMAR. If the patient has no residual light perception, the retina must be able to respond to electrical stimulation as evidenced by an electrically evoked response. • Previous history of useful form vision.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel of the Medical Devices

Meeting Date: 7/30/10-7/30/10

Meeting Details:

On July 30, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS–100 L/R, sponsored by Glaukos Corp. The device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in subjects with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. For this device, the patients should have normal gonioscopic anatomy and a visually significant cataract eligible for phacoemulsification. The patient’s glaucoma should be considered mild to moderate Primary Open Angle Glaucoma, or the secondary open angle glaucomas, Pigmentary Glaucoma and Pseudoexfoliation Glaucoma. Patients with other causes of secondary open angle glaucoma or angle closure glaucomas are not eligible for use of this device. Patients’ IOP should be controlled on 1–3 glaucoma medications and patients should not previously have had surgery for glaucoma.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 3/27/09-3/27/09

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMTTM). The IMTTM is indicated for monocular implant in patients greater than 65 years of age with stable moderate to profound central vision impairment, i.e., distance BCVA of 20/80 to 20/800, due to bilateral central scotomas associated with end-stage macular degeneration, defined as retinal findings of geographic atrophy or disciform scar, with foveal involvement as determined by fluorescein angiography and evidence of cataract.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 6/10/08-6/10/08

Meeting Details:

The committee will discuss general issues concerning the postmarket experience with various contact lens care products. The discussion will include recommendations on contact lens care product development topics such as preclinical testing and clinical performance measures, and + labeling for contact lenses and lens care products.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 4/24/08-4/25/08

Meeting Details:

On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Visioncare Technologies, Inc., for an implantable miniature telescope (IMT). The IMT, a visual prosthetic device, is indicated for monocular implant in patients with stable, moderate to profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration with geographic atrophy or disciform scar, foveal involvement, and cataract. On April 25, 2008, the committee will discuss general issues concerning the post market experience with phakic intraocular lenses and laser-assisted in situ keratomileusis (LASIK).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 7/14/06-7/14/06

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics, Center for Devices and Radiological Health, outlining their responsibility for the review of postmarket study design. Subsequently, the committee will discuss, make recommendations, and vote on a premarket approval application for an implantable miniature telescope (IMT). The IMT™, is a visual prosthetic device which, when combined with the optics of the cornea, constitutes a telephoto lens and is indicated for use in patients with bilateral, stable macular degeneration and other bilateral, stable untreatable central vision disorders.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:45AM-6:00PM    
Materials:
   
       

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

Meeting Date: 3/5/04-3/5/04

Meeting Details:

The committee will discuss general issues surrounding the use of intraocular lenses for correction of presbyopia after clear lens extraction. The committee will address clinical study design elements including the risk/benefit ratio for patients with various refractive errors, study sample size, the need for control groups, inclusion/exclusion criteria, and the incidence of retinal detachment and other complications.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 9:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel of the Medical Devices AdComm

Meeting Date: 2/5/04-2/6/04

Meeting Details:

On February 5, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a phakic intraocular lens for the reduction or elimination of myopia in adults. On February 6, 2004, the committee will discuss, make recommendations and vote on a PMA for a radiofrequency electrosurgical corneal shaping device for the temporary treatment of presbyopia.

 

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

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

Meeting Date: 10/3/03-10/3/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an implantable contact lens for the correction of moderate to high myopia between -3.0 diopters (D) to -20 D with or without astigmatism up to 2.5D and is intended for placement in the posterior chamber of the phakic eye.

 

       
Location: Gaithersburg Marriott Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/23/03-5/23/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an intraocular lens for primary implantation in the capsular bag for the correction of aphakia in an adult in whom a cataractous lens has been removed and who may benefit from improved near, intermediate and distance vision without spectacles.

 

       
Location: Marriot - Rio Related News Links: Not Available
Time: 8:30AM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 8/1/02-8/2/02

Meeting Details:

On August 1, 2002, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an excimer laser system for use in wavefront guided laser in-situ keratomileusis (LASIK) correction for the reduction or elimination of myopia up to -7 diopters (D) with less than -0.50D of astigmatism at the spectacle plane in subjects who are 21 years of age or older. On August 2, 2002, the committee will discuss issues related to the development of an FDA guidance, an American National Standards Institute (ANSI) standard, and an International Standards Organization (ISO) standard for intraocular lenses (IOLs) for the treatment of myopia or hyperopia in phakic patients. The committee will address questions on clinical study design, specular microscopy (endothelial cell counts), lens opacity, and contrast sensitivity.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel Advisory Committee

Meeting Date: 1/17/02-1/18/02

Meeting Details:

**** Meeting Not Available for Webcasting on the 17th.**** On January 17, 2002, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) on an endocapsular tension ring for the stabilization of the lens capsular bag. On January 18, 2002, the committee will discuss, make recommendations, and vote on a PMA on an orthokeratology contact lens for corneal refractive therapy with overnight wear for the temporary reduction of myopia.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 11/30/01-11/30/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a conductive keratoplasty (CK) refractive surgical device for the reduction of previously untreated spherical hyperopia in patients 40 years of age or greater, who have 0.75 D to 3.25 D of cycloplegic spherical hyperopia, with less than or equal to 0.75 D of refractive astigmatism (minus cylinder format), a cycloplegic spherical equivalent of 0.75 D to 3.00 D, and no more than 0.50 D difference between pre-operative manifest refraction spherical equivalent (MRSE) and cycloplegic refraction spherical equivalent (CRSE) which shows some regression of the initial effect over time.

 

       
Location: Gaithersburg Holiday Inn Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 9/21/01-9/21/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for soft contact lenses for the correction of refractive ametropia (myopia or hyperopia) in phakic or aphakic persons with non-diseased eyes exhibiting astigmatism of 2.00 diopters (D) or less that does not interfere with visual acuity. The lenses may be prescribed for daily wear or extended wear for 1 to 30 days between removals for cleaning and disinfection or for disposal of the lens, as recommended by the eye care professional. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. The committee will also discuss, make recommendations and vote on a conductive keratoplasty (CK) refractive surgical device for the reduction of previously untreated spherical hyperopia in patients 40 years of age or greater, who have 0.75 D to 3.25 D of cycloplegic spherical hyperopia, with less than or equal to 0.75 D of refractive astigmatism (minus cylinder format), a cycloplegic spherical equivalent of 0.75 D to 3.00 D, and no more than 0.50 D difference between pre-operative manifest refraction spherical equivalent (MRSE) and cycloplegic refraction spherical equivalent (CRSE) which shows some regression of the initial effect over time.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 7/20/01-7/20/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for soft contact lenses for the optical correction of refractive ametropia in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism. The lenses may be prescribed for extended wear for up to 30 nights of continuous wear between removals for cleaning and disinfection or for disposal of the lens, as recommended by the eye care professional.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 11/8/00-11/8/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a collagen glaucoma drainage device for the reduction of intraocular pressure in patients with open-angle glaucoma uncontrolled on maximum tolerated medical therapy. The committee will also discuss issues related to the development of guidance for the post-approval study of extended wear contact lenses used beyond seven days. Study design topics will include the type of study, definition of endpoints, and selection of participating study sites.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/11/00-5/12/00

Meeting Details:

On May 11, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for reduction or elimination of hyperopia (+0.5 to +5.00 diopters of sphere) with astigmatism (+0.5 to +4.0 diopters of cylinder) using photorefractive keratectomy (PRK). On May 12, 2000, the committee will discuss issues related to the design and development of clinical protocols to support claims of reduced posterior capsular opacification (PCO) for intraocular lenses (IOLs). The topics for discussion will include study methodology, controls, clinical endpoints and data analysis. The committee will also discuss issues related to the development of guidance for refractive implants (phakic IOLs and corneal implants). The topics for discussion will include the scope of the proposed guidance, the maintenance of endothelial cell counts, and cataractogenesis due to the presence of an implant.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 9:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 3/17/00-3/17/00

Meeting Details:

FDA staff will make a brief presentation to the committee on the Least Burdensome provisions of the FDA Modernization Act of 1997. The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an excimer laser for the reduction or elimination of hyperopia up to +6.00 D of sphere and up to -6.00 D of astigmatism at the spectacle plane using laser in situ keratomileusis (LASIK).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 1/13/00-1/14/00

Meeting Details:

On January 13, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for a holmium laser for the correction of hyperopia using laser thermal keratomileusis (LTK). On January 14, 2000, the committee will discuss and make recommendations on (1) the reclassification of an artificial eye lubricating solution and (2) the classification status for currently unclassified eyelid weight devices.

 

       
Location: Corporate Bldg. Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 9/23/99-9/23/99

Meeting Details:

On September 23, 1999, from 8:30 a.m. to 1:30 p.m., the committee will hear formal presentations followed by public participation in a discussion of keratomes. Public participants in the group discussion are requested to develop a comprehensive list of problems associated with keratomes, the related causes, and the steps that can be taken to mitigate the problems. From 1:30 p.m. to 5 p.m., the committee will discuss issues related to defining the scope and purpose of a proposed keratome guidance to be developed from an outline of contents currently recommended for keratome premarket notification submissions. Single copies of the outline are available to the public by contacting the person noted above.

 

       
Location: Holiday Inn Silver Spring Lincoln Ballroom 8777 Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 7/22/99-7/23/99

Meeting Details:

On July 22, 1999, the committee will discuss, make recommendations, and vote on a premarket approval application(PMA) for the correction of myopia with and without astigmatism using laser in-situ keratomileusis (LASIK). The committee will also discuss, make recommendations, and vote on a holmium laser for the correction of hyperopia using laser thermal keratomileusis (LTK). On July 23, 1999, the committee will discuss, make recommendations, and vote on a soft acrylic intraocular lens for the visual correction of aphakia after cataract extraction. The committee will also discuss, make recommendations, and vote on a PMA for the correction of myopia with and without astigmatism using LASIK. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Gaithersburg Hilton Salons A and B 620 Perry Par Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 1/12/99-1/12/99

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for intrastromal corneal ring segments for the correction of myopia from -1.00 to -3.50 diopters in patients having 1.0 diopter or less of astigmatism.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 10/22/98-10/23/98

Meeting Details:

On October 22, 1998, the committee will discuss issues related to the development of extensions to the guidance document for refractive surgical lasers to include the clinical criteria for the determination of safety and effectiveness for photorefractive keratectomy (PRK) and laser in-situ keratomileusis (LASIK) for myopia and hyperopia with and without astigmatism, presbyopia, and other refractive indications. On October 23, 1998, the committee will discuss issues related to the preliminary development of guidance for refractive implants (phakic intraocular lenses and corneal implants) to include clinical protocol design and development.

 

       
Location: Holiday Inn Silver Spring, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 7/22/98-7/22/98

Meeting Details:

The committee will discuss new drug application (NDA) 20-961, Vitravene (fomivirsen sodium intravitreal injection, ISIS Pharmaceuticals), for treatment of cytomegalovirus(CMV)Retinitis in patients with acquired immune deficiency syndrome (AIDS).

 

       
Location: Holiday Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 6/5/98-6/5/98

Meeting Details:

The committee will discuss a premarket approval application (PMA) for an excimer laser to correct myopia using laser in-situ keratomileusis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic / Ophthalmic / Antiviral Drugs Advisory Committee

Meeting Date: 12/8/95-12/8/95

Meeting Details:

The committee will discuss data relevant to the new drug application (NDA) 20-569 ganciclovir intravitreal implant (Vitrasert Sterile Intravitreal Implant, Chiron Vision Corp.) for treatment of cytomegalovirus retinitis. The committee will also discuss data relevant to NDA 20-597 latanoprost (Xalatan TM Sterile Ophthalmic Solution, Pharmacia, Inc.) a topical ophthalmic drug indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

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Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm (Forrest Labs)

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

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Meeting Details:

The committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

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

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Meeting Details:

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Methodological Considerations in Evaluation of Cancer

Meeting Date: 9/10/14-9/11/14

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Meeting Details:

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

 

       
Location: The DoubleTree by Hilton Hotel Washington DC—Silver Spring The Pinnacle Grand Ballroom 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Endocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

Meeting Date: 9/11/14-9/11/14

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Endocrinologic and Metabolic Drugs AdComm (NPS Pharma)

Meeting Date: 9/12/14-9/12/14

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Meeting Details:

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Bone, Reproductive and Urologic Drugs AdComm

Meeting Date: 9/17/14-9/18/14

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Meeting Details:

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| FDA’s GDUFA Public Hearing on Policy Development

Meeting Date: 9/17/14-9/17/14

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Meeting Details:

FDA is hosting the Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation. FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics. We will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities.

 

       
Location: College Park Marriott Hotel and Conference Center 3501 University Boulevard East Hyattsville, MD 20783 Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Pediatric AdComm

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

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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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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting Options| Gastroenterology and Urology Devices Panel

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

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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 OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

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

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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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

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

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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    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

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

Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsConfidentiality of Interim Results in Cardiovascular Outcome Safety Trials

Meeting Date: 8/11/14-8/11/14

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic.

 

       
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: 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 OptionsBlood Products Advisory Comm

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

Meeting Details:

On the morning of July 31, 2014, the committee will meet in open session to discuss Baxter Healthcare Corporation’s biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. In the afternoon, the Committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results.

 

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

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

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