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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm - Drug Name: OxyContin

Meeting Date: 9/26/19-9/26/19

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Meeting Details:

On September 26, 2019, the Pediatric Advisory Committee (PAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee will meet to discuss the pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets, as mandated by the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), and to discuss pediatric data considerations for opioid analgesics labeling and Pediatric Research Equity Act studies for opioids generally, using Opana IR as an example.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm - Drug Name: Singulair

Meeting Date: 9/27/19-9/27/19

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Meeting Details:

On September 27, 2019, the Pediatric Advisory Committee (PAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee will meet to discuss a pediatric-focused safety review of neuropsychiatric events with use of Singulair (montelukast).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-2:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs AdComm - Sponsor: Shionogi Inc.

Meeting Date: 10/16/19-10/16/19

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Meeting Details:

The committee will discuss new drug application (NDA) 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic AdComm - Sponsor: Agile Therapeutics, Inc.

Meeting Date: 10/30/19-10/30/19

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Meeting Details:

The committee will discuss new drug application (NDA) 204017 (levonorgestrel and ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc., for the prevention of pregnancy in women of reproductive potential.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 11/6/19-11/7/19

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Meeting Details:

On November 6 and 7, 2019, the committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. Subject matter of the panel meeting will include potential methods and expert assessment of how to reduce EtO emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing of medical devices. The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes.

 

       
Location: Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

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

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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    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm - Sponsor: GlaxoSmithKline

Meeting Date: 9/18/19-9/18/19

Meeting Details:

The committee will discuss data submitted by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, to support new drug application (NDA) 208425, for over-the-counter (OTC) marketing of nicotine oral spray (1 milligram (mg) per spray). The proposed OTC use is to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. The applicant proposes to label the product for adults 18 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of nicotine oral spray (1 mg per spray) by OTC consumers.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm - Sponsor: Aimmune Therapeutics, Inc

Meeting Date: 9/13/19-9/13/19

Meeting Details:

On September 13, 2019, the Center for Biologics Evaluation and Research's (CBER) Allergenic Products Advisory Committee (APAC) will meet in open session to discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Aimmune Therapeutics, Inc, indicated for treatment to reduce the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement Advisory Committee

Meeting Date: 9/10/19-9/10/19

Meeting Details:

On September 10, 2019, the Committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.” Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients. These same features may also increase cybersecurity risks. Preserving the benefit of these devices requires continuous vigilance as well as timely and effective communication to medical device users about evolving cybersecurity risks. The recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication. The recommendations will also address concerns patients have about changes to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Past Meetings

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