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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

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

Meeting Details:

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

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

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

Meeting Details:

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

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 2/9/16-2/9/16

Meeting Details:

The committee will discuss biologics license application (BLA) 125544, for CT-P13, 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 White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 10/23/15-10/23/15

Meeting Details:

The committee will discuss new drug application (NDA) 207988, lesinurad oral tablets, submitted by Ardea Biosciences, Inc., for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor.

 

       
Location: FDA Meeting Room 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 OptionsArthritis & DSRM AdComm

Meeting Date: 2/10/14-2/11/14

Meeting Details:

The committees will discuss data and analyses published in 2006 or later that are relevant to further understanding the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 7/22/13-7/23/13

Meeting Details:

On July 22, 2013, the committee will discuss the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval. On July 23, 2013, during the morning session, the committee will discuss supplemental biologics license application (sBLA) 125057, HUMIRA (adalimumab) injection, by AbbVie Inc., for the proposed indication of reducing signs and symptoms in adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation by elevated C-reactive protein or magnetic resonance imaging, who have had an inadequate response to, or are intolerant to, a nonsteroidal anti-inflammatory drug. During the afternoon session, the committee will discuss sBLA 125160, certolizumab injection, by UCB, Inc., for the proposed indication of treatment of adult patients with active axial spondyloarthritis, including patients with ankylosing spondylitis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 12/20/12-12/20/12

Meeting Details:

The committee will discuss new drug application (NDA) 22151, rintatolimod injection (proposed trade name AMPLIGEN), submitted by Hemispherx Biopharma, Inc., for the treatment of patients with chronic fatigue syndrome.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee;

Meeting Date: 5/9/12-5/9/12

Meeting Details:

The committee will discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 5/8/12-5/8/12

Meeting Details:

The committee will discuss supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation of uric-acid lowering therapy in adult patients with gout. ARCALYST has not been studied for longer than 16 weeks in this clinical setting.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 3/12/12-3/12/12

Meeting Details:

The committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPostponed for a Later Date - Arthritis Advisory Committee

Meeting Date: 9/13/11-9/13/11

Meeting Details:

On September 13, 2011, the committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsILARIS by Novartis - Arthritis AdComm

Meeting Date: 6/21/11-6/21/11

Meeting Details:

On June 21, 2011, the committee will discuss supplemental biologics license application (sBLA) 125319, ILARIS (canakinumab), Novartis Pharmaceuticals Corporation, for the following proposed indication: "ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency of subsequent attacks."

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 11/16/10-11/16/10

Meeting Details:

The committee will discuss biologic license application (BLA) 125370, belimumab, proposed trade name BENLYSTA, sponsored by Human Genome Sciences, for the proposed indication of reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee and DSRM AdComm

Meeting Date: 8/20/10-8/20/10

Meeting Details:

On August 20, 2010, the committees will discuss new drug application (NDA) 22-531, sodium oxybate, 375 milligrams per milliliter (mg/ml) oral solution, sponsored by Jazz Pharmaceuticals, with a proposed indication for the treatment of fibromyalgia for patients 18 years of age and older . The safety and efficacy findings for sodium oxybate in the fibromyalgia population and the proposed Risk Evaluation and Mitigation Strategy (REMS) for this product will be discussed.

 

       
Location: Marriott - Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs and DSRM AdComm

Meeting Date: 5/12/10-5/12/10

Meeting Details:

On May 12, 2010, the committees will discuss new drug application (NDA) 22-478, naproxcinod0 375 milligram capsule, sponsored by NicOx S.A., a non-steroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 9/16/09-9/16/09

Meeting Details:

The committee will discuss biologics license application (BLA) 12-5338, clostridial collagenase, Auxilium Pharmaceuticals, Inc., for the proposed treatment of advanced Dupuytren's disease. Dupuytren's disease is a condition in which the tendons of the hand that help move the fingers of the hand become thickened and scarred.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 6/16/09-6/16/09

Meeting Details:

The committee will discuss biologics license application (BLA) 125293, KRYSTEXXA (pegloticase), Savient Pharmaceuticals, Inc., as a therapy for patients with refractory gout.

 

       
Location: Hilton Washington DC/Silver Spring Silver Spring, MD. Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPostponed: Arthritis AdComm

Meeting Date: 3/5/09-3/5/09

Meeting Details:

The committee will discuss biologics license application (BLA) 125293, pegloticase, Savient Pharmaceuticals, Inc., as a therapy for patients with treatment failure gout.

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 11/24/08-11/24/08

Meeting Details:

The committee will discuss new drug application (NDA) 21856, ULORIC (febuxostat), Takeda Pharmaceuticals North America, Inc., for the proposed treatment of hyperuricemia in patients with gout.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 7/29/08-7/29/08

Meeting Details:

The committee will discuss biologics license application (BLA) 125276, ACTEMRA (tocilizumab), Hoffman-La Roche, Inc., for the proposed treatment of adult patients with moderately to severely active rheumatoid arthritis.

 

       
Location: Hilton Washington DC/Silver Spring The Ballrooms 8727 Colesville Road Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 4/12/07-4/12/07

Meeting Details:

Agenda: The committee will discuss new drug application (NDA) 21-3891 21-772, ARCOXIA (etoricoxib), Merck & Co., Inc., proposed treatment for the relief of signs and symptoms of osteoarthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 11/29/06-11/29/06

Meeting Details:

The committee will discuss the safety and efficacy of the nonsteriodal anti-inflammatory drug (COX-2 inhibitor) new drug application (NDA) 20-998/S021, CELEBREX (celecoxib), Pfizer, Inc., for the proposed indication of the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 2 years and older.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs AdComm

Meeting Date: 9/6/05-9/6/05

Meeting Details:

The committee will discuss biologics license application (BLA) 125118/0, proposed trade name ORENCIA (abatacept), Bristol Myers Squibb, proposed indication for the treatment of moderately to severely active rheumatoid arthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCox-2 Joint Arthritis & Drug Safety Advisory Committee

Meeting Date: 2/16/05-2/18/05

Meeting Details:

The committees will discuss the overall benefit to risk considerations (including cardiovascular and gastrointestinal safety concerns) for COX-2 selective nonsteroidal anti-inflammatory drugs and related agents. FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005, which will provide for a full public discussion of these issues. Related Link From FDA

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 6/2/04-6/3/04

Meeting Details:

On June 2, 2004, the committee will discuss trial design and endpoints for drugs for chronic gout, including new drug application (NDA) 21-740, oxypurinol (proposed tradename, OXIPRIM), Cardiome. On June 3, 2004, the committee will discuss trial design and endpoints for drugs for acute gout, including NDA 21-389, etoricoxib (proposed tradename, ARCOXIA), Merck.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 9/29/03-9/30/03

Meeting Details:

On Both Days, the committee will discuss the purposed the systemic lupus arysmostos sle concept paper a prelimary discussion for creating a guidance document for the development of drugs biologics and devices for the treatment of SLE. On Sept 29 the committee will discuss the proposed sections regarding the current state of the art the claims for treatment and for clinical markers. On Sept 30 the committee will discuss the proposed section concerning trial design.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 6/23/03-6/24/03

Meeting Details:

On June 23, 2003, the committee will discuss fibromyalgia, clinical trial design, including important disease endpoints, in the study and development of therapies and treatments. On June 24, 2003, the committee will discuss the safety and efficacy of submission tracking number (STN) 103795/5123, Enbrel™ (etanercept), Immunex, for reducing signs and symptoms of active ankylosing spondylitis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 3/4/03-3/5/03

Meeting Details:

On March 4, 2003, the committee will hear a safety update on tnf alpha inhibitors; Humira (adalimumab), Abbott Laboratories; Remicade (infliximab) Centocor; and Enbrel (etanercept), Immunex. On March 5, 2003, the committee will discuss the approved product new drug application (NDA) 20-905, ARAVA, (leflunomide), Aventis Pharmaceuticals Inc., clinical data regarding efficacy for improvement in physical function in rheumatoid arthritis, as well as a safety update.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 7/29/02-7/30/02

Meeting Details:

On both days, the committee will discuss the clinical relevance of different classifications of pain as well as discussion of appropriate clinical trial models and designs for medications which would be indicated for each classification of pain.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 8/16/01-8/17/01

Meeting Details:

On August 16, the committee will discuss the efficacy and safety of submission tracking number (STN) 103950 Kineret (anakinra), Amgen, Inc., for reduction in signs and symptoms of active rheumatoid arthritis. On August 17, the committee will discuss safety update for Enbrel (etanercept), Immunex, and Remicade (infliximab), Centocor, for the treatment of rheumatoid arthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 4/19/01-4/19/01

Meeting Details:

On April 19, 2001, the committee will discuss new drug application (NDA) 21-239, Aslera (prasterone, Genelabs Technologies, Inc.) for improvement in disease activity and/or its symptoms in women with mild to moderate systemic lupus erythematosus (SLE) and reduction of corticosteroid requirements in women with mild to moderate SLE.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 2/7/01-2/9/01

Meeting Details:

On February 7, 2001, the committee will discuss new drug application (NDA) 20-998/S009, Celebrex (celecoxib, G. D. Searle & Co.) approved for the treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. The discussion is for modification of the label based on the results of the CLASS Trial, a study of the incidence of significant upper gastrointestinal effects. On February 8, 2001, the committee will discuss NDA 21-042/S007, VioxxTM (rofecoxib, Merck Research Laboratories) approved for the treatment of signs and symptoms of osteoarthritis and the management of acute pain. The discussion is for changes in the product label related to results of the VIGOR Trial concerning clinical gastrointestinal events. On February 9, 2001, the committee will discuss NDA 20-905/S006, AravaTM (leflunomide, Aventis) approved for the treatment of active rheumatoid arthritis. The discussion is for an indication to prevent disability as evidenced by improved physical function.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 7/12/00-7/12/00

Meeting Details:

The Committee will discuss biologics license application (BLA) 99-1234, Remicade TM (infliximab, Centocor) for the treatment of rheumatoid arthritis, prevention of radiographic progression and prevention of physical disability. The Committee will also discuss general issues regarding claims based on radiographic data in patients with rheumatoid arthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 4/11/00-4/11/00

Meeting Details:

The committee will discuss biologics license application 99-0884, Enbrel (etanercept, Immunex), for an indication in patients with early rheumatoid arthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 7/21/99-7/21/99

Meeting Details:

The Committee will discuss the evidence needed to establish that a drug product has a beneficial effect on joint structure in patients with osteoarthritis. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Holiday Inn Gaithersburg Walker and Whetstone Roo Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 4/20/99-4/20/99

Meeting Details:

The Committee will discuss the safety and efficacy of new drug application (NDA) 21-042 Vioxx™ (rofecoxib, Merck) for the treatment of acute or chronic signs and symptoms of osteoarthritis and the management of pain.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 2/23/99-2/23/99

Meeting Details:

The committee will discuss issues in the design and assessment of clinical trials of drugs, biologics, and devices that are being developed for treatment of systemic lupus erythematosus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 12/1/98-12/1/98

Meeting Details:

The Committee will discuss new drug application (NDA) 20-998 Celebrex™ (celecoxib, Searle) for the treatment of acute or chronic signs and symptoms of osteoarthritis and rheumatoid arthritis and the management of pain.

 

       
Location: Town Center Hotel The Maryland Ballroom 8727 Co Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 9/16/98-9/16/98

Meeting Details:

BLA 98-0286, Etanercept (EnbrelTM) Immunex.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 8/7/98-8/7/98

Meeting Details:

The committee will discuss the safety and efficacy of new drug application 20-905 Arava (leflunomide, Hoechst Marion Roussel, Inc., Germany) for the treatment of rhematiod arthritis.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 3/24/98-3/25/98

Meeting Details:

On March 24, the committee will discuss safety issues, gastrointestinal tolerability, renal, bone and reproductive toxicity related to nonsteroidal anti-inflammatory drugs, for example, COX-2 and other agents. On March 25, the committee will discuss the pain claim structure for chronic and acute pain and onset of pain relief including appropriate study design for prescription and nonprescription oral analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs

Meeting Date: 2/20/98-2/20/98

Meeting Details:

Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products Intended for the treatment of Osteoarthritis (OA)

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint meeting of the Nonprescription and the Arthritis Advisory Committee

Meeting Date: 7/15/97-7/15/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding New Drug Application (NDA) 20-802, Excedrin Extra Strength (acetaminophen, aspirin, caffeine) Tablets, Caplets, and Geltabs, 250 milligrams (mg), 250 mg, and 65 mg, respectively, Bristol Myers Squibb, for the pain of migraine.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 2/4/97-2/5/97

Meeting Details:

On February 4, 1997, the committee will hear presentations and discuss data submitted regarding the safety and efficacy of new drug application (NDA) 50-735, Neoral (cyclosporine, Sandoz) soft gelatin capsules and oral solution for microemulsion, for the treatment of severe rheumatoid arthritis. On February 5, 1997, the committee will review, discuss, and critique the draft document ``Guidance for Industry. Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),'' including Juvenile Rheumatoid Arthritis (JRA).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Nonprescription and the Arthritis Drugs Advisory Committee

Meeting Date: 10/9/96-10/9/96

Meeting Details:

The committees will discuss new drug application (NDA) 20-373, S+ Ibuprofen (dexibuprofen, Sterling Winthrop/Bayer) 200-milligram caplet, indicated for the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, back ache, menstrual cramps, minor pain of arthritis, and for the temporary reduction of fever for OTC status.

 

       
Location: n/a Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 5/7/96-5/7/96

Meeting Details:

The committee will hear presentations and discuss data submitted regarding the safety and efficacy of NDA 20- 395, Enable (tenidap sodium), Pfizer, Inc., for use in the treatment of rheumatoid arthritis and osteoarthritis.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 10/11/95-10/12/95

Meeting Details:

On October 11, 1995, the committee will consider issues presented in a citizen petition submitted by the Health Research Group of Public Citizen (Docket No. 94P-0458/CP1). The petition requests that FDA remove from the market drug products containing piroxicam, a nonsteroidal anti-inflammatory drug (NSAID), stating that the drug presents a significantly higher risk of gastropathy than other drugs in its class. The committee will examine safety data for the drug and advise FDA on whether piroxicam should be withdrawn from the market, whether changes in the drugs' labeling should be made, or whether no action need be taken. On October 12, 1995, the committee will examine the adequacy of the current gastropathy warnings in labeling for the class of NSAID's. Food Advisory Committee

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsArthritis Drugs Advisory Committee

Meeting Date: 7/14/95-7/14/95

Meeting Details:

On July 14, 1995, the Nonprescription Drugs Advisory Committee and the Arthritis Advisory Committee will discuss data relevant to NDA 20-499 (Bayer Corp.,) and NDA 20-429 (Whitehall-Robins Healthcare). Both NDA's are to switch ketoprofen (12.5 milligrams tablet/caplet) from prescription to over-the-counter status for the temporary relief of minor aches and pains associated with the common cold, toothache, muscular aches, backache, for the minor pain of arthritis, for the pain of menstrual cramps, and for reduction of fever.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Arthritis Drugs

Meeting Date: 3/27/95-3/28/95

Meeting Details:

During the morning of March 27, 1995, the Nonprescription Drugs Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee will discuss data relevant to new drug application (NDA) 18-751 to switch econazole nitrate cream 1% (Spectazole, Johnson & Johnson Consumer Products, Inc.) from prescription to OTC status for the treatment of tinea pedis (athlete's foot). During the afternoon of March 27, 1995, the Nonprescription Drugs Advisory Committee and representatives of the Pulmonary-Allergy Drugs Advisory Committee will discuss data relevant to the efficacy and use of antihistamines for the treatment of the common cold. In the morning on March 28, 1995, the Nonprescription Drugs Advisory Committee and the Arthritis Drugs Advisory Committee will discuss data relevant to NDA 20-512 for ibuprofen suspension (Motrin, McNeil Consumer Products) for the treatment of fever and of pain in children between 2 and 12 years of age. During the afternoon, the committees will discuss recommendations regarding appropriate OTC indication(s) for muscle relaxants, OTC dose(s) and duration of use, safety profiles, abuse potential, and pharmacokinetic information.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint OTC & Arthritis Drugs

Meeting Date: 9/8/94-9/9/94

Meeting Details:

On September 8 and 9, 1994, the joint subcommittee will discuss effectiveness data requirements and proposed labeling indications for OTC analgesic drug products. The joint subcommittee will address topics such as: (1) Data requirements to support specific types of indications for OTC analgesic drug products; (2) recommendations for labeling indications for OTC analgesics; and (3) the current state of scientific knowledge in the areas of pain receptors, mechanism(s) of pain perception, and the basis for response to analgesic drug classes.

 

       
Location: September 8 and 9, 1994, 8:30 a.m., Parklawn Bldg., conference rms. D and E, 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 OptionsOncologic Drugs AdComm

Meeting Date: 7/11/17-7/13/17

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Meeting Details:

During the morning session, the committee will discuss biologics license application (BLA) 761028 for ABP 215, a proposed biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), submitted by Amgen Inc. The proposed indications/uses for this product are: (1) For the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy; (2) in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line ABP 215-containing regimen; (3) for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent; (5) for the treatment of metastatic renal cell carcinoma in combination with interferon alfa; and (6) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix. During the afternoon session, the committee will discuss biologics license application (BLA) 761074 for MYL-1401O, a proposed biosimilar to Genentech Inc.’s HERCEPTIN (trastuzumab), submitted by Mylan GmbH. The proposed indications/uses for this product are: (1) For adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; (a) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; (b) with docetaxel and carboplatin; or (c) as a single agent following multi-modality anthracycline based therapy; (2) in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; (3) as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and (4) in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 7/28/17-7/28/17

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Meeting Details:

On July 28, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 6/21/17-6/22/17

Meeting Details:

On June 21, 2017, information will be presented to gauge investigator interest in exploring potential pediatric development plans for three 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) APX-005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; and (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. On June 22, 2017, 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) Prexasertib, presentation by Dista Products/Eli Lilly and Company and (2). olaratumab, presentation by Eli Lilly and Company.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 6/20/17-6/20/17

Meeting Details:

The committee will discuss a supplemental new drug application for VICTOZA (liraglutide) injection (sNDA 022341), sponsored by Novo Nordisk, for the proposed additional indication of: As an adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 5/24/17-5/25/17

Meeting Details:

On May 24th during the morning session, the committee will discuss new drug application (NDA) 208051, for neratinib maleate, an application submitted by Puma Biotechnology. The proposed indication (use) for this product is as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant traustuzumab-based therapy. During the afternoon session, the committee will discuss NDA 208587, for L-glutamine powder (oral solution), submitted by Emmaus Medical, Inc. The proposed indication (use) for this product is for the treatment of sickle cell disease. On May 25th the committee will discuss biologics license application (BLA) 125545, for a proposed biosimilar to Amgen Inc.'s Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company. The proposed indications/uses for this product are: (1) For the treatment of anemia due to chronic kidney disease, including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion; (2) for the treatment of anemia due to zidovudine administered at = 4,200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of = 500 m units/mL; (3) for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and (4) to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to <13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, and nonvascular surgery.

 

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

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Past Meetings

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