FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Order Webcast

    Purchasing > Arthritis Drugs AdComm Meeting

Single Viewer Webcast
Description: Allows for a single viewer (1 person/1 PC) to view the webcast on their desktop.

Group Webcast
Description: Allows for fullscreen viewing (1 Single Feed) for a meeting room or auditorium.

Meeting Date: 07/22/13

Time: 8:00AM-4:00PM

Price: $140.00

Meeting Date: 07/22/13

Time: 8:00AM-4:00PM

Price: $800.00

Meeting Date: 07/23/13

Time: 8:00AM-5:30PM

Price: $140.00

Meeting Date: 07/23/13

Time: 8:00AM-5:30PM

Price: $800.00

Webcast / System Compatibility Test - Please be sure to view a webcast test before purchase



System Requirements: Windows PC or MAC with Sound Card/Speakers, Windows Media Player 7 or above and A Broadband Internet Connection. Best viewed on hard-wired network unless using Wireless-N.


To download Windows Media Player click here. If you need further assistance contact FDALive Tech Support at techsupport@fdalive.com and a representative will contact you.

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 12/13/19-12/13/19

.

Meeting Details:

The committee will discuss biologics license application (BLA) 761143, teprotumumab solution for intravenous use, submitted by Horizon Pharma Ireland, Ltd., proposed for the treatment of active thyroid eye disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 12/17/19-12/18/19

.

Meeting Details:

17th AM Session, the committee will discuss supplemental new drug application (sNDA) 208558/010 for LYNPARZA (olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic adenocarcinoma of the pancreas whose disease has not progressed on first-line platinum-based chemotherapy.

17th PM Session, the committee will discuss supplemental biologics license application (sBLA) 125514/066 for KEYTRUDA (pembrolizumab) for injection, submitted by Merck Sharpe & Dohme Corp. The proposed indication (use) for this product is for the treatment of patients with bacillus Calmette-Guérin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

18th AM Session, the committee will discuss biologics license application (BLA) 761136/Original 2, for luspatercept for injection, application submitted by Celgene Corporation. The proposed indication (use) for this product is for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes -associated anemia who have ring sideroblasts and require red blood cell transfusions.

18th PM Session, the committee will discuss new drug application (NDA) 211723 for tazemetostat tablets, submitted by Epizyme, Inc. The proposed indication (use) for this product is for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products and DSRM AdComm

Meeting Date: 1/14/20-1/14/20

.

Meeting Details:

The committees will discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products and DSRM AdComm

Meeting Date: 1/15/20-1/15/20

.

Meeting Details:

During the morning session, the committees will discuss new drug application (NDA) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

During the afternoon session, the committees will discuss NDA 209653, for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these 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, as well as to discuss the overall risk-benefit profile of the product.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 1/16/20-1/16/20

.

Meeting Details:

The committee will discuss new drug application (NDA) 204803, bupivacaine extended-release solution for instillation, submitted by DURECT Corp., for the proposed indication of post-surgical analgesia. The committee will discuss whether the Applicant adequately demonstrated the safety and efficacy of bupivacaine extended-release solution for post-surgical analgesia and the appropriateness of the proposed patient populations. The committee will also be asked to discuss the approvability of this product.

 

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

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/10/19-12/10/19

Meeting Details:

The committee will be asked to discuss new drug application (NDA) 022034, for vernakalant HCl solution, for intravenous injection, submitted by Correvio International Sàrl, for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients: Atrial fibrillation = 7 days duration, and for post-cardiac surgery patients: Atrial fibrillation = 3 days duration.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 11/22/19-11/22/19

Meeting Details:

On November 22, 2019, the BPAC will meet in open session to discuss scientific considerations for cold stored platelet products intended for transfusion, including product characterization, duration of storage and clinical indications for use. The committee will hear presentations on available characterization and functional studies of cold stored platelets, clinical studies, and the potential role of cold stored platelets in clinical care in military and civilian patient populations. The committee will also discuss the clinical studies needed to support the indications for use of cold stored platelet products stored beyond 3 days.

 

       
Location: Tommy Douglas Conference Center 10000 New Hampshire Ave Silver Spring, MD 20993 Related News Links: Not Available
Time: 8:30AM-4:45AM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Amarin Pharma Inc.

Meeting Date: 11/14/19-11/14/19

Meeting Details:

The committee will discuss supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)”

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/13/19-11/14/19

Meeting Details:

On November 13 and 14, 2019, the committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically, greater than 30 days). For decades, metal-containing implants have been used in a large number of medical specialties including cardiology, orthopedics, dentistry, gastroenterology, and neurology or neurosurgery. Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local (peri-implant) adverse events and potentially systemic manifestations, which may impact a patient's quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Boehringer Ingelheim

Meeting Date: 11/13/19-11/13/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: As an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-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.