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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

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

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    
Materials:
   
       

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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 OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 6/28/16-6/28/16

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 204629 for empagliflozin (JARDIANCE) tablets and sNDA 206111 for empagliflozin and metformin hydrochloride (SYNJARDY) tablets. Both sNDAs are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure.

 

       
Location: Hilton Washington DC/Rockville Rockville, MD 20852 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Oncologic Drugs Advisory Committee

Meeting Date: 6/28/16-6/28/16

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Meeting Details:

On June 28, 2016, information will be presented for expert assessments related to exploring potential pediatric development plans for four products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) venetoclax, presentation by AbbVie, Inc. (2) tazemetostat, presentation by Epizyme, Inc., and (3) atezolizumab, presentation by Roche/Genentech.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Oncologic Drugs Advisory Committee

Meeting Date: 6/29/16-6/29/16

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Meeting Details:

On June 29, 2016, during the morning session, information will be presented for expert assessments related to exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) LOXO-101, presentation by Loxo Oncology, Inc., and (2) entrectinib, presentation by Ignyta, Inc.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:30AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 7/12/16-7/12/16

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Meeting Details:

The committee will discuss biologics license application 761024, for ABP 501, a proposed biosimilar to AbbVie Inc.'s HUMIRA (adalimumab), submitted by Amgen, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs)); (2) reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older (alone or in combination with methotrexate); (3) reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (alone or in combination with non-biologic DMARDs); (4) reducing signs and symptoms in adult patients with active ankylosing spondylitis; (5) reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy (ABP 501 would be indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab); (6) inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP) (the effectiveness of ABP-501 would not be established in patients who have lost response to or were intolerant to TNF blockers); and (7) treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate (only to be administered to patients who will be closely monitored and have regular follow-up visits with a physician).

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 7/13/16-7/13/16

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Meeting Details:

The committee will discuss biologics license application 761042, for GP2015, a proposed biosimilar to Amgen Inc.’s ENBREL (etanercept) submitted by Sandoz, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate (MTX) or used alone); (2) reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older; (3) reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (in combination with MTX in patients who do not respond adequately to MTX alone); (4) reducing signs and symptoms in patients with active ankylosing spondylitis; and (5) treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 7/19/16-7/19/16

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Meeting Details:

The committee will discuss biologics license application (BLA) 761032, brodalumab injection, a human monoclonal antibody, submitted by Valeant Pharmaceuticals Luxembourg S.à.r.l, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices Panel of the MDAC

Meeting Date: 7/21/16-7/22/16

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Meeting Details:

On July 21, 2016, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application (PMA) panel-track supplement for a proposed change in intended use of Dexcom, Inc.’s, Dexcom G5® Mobile Continuous Glucose Monitoring System (CGM) device so that, in addition to tracking and trending interstitial fluid glucose concentrations, patients can use the device as a replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.
On July 22, 2016, the committee will discuss and make recommendations on information regarding a premarket notification (510(k)) submission for the Alere Afinion™ HbA1c Dx point-of-care test system, sponsored by Alere Technologies AS. The proposed intended use, as stated by the sponsor: Alere Afinion HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human whole blood. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. For use in clinical laboratories and point of care laboratory settings.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies Advisory Committee

Meeting Date: 7/26/16-7/26/16

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Meeting Details:

On July 26, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Molecular Oncology and the Laboratory of Biological Chemistry, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 1:00PM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting-Anesthetic and Analgesic Drug Products AC, the DSRM AC, and the Pediatric AC

Meeting Date: 9/15/16-9/16/16

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Meeting Details:

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding Advisory Committee

Meeting Date: 6/23/16-6/23/16

Meeting Details:

The committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The nominators of these substances will be invited to make a short presentation supporting the nomination. During the afternoon session, the committee will receive updates on certain issues to follow up on discussions from previous meetings, including the option for obtaining access to investigational new drugs under expanded access.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 6/20/16-6/20/16

Meeting Details:

On June 20, 2016, the Committee members will participate in the meeting via teleconference. In open session, the Committee will discuss the research programs in the Laboratory of Plasma Derivatives in the Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 9:30AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 6/9/16-6/9/16

Meeting Details:

The committee will discuss biologics license application (BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed indication of prevention of Clostridium difficile infection recurrence.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/8/16-6/8/16

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207621, oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, submitted by Pfizer, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abuse-deterrent properties based on the presence of naltrexone, an opioid antagonist, in the formulation. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 9:30AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/7/16-6/7/16

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207975, hydrocodone bitartrate extended-release tablets, submitted by Teva Branded Pharmaceutical Products R&D, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abusedeterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: TBD Related News Links: Not Available
Time: 9:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/2/16-6/3/16

Meeting Details:

On June 2 and 3, 2016, the committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. FDA is convening this committee to seek expert scientific and clinical opinion related to contamination of heater-cooler devices, associated patient infections, and mitigation strategies based on available scientific information. The committee will make recommendations on: (1) the effectiveness of cleaning and disinfection methods for heater-cooler devices; (2) the amount and type of premarket data and information needed to demonstrate validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; (3) appropriate risk mitigations to be implemented by manufacturers of heater-cooler devices and/or hospital facilities to ensure patient safety during surgical procedures where these devices are used; and (4) appropriate guidelines and/or criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries. Recommendations on these issues will assist FDA in minimizing patient exposure to infections that may result from contaminated heater-cooler devices.

 

       
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.

Live Meetings

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