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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 11/13/13-11/14/13

Meeting Details:

On November 13, 2013, the committee will discuss supplemental biologics license application (sBLA) 103948-5139, alemtuzumab injection, proposed trade name LEMTRADA, submitted by Genzyme Corporation, a Sanofi Company. The proposed indication is for the treatment of patients with relapsing forms of multiple sclerosis to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations. On November 14, 2013, the committee will discuss new drug application (NDA) 205677, tasimelteon capsules, proposed trade name HETLIOZ, submitted by Vanda Pharmaceuticals, Inc. The proposed indication is for the treatment of Non-24 hour sleep-wake disorder in blind individuals without light perception.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 5/22/13-5/22/13

Meeting Details:

On May 22, 2013, the committee will discuss new drug application (NDA) 204569, for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 5/24/12-5/24/12

Meeting Details:

On May 24, 2012, the committee will discuss new drug application (NDA) 202737 for tafamidis meglumine capsules, proposed trade name VYNDAQEL, submitted by FoldRx Pharmaceuticals, Inc. a subsidiary of Pfizer, Inc. The proposed indication is for the treatment of transthyretin (TTR) familial amyloid polyneuropathy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 10/17/11-10/17/11

Meeting Details:

On October 17, 2011, the committee will discuss supplemental new drug application (sNDA) 21641 (013) for AZILECT (rasagiline mesylate) Tablets, manufactured by Teva Neuroscience, Inc., for the following proposed indication: Treatment of patients with idiopathic (of unknown cause) Parkinson's disease to slow clinical progression and treat the signs and symptoms of Parkinson's disease as initial monotherapy (the single drug used to treat) and as adjunct (additional) therapy to levodopa.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 3/10/11-3/10/11

Meeting Details:

On March 10, 2011, the committee will discuss, in general, the use of historical-controlled trials for the approval of anticonvulsant monotherapy for seizures of partial origin for antiepileptic drug products that are already approved for adjunctive therapy. The committee will also discuss how this may specifically apply to the approval of the supplemental new drug application 022115/S-011, LAMICTAL XR (lamotrigine extended-release tablets), sponsored by SmithKline Beecham Corp. d/b/a GlaxoSmithKline, for monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/20/11-1/21/11

Meeting Details:

On January 20, 2011, the committee will discuss new drug application (NDA) 202-008, florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of â-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer's disease. On January 21, 2011, the committee will discuss NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized cells that restrict passage of certain molecules from the bloodstream into the brain.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 11/3/10-11/3/10

Meeting Details:

On November 3, 2010, the committees will discuss a number of safety concerns with intravenous administration of the anti-seizure drugs phenytoin and fosphenytoin, including the condition known as Purple Glove Syndrome, and recommend what regulatory actions, if any, are necessary to diminish the risks.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 8/11/10-8/11/10

Meeting Details:

On August 11, 2010, the committee will discuss new drug application (NDA) 22-345, with the proposed trade name POTIGA (ezogabine) Tablets, by Valeant Pharmaceuticals North America. The proposed indication for this new drug product is adjunctive therapy in patients with partial-onset seizures.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

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

Meeting Details:

The committee will discuss new drug application (NDA) 22-527, with the proposed trade name GILENIA (fingolimod hydrochloride) 0.5 milligram (mg) capsules, by Novartis Pharmaceuticals Corporation. The proposed indication for this new drug product is treatment of relapsing forms of multiple sclerosis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 5/6/10-5/6/10

Meeting Details:

On May 6, 2010, the committee will discuss supplemental new drug application (sNDA) 22432, H.P. ACTHAR Gel (repository corticotropin injection), 80 USP units per milliliter, Questcor Pharmaceuticals, proposed for the treatment of infantile spasms.

 

       
Location: Marriott Conference Centers 3501 University Blvd. East Adelphi, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 10/14/09-10/14/09

Meeting Details:

The committee will discuss new drug application (NDA) 22250, with the proposed trade name AMAYA (fampridine) 10 milligram (mg) tablets, manufactured by Acorda Therapeutics, Inc. The proposed indication for this new drug product is to improve walking ability in individuals with multiple sclerosis (MS). MS is a neurological disease that may cause a wide variety of possible symptoms, including in some patients difficulty in walking.

 

       
Location: Peripheral and Central Nervous System Drugs Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 8/11/09-8/11/09

Meeting Details:

The committee will discuss a new drug application (NDA) for a radiopharmaceutical proposed for a special type of brain imaging in patients with movement disorders. NDA 22-454, Ioflupane I 123 Injection (proposed trade name DaTSCAN), GE HealthCare, is proposed for detecting loss of functional nigrostriatal dopaminergic neurons by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs of dopaminergic neurodegeneration.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/7/09-1/8/09

Meeting Details:

On January 7, 2009, the committee will discuss new drug application (NDA) 20-427, vigabatrin, Ovation Pharmaceuticals, Inc., for the proposed indication of adjunctive therapy for the treatment of refractory complex partial seizures in adults. January 8, 2009, the committee will discuss NDA 22-006, vigabatrin, Ovation Pharmaceuticals, Inc., for the proposed indication of treatment of infantile spasms.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System AdComm

Meeting Date: 10/23/08-10/23/08

Meeting Details:

The Committee will discuss the clinical development of radionuclide imaging products for the detection of amyloid to assist in the diagnosis of Alzheimer's Disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPCNS ADCOMM

Meeting Date: 8/6/08-8/7/08

Meeting Details:

On August 6, 2008, the committee will discuss new drug application (NDA) 20-42 7, vigabatrin, Ovation Pharmaceuticals, Inc., for the proposed indication of adjunctive therapy for the treatment of refractory complex partial seizures in adults. On August 7, 2008, the committee will discuss NDA 22-006, vigabatrin, Ovation Pharmaceuticals, Inc., for the proposed indication of treatment of infantile spasms.

 

       
Location: Hilton Washington DC Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint PCNS and Psychopharmacologic Drugs AdComm

Meeting Date: 7/10/08-7/10/08

Meeting Details:

The Peripheral and Central Nervous System Drugs Advisory Committee, the Psychopharmacologic Drugs Advisory Committee, representatives from the Pediatric Advisory Committee, and the Drug Safety and Risk Management Advisory Committee will consider the results of FDA's analysis of suicidality both suicidal ideation and behavior) from placebocontrolled clinical studies of 11drugs. The following drugs will be considered: (1)Carbamazepine (marketed as CARBATROL, Shire Pharmaceuticals, EQUETRO, Validus Pharmaceuticals, Inc., TEGRETOL, Tegretol XR, Novartis Pharmaceuticals Corp.); (2) felbamate (marketed as FELBATOL, Meda Pharmaceuticals, Inc.); (3) gabapentin (marketed as NEURONTIN, Pfizer, Inc.); (4) lamotrigine (marketed as LAMICTAL, GlaxoSmithKline); (5)levetiracetam (marketed as KEPPRA, UCB, Inc.); (6) oxcarbazepine (marketed as TRILEPTAL, Novartis Pharmaceuticals Corp.); (7) pregabalin (marketed as LYRICA, Pfizer Inc.); (8)tiagabine (marketed as GABITRIL, Cephalon, Inc.); (9)topiramate (marketed as TOPAMAX, Ortho-McNeil- Janssen Pharmaceuticals, Inc. ,); (10) valproate (marketed as DEPAKOTE, DEPAKOTE ER, DEPAKENE, DEPACON, Abbott Laboratories); and (11)zonisamide (marketed as ZONEGRAN, Dainippon). FDA will discuss with the committee actions taken in light of the results and whether any additional actions are necessary.

 

       
Location: Sheraton College Park Hotel Beltsville, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs

Meeting Date: 12/6/07-12/6/07

Meeting Details:

The committee will discuss new drug application (NDA) 21-894, tetrabenazine, Prestwick Pharmaceuticals, Inc., for the proposed indication to treat chorea associated with Huntington's disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 5/17/06-5/17/06

Meeting Details:

The committee will discuss supplemental new drug application (NDA) 20823, SE1-016, EXELON (rivastigmine tartrate) Capsules (1.5 milligrams (mg), 3.0 mg, 4.5 mg, and 6.0 mg), Novartis Pharmaceuticals Corporation, for the proposed indication of the treatment of mild to moderate dementia associated with Parkinson's disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPCNS Drugs AdComm

Meeting Date: 3/7/06-3/8/06

Meeting Details:

The committee will discuss TYSABRI (natalizumab) biologic license application 125104/15; Biogen Idec Inc., for an indication in patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. The committee will discuss the risks (including progressive multifocal leukoencephalopathy) associated with TYSABRI (natalizumab) administration, its efficacy in the treatment of multiple sclerosis relapses and/or disability, its possible return to the marketplace, and its proposed risk management plan(s).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPCNS AdComm

Meeting Date: 8/4/05-8/4/05

Meeting Details:

The committee will discuss new drug application (NDA) 21-645, proposed trade name MT100 (naproxen sodium and metoclopramide hydrochloride) Tablets, Pozen, Inc., for the proposed indication of acute treatment of migraine headache with or without aura.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 9/24/03-9/25/03

Meeting Details:

On September 24, the committee will discuss NDA 21-487 Memantine by Forest Labrotory Incorporated. Memantine is Indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. On September 25, the committee will NDA 20-717 Provigil Tablets by Cephalon Inc. Provigil is indicated for use to improve wakefulenss in patients with excessive sleepiness associated with dissorders of sleep and wakefulness.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPCNS Drugs Advisory Committee

Meeting Date: 5/16/03-5/16/03

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 20-690, supplement SE1-020, Aricept (donepezil hydrochloride tablets), Eisai Medical Research Inc., indicated for the treatment of vascular dementia.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Ad Comm

Meeting Date: 11/18/02-11/19/02

Meeting Details:

On November 18th, the committee will discuss the role of Brain imaging as an outcome measure on in Phase III trials of theratuic drugs of Alzheimer’s Disease. (Day 2 Cancelled) On November 19th, the committee will consider a supplemental new drug application for F18 FDG PET Imaging proposed to diagnose and or identify progression of Alzheimer’s Disease and other forms of dimensia.

 

       
Location: GHOL Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral & Central Nervous System Drugs

Meeting Date: 6/6/01-6/6/01

Meeting Details:

On June 6, 2001, the committee will consider the safety and efficacy of new drug application ( NDA) 21-196, Xyrem®, (sodium oxybate, Orphan Medical, Inc.) proposed to reduce the incidence of cataplexy and to improve the symptom of daytime sleepiness for persons with narcolepsy. A main focus of the deliberations will be on risk management issues.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and CNS Drugs Advisory Committee

Meeting Date: 3/13/01-3/15/01

Meeting Details:

On March 13, the committee will discuss drug development for individuals with mild cognitive impairment. On March 14, the committee will discuss drug development for individuals with vascular dementia. On March 15, the committee will consider the safety and efficacy of new drug application, Xyrem, proposed to reduce the incidence of cataplexy and to improve the symptom of daytime sleepiness for persons with narcolepsy.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs

Meeting Date: 1/27/00-1/28/00

Meeting Details:

On January 28, 2000, the committee will consider the safety and efficacy of NDA 21-120, Novantrone(mitoxantrone, Immunex Corp.) proposed to treat secondary progressive multiple sclerosis, including progressive relapsing disease. *** Day 1 Cancelled *** On January 27, 2000, the committee will consider the safety and efficacy of new drug application (NDA) 20-914, Promem TM (metrifonate, Bayer Corp., Pharmaceutical Division), proposed to treat mild to moderate dementia of the Alzheimer's type.

 

       
Location: Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs

Meeting Date: 4/28/99-4/29/99

Meeting Details:

On April 28, 1999, the committee will discuss the safety and efficacy of new drug application (NDA)20-884, Aggrenox™, (dipyridamole/aspirin capsules, Boehringer Ingelheim Pharmaceuticals, Inc.) proposed to reduce the combind risk of death and nonfatal stroke in patients who have had transient ischemia of the brain or completed ischemic stroke. On April 29, 1999, the committee will discuss the safety and efficacy of NDA 20-399, Freedox®, (tirilazad mesylate injection, Pharmacia and Upjohn, Inc.) proposed for the treatment of aneurysmal subarachnoid hemorrhage (SAH) to improve survival and functional outcome in patients with poor neurologic function following the initial hemorrhage.

 

       
Location: Holiday Inn Gaithersburg The Ballrooms 2 Montgom Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 5/8/97-5/8/97

Meeting Details:

The committee will discuss the safety and effectiveness of new drug application (NDA) 20-654 Myotrophin (human mecasermin (recombinant deoxyribonucleic acid (DNA) origin) Injection, Cephalon-Chiron Partners) for the treatment of amyotrophic lateral sclerosis (ALS).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral & CNS Drugs Advisory Committee

Meeting Date: 11/15/96-11/15/96

Meeting Details:

The committee will discuss the safety and effectiveness of NDA 20-648, Diastat (diazepam emulsion, Athena Neurosciences, Inc.), as a treatment for acute repetitive seizures.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 9/19/96-9/19/96

Meeting Details:

The committee will discuss the safety and effectiveness of COPAXONE (copolymer-1), NDA 20-622, TEVA Pharmaceuticals USA, as a treatment for patients with exacerbating- remitting multiple sclerosis.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 6/6/96-6/7/96

Meeting Details:

The committee will discuss product license application 96-0350 for Activase TM (alteplase), Genentech, for the management of acute ischemic stroke.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 12/4/95-12/4/95

Meeting Details:

The committee will discuss product license application 95-0979 from Biogen, Inc., for Interferon Beta-1a (Avonex TM), for treatment of relapsing forms of multiple sclerosis.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral & CNS Drugs

Meeting Date: 9/18/95-9/18/95

Meeting Details:

The committee will discuss the safety and effectiveness of Rilutek (riluzole), new drug application (NDA) 20-599, Rhone-Poulenc Rorer Pharmaceuticals, Inc., for use in the treatment of Amyotrophic Lateral Sclerosis (ALS).

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPeripheral & CNS Drugs

Meeting Date: 9/26/94-9/27/94

Meeting Details:

On September 26, 1994, the committee will discuss the safety and effectiveness of Freedox (tirilazad mesylate), new drug application (NDA) 20-399, The Upjohn Co., for use in the treatment of subarachnoid hemorrhage. On September 27, 1994, the committee will discuss the safety and effectiveness of Tegretol (carbamazepine), NDA 18-927, Basel Pharmaceuticals, for use as an anticonvulsant in children under 6 years old. Additionally, the committee will reconsider the relative risks and benefits of Felbatol (felbamate), NDA 20-189, Carter-Wallace, for use in the treatment of epilepsy.

 

       
Location: September 26 and 27, 1994, 8:30 a.m., conference rms. D and E, Parklawn Bldg., FDA 5600 Fishers Lane, Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

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

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Meeting Details:

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

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 7:30AM-5:15AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

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

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Meeting Details:

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

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel

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

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Meeting Details:

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

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies and ODAC

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

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Meeting Details:

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

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEar, Nose, and Throat Devices Panel

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

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Meeting Details:

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

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs Adcomm

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

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Meeting Details:

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

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 3/24/15-3/24/15

Meeting Details:

On March 24, 2015, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). The PAC will meet to discuss the following products: CYMBALTA (duloxetine hydrochloride), QUILLIVANT XR (methylphenidate hydrochloride), LUNESTA (eszopiclone), RISPERDAL (risperidone), OXTELLAR XR (oxcarbazepine), REVATIO (sildenafil), ADVAIR HFA (fluticasone propionate/salmeterol), DYMISTA (azelastine hydrochloride/fluticasone proprionate), QNASL (beclomethasone dipropionate), VENOFER (iron sucrose), INVIRASE (saquinavir), ALTABAX Ointment (retapamulin), FluMist QUADRIVALENT (influenza vaccine live, intranasal), FLUARIX QUADRIVALENT (influenza virus vaccine), Medtronic ACTIVA DYSTONIA THERAPY, and LIPOSORBER LA-15 System. In addition, there will be a short presentation of the ethical issues discussed by the Pediatric Ethics Subcommittee of the PAC on March 23, 2015.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee of the Pediatric AdComm

Meeting Date: 3/23/15-3/23/15

Meeting Details:

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart D. A brief summary of the subcommittee's discussion will then be presented to the FDA Pediatric Advisory Committee on Tuesday, March 24, 2015.

 

       
Location: Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 3/19/15-3/19/15

Meeting Details:

The committees will discuss supplemental new drug application 204275-S001, for fluticasone furoate and vilanterol inhalation powder (tradename Breo Ellipta) submitted by GlaxoSmithKline for the once daily maintenance treatment of asthma in patients 12 years of age and older. The discussion will include efficacy data, but the focus of the meeting will be safety, including the adequacy of the safety database to support approval, and whether a large safety trial to evaluate serious asthma outcomes is recommended.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled: Anesthetic and Analgesic Drug AdComm

Meeting Date: 3/18/15-3/18/15

Meeting Details:

The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indication of reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPostPoned: Arthritis AdComm

Meeting Date: 3/17/15-3/17/15

Meeting Details:

The committee will discuss biologics license application (BLA) 125544 for CTP13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) 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;(2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 3/9/15-3/9/15

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults. During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 3/4/15-3/4/15

Meeting Details:

On March 4, 2015, from 8:30 a.m. to 3 p.m., the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season.

 

       
Location: Hilton - Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-3:00PM    
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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