FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs AdComm

Meeting Date: 4/19/18-4/19/18

Meeting Details:

The committee will discuss new drug application (NDA) 210365, cannabidiol oral solution, sponsored by GW Pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPCNS AdComm

Meeting Date: 9/28/17-9/28/17

Meeting Details:

The committee will discuss new drug application (NDA) 200896, ataluren for oral suspension, sponsored by PTC Therapeutics, Inc., for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene.

 

       
Location: FDA Meeting Room (TD) Related News Links: Not Available
Time: 9:00AM-4:30PM    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/30/19-5/31/19

.

Meeting Details:

On May 30, 2019, the committee will discuss and make recommendations regarding the reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls). On May 31, 2019, the committee will discuss and make recommendations regarding the reclassification of certain absorbable hemostatic agents from Class III to Class II (special controls).

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

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

.

Meeting Details:

The committee will discuss new drug application (NDA) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment- intolerant or non-responsive multidrug-resistant tuberculosis (TB).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint DSRM and Anesthetic and Analgesic AdComm

Meeting Date: 6/11/19-6/12/19

.

Meeting Details:

FDA is seeking public input on the clinical utility and safety concerns associated with the higher range of opioid analgesic dosing (both in terms of higher strength products and higher daily doses) in the outpatient setting. FDA is interested in better understanding current clinical use and situations that may warrant use of higher doses of opioid analgesics. We are also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients. FDA frequently hears from patients and healthcare providers that higher dose opioid analgesics continue to be a unique and necessary part of effective pain management for some patients. FDA is also cognizant of serious safety concerns associated with both higher strengths and higher daily doses of opioid analgesics, both in patients and in others who may access these drugs. Higher strength products may be more harmful in cases of accidental exposure and overdose and may also be more sought out for misuse and abuse. Along with a number of other factors, a higher daily opioid dose is associated with greater risk of overdose. Concerns have also been raised that higher dose opioid regimens may carry a higher risk of addiction, although robust evidence for a causal relationship is lacking. There is a strong association between higher opioid dose and duration/persistence of opioid analgesic therapy and assessing temporal relationships and independent effects of opioid dose and duration on the risks of both addiction and overdose is challenging. In addition, FDA acknowledges the complex and evolving landscape of the opioid epidemic, with myriad Federal, State, local, and payer efforts to encourage more judicious prescribing of opioid analgesics, and the growing threat of highly lethal illicit opioids. To better understand both the clinical utility and harms of higher dose opioid analgesics in the current environment, and to discuss the advantages and disadvantages of various potential risk management strategies, FDA brings these issues to an advisory committee to seek input and advice from the clinical, patient, public health, and research communities. In particular, FDA seeks to discuss: (1) The current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/19/19-6/20/19

.

Meeting Details:

On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices. FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of ODAC

Meeting Date: 6/20/19-6/20/19

.

Meeting Details:

During the morning session, the particular matter for this meeting will be review and discussion of the FDA Reauthorization Act of 2017 (FDARA) mandated Relevant Pediatric Molecular Target List now posted on the FDA website: https://www.fda.gov/?AboutFDA/?CentersOffices/?OfficeofMedicalProductsandTobacco/?OCE/?ucm544641.htm. FDA is required by statute to review and update the previously approved and published lists. The focus of the discussion will be limited to two target “classes” included in the Relevant Pediatric Molecular Target List: (1) Targets linked to cell lineage and (2) targets on normal immune cells and cells in the tumor microenvironment. Planned introductory presentations will be on: (1) Cell-based therapy approaches to childhood cancer and (2) novel membrane antigen determinants in pediatric tumors. During the afternoon session, information will be presented to gauge investigator interest in 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) ONC201, presentation by Oncoceutics Inc., and (2) CD24Fc, presentation by OncoImmune, Inc.

 

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

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 5/14/19-5/14/19

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 211810 for pexidartinib capsule, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adult patients with symptomatic tenosynovial giant cell tumor, also referred to as giant cell tumor of the tendon sheath or pigmented villonodular synovitis, which is associated with severe orbidity or functional limitations, and which is not amenable to improvement with surgery. During the afternoon session, the committee will discuss NDA 212166 for quizartinib tablets, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory acute myeloid leukemia, which is FLT3-ITD positive, as detected by an FDA-approved test.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 5/8/19-5/8/19

Meeting Details:

The committee will discuss new drug application (NDA) 202049, for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 5/7/19-5/7/19

Meeting Details:

The committee will discuss the following topics: (1) Approaches to evaluate the effect of renal impairment on drug exposure, and (2) best practice considerations for translating pharmacokinetic (PK) information into dose individualization instructions. Regarding topic 1, many registration trials exclude patients with advanced kidney disease, and product labeling dosing instructions for these patients are commonly derived from our understanding of the change in the PK in individuals with varying degrees of renal function. The most common current approach to determine dosing instructions for patients with varying degrees of renal function begins with a stand-alone renal impairment study, either full design or reduced design. In addition to stand-alone renal impairment studies, drug development programs often use the findings from population PK (POPPK) analyses, which leverage the PK information across all the studies available in a drug development program. An alternative approach to consider is for drug development programs to predict the impact of renal impairment on the PK of the drug, either based on the understanding of the PK of a new molecular entity or using physiologic based PK (PBPK) models, without a stand-alone renal impairment study. Patients with impaired renal function can then be included in later stage clinical trials, with prospective dose adjustment incorporated if deemed necessary based the predictions. The dosing should be confirmed based on analysis of PK samples from the late stage trials (sparse PK, POPPK analysis). Regarding topic 2, dose individualization is typically achieved by applying the concept of `exposure-matching' under the assumption that such a maneuver will result in a benefit-risk similar to that observed in the registration trials. The committee will discuss the application of `exposure matching,' including the necessary assumptions and any limitations.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm

Meeting Date: 4/25/19-4/26/19

Meeting Details:

Day 1 - On April 25th, The committee will discuss one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis. Day 2 - On April 26th, The committee will discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only approved indication for bacitracin for intramuscular injection. The committee will also consider whether there are other uses for bacitracin for intramuscular injection that could be studied. FDA will present background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Past Meetings

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

Live Meetings

There are no Live Broadcasts available at this time.