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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 4/25/16-4/25/16

Meeting Details:

The committee will discuss new drug application (NDA) 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Boulevard East, Hyattsville, MD 20783 Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPOSTPONED: Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/22/16-1/22/16

Meeting Details:

The postponement is due to inclement weather forecasted for the Washington, DC area. The committee will discuss new drug application 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

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

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the DDSRM AdComm and the Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 5/4/16-5/4/16

Broadcasting Live NOW

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the committees will discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will seek the committees’ comments as to whether this REMS with ETASU assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

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

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc., with the proposed indication of short-term (up to 14 days) management of acute pain. The product has been formulated with the intent to provide abuse-deterrent properties. Benzhydrocodone is a hydrocodone prodrug which, according to the applicant, is rapidly converted into hydrocodone by enzymes in the gastrointestinal tract. The active drugs in this fixed-dose combination are hydrocodone and acetaminophen. The applicant has submitted data to support abuse-deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, and whether the nasal route of abuse is relevant for combination products made up of hydrocodone and acetaminophen.

 

       
Location: tbd Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/24/16-5/25/16

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Meeting Details:

On May 24th - The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. On May 25th - The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/24/16-5/24/16

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Meeting Details:

On May 24, 2016, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical's AMPLATZER Patent Foramen Ovale (PFO) Occluder. The AMPLATZER PFO Occluder is a percutaneously delivered permanent cardiac implant for PFO closure. The device is indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/24/16-5/25/16

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Meeting Details:

On May 24th - The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. On May 25th - The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

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

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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; 5 (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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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

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

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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: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

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

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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: TBD Related News Links: Not Available
Time: 8:00AM-2:00PM    
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    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 4/25/16-4/25/16

Meeting Details:

The committee will discuss new drug application (NDA) 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Boulevard East, Hyattsville, MD 20783 Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel of the Medical Devices AdComm

Meeting Date: 4/20/16-4/20/16

Meeting Details:

The Committee will discuss, make recommendations, and vote on the premarket approval application for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc. The Cartiva Synthetic Cartilage Implant (SCI) is an organic polymer-based biomaterial to mimic biologic cartilage. The device is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee Meeting

Meeting Date: 4/15/16-4/15/16

Meeting Details:

The committee will discuss data submitted by Galderma Laboratories, L.P. to support supplemental new drug application (sNDA) 20-380, for over-the-counter (OTC) marketing of adapalene gel 0.1%. The proposed OTC use is for the treatment of acne and to clear up acne pimples and acne blemishes. The applicant proposes to label the product for 12 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of adapalene gel 0.1% by OTC consumers.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/12/16-4/12/16

Meeting Details:

On April 12, 2016, 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). See the list of the products in this document to be discussed. In addition, FDA will be providing information on a proposed public advisory committee meeting for September 15 and 16, 2016, on appropriate pediatric development plans for prescription opioid drugs. Prior to the safety reviews and the open public hearing (see later in this section for further information), FDA will present, from approximately 8:30 to 9:30 a.m., a framework of current plans for a 2-day joint meeting of the PAC, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees. Elsewhere in this issue of the Federal Register, FDA is publishing an announcement of this advisory committee meeting to be held on September 15 and 16, 2016, on the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Following the presentation on the proposed framework for the September meeting, there will be an hour of open public hearing from 9:30 a.m. to 10:30 a.m. to provide an opportunity for the public to provide input concerning the topics before the PAC, including the use of opioids for control of severe pain in the pediatric population. To assist with the planning of this advisory committee meeting, FDA is establishing a public docket [Docket No. FDA-2016-N-0584] to receive input on appropriate pediatric development plans for prescription opioid drugs. The docket will remain open following the September advisory committee meeting. Comments about the upcoming September advisory committee meeting should not be submitted to the docket number listed at the top of this Federal Register notice [Docket No. FDA-2016-N-0567]. Please also see the ADDRESSES section of this notice for further docket information. The pediatric-focused safety reviews for the Centers will then occur. The PAC will meet to discuss the following products (listed by FDA Center): Center for Biologics Evaluation and Research (CBER): [cir] FLULAVAL QUADRIVALENT (influenza virus vaccine) [cir] FLULAVAL TRIVALENT (influenza virus vaccine) [cir] FLUZONE QUADRIVALENT (influenza virus vaccine) Center for Drug Evaluation and Research (CDER): [cir] ACIPHEX SPRINKLES (rabeprazole sodium) [cir] SKYLA (levonorgestrel-releasing intrauterine system) [cir] MYCAMINE (micafungin sodium) [cir] NOXAFIL (posaconazole) [cir] PRECEDEX (dexmedetomidine hydrocholoride) [cir] SABRIL (vigabatrim) [cir] SEROQUEL (quetiapine fumarate) and SEROQUEL XR (quetiapine fumarate extended-release) [[Page 8509]] [cir] SKYLA (levonorgestrel-releasing intrauterine system) [cir] SYMBAX (fluoxetine hydrocholoride and olanzapine) [cir] VYVANSE CAPSULES (lisdexamfetamine dimesylate) [cir] XELODA (capecitabine) Center for Devices and Radiological Health (CDRH): [cir] IMPELLA RP SYSTEM (humanitarian use device (HUD)) [cir] LIPSORBER LA-15 SYSTEM (HUD) [cir] MEDTRONIC ACTIVA DYSTONIA THERAPY (HUD) In addition to the agenda items, the PAC will remain in public session over the lunch hour on April 12, 2016, to hear a presentation and provide feedback on an FDA proposal for a risk-based approach to the pediatric-focused safety reviews mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The working lunch currently is scheduled between approximately 12:30 p.m. and 1:15 p.m.

 

       
Location: DoubleTree Bethesda 8120 Wisconsin Avenue Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee Meeting

Meeting Date: 4/12/16-4/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 208542 rociletinib tablets, application submitted by Clovis Oncology, Inc. The proposed indication (use) for this product is for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

 

       
Location: TBD Related News Links: Not Available
Time: 8:30AM-1:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 4/7/16-4/7/16

Meeting Details:

The committee will discuss new drug application (NDA) 207999, obeticholic acid oral tablets, submitted by Intercept Pharmaceuticals, Inc., proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the DDSRM AdComm and the Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 5/4/16-5/4/16

Broadcasting Live NOW

Meeting Description:

The Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the committees will discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will seek the committees’ comments as to whether this REMS with ETASU assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.


 

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