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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drugs AdComm

Meeting Date: 4/22/14-4/22/14

Meeting Details:

The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

 

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

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Meeting OptionsMeeting OptionsMeeting Options*** Cancelled *** Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 7/17/13-7/18/13

Meeting Details:

The committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at three minutes after administration of rocuronium.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug AdComm

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

Meeting Details:

The committee will discuss the risks and benefits of new drug application (NDA) 202880, by Zogenix Inc., for hydrocodone bitartrate extended-release capsules (proposed tradename ZOHYDRO ER), an opioid analgesic medication for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This formulation of hydrocodone bitartrate extended-release capsules represents the first single-entity (i.e., containing no other active pharmaceutical ingredients, such as acetaminophen or ibuprofen) hydrocodone-containing drug product. It will be formulated in dose strengths up to 50 milligrams, and administered twice daily (i.e., every 12 hours). The committee will be asked to determine whether the benefit-risk assessment of this product favors its approval for marketing.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 2/9/12-2/9/12

Meeting Details:

The committee will discuss the available efficacy and safety data for supplemental new drug application (sNDA) 22395/S–013, QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy (nerve pain in the periphery of the body, such as the feet and legs).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 3/10/11-3/10/11

Meeting Details:

On March 10, 2011, the committee will: (1) Receive updates regarding neurodegenerative findings (findings related to degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results from human epidemiological studies using anesthesia in children (information related to studies of patterns and causes of disease); (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies; and (3) discuss the potential implications of these data upon the practice of pediatric anesthesia as well as the communication of the risk of sedative/anesthetic agents to prescribers and parents.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs /DSRM AdComm

Meeting Date: 10/21/10-10/22/10

Meeting Details:

The committee will discuss considerations for the design of postmarketing studies for new drug application (NDA) 22-272 , OxyContin (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma, Inc. and NDA 22-321 Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, Alpharma Pharmaceuticals, LLC and King Pharmaceuticals Research & Development, Inc., approved for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The postmarketing studies are intended to be epidemiological or observational studies that will assess the known serious risks of these products and whether product-specific properties which are intended to deter misuse and abuse actually result in a decrease in the risks of misuse and abuse, and their consequences: addiction, overdose, and death.

 

       
Location: Hilton Washington DC/North Gaithersburg 620 Perry Parkway Gaithersburg, Maryland Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 8/19/10-8/19/10

Meeting Details:

On August 19, 2010, the committee will discuss the available safety and efficacy data for new drug application (NDA) 22516, CYMBALTA (duloxetine HCL) Capsules, by Eli Lilly and Co., as it relates to the proposed indication of treatment of chronic pain.

 

       
Location: Bethesda Marriott The Ballrooms 5151 Pooks Hill Rd. Bethesda, MD. Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Life Support and DSRM AdComm

Meeting Date: 7/22/10-7/23/10

Meeting Details:

The committees will discuss Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics. As a part of the materials for the meeting, FDA anticipates presenting a proposal for a class-wide opioid REMS and will solicit feedback from the advisory committees and public on the components of that proposal. The need for adequate pain control is an element of good medical practice. In this context, some persons suffering from pain need access to potent opioid drug products; however, inappropriate prescribing, addiction and death due to prescription opioid abuse and misuse have been increasing over the last decade.

 

       
Location: The Marriott Inn and Conference Center, Adelphi, MD. Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support & DSRM AdComm

Meeting Date: 4/22/10-4/22/10

Meeting Details:

The committees will discuss new drug application (NDA) 22-451 ACUROX (oxycodone HCl and niacin) Tablets, Acura Pharmaceuticals, Inc., for the proposed indication of relief of moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic tablet is appropriate, and the results of studies evaluating the addition of niacin, added for the purpose of reducing the misuse of oxycodone.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm - Eli Lilly Meeting Cancelled

Meeting Date: 1/28/10-1/28/10

Meeting Details:

On January 28, 2010, the committee will discuss the available safety and efficacy data for new drug application (NDA) 22516, CYMBALTA (duloxetine HCL) Capsules, by Eli Lilly and Co., as they relate to the proposed indication of treatment of chronic pain.

 

       
Location: Hilton Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs/DSRM AdComm

Meeting Date: 9/24/09-9/24/09

Meeting Details:

The committees will discuss new drug application (NDA) 22272, OXYCONTIN (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma L.P., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. This formulation was previously reviewed and discussed by these committees on May 5, 2008, and will be considered again in light of new data.

 

       
Location: Holiday Inn Gaithersburg MD Related News Links: Not Available
Time: 9:15AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs/DSRM AdComm

Meeting Date: 9/23/09-9/23/09

Meeting Details:

The committees will discuss new drug application (NDA) 21217, EXALGO (hydromorphone HC1), Neuromed Pharmaceuticals, Inc., a modified-release hydromorphone drug product indicated for the treatment of moderate-to-severe pain in opioid-tolerant patients.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support /DSRM AdComm

Meeting Date: 1/30/09-1/30/09

Meeting Details:

The committee will discuss the available safety and efficacy data for all propoxyphene-containing products (including hydrochloric acid (HCl), napsylate salts, and combination drugs) and whether any regulatory action is appropriate.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support and DSRM AdCOmm

Meeting Date: 11/13/08-11/14/08

Meeting Details:

On November 13 and 14, 2008, the committees will begin with a closed session, from 8 a.m. to 9:15 a.m. Following the closed session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to the public. On November 13, 2008, the committees will discuss new drug application (NDA) 22324, REMOXY XRT (oxycodone hydrochloride controlled-release) Capsules, Pain Therapeutics Inc., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled-release characteristics of this formulation are purportedly less easily defeated than other formulations of controlled-release oxycodone. On November 14, 2008, the committees will discuss new drug application NDA 22321, EMBEDA (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, Alpharma Pharmaceuticals L.L.C., and its safety for the proposed indication of management of moderate to severe chronic pain. The naltrexone component of this formulation is intended to mitigate abuse of the product when attempts are made to defeat the controlled-release properties of the formulation.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 5/7/08-5/7/08

Meeting Details:

On May 7, 2008, the committee will discuss new drug application (NDA) 22–244, fospropofol disodium injection (35 milligrams/milliliter) (proposed tradename Aquavan), MGI Pharma, Inc., for the proposed indication of sedation in adult patients undergoing diagnostic or therapeutic procedures.

 

       
Location: Holiday Inn - The Ballrooms Two Montgomery Village Avenue Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Anesthetic-Life and DSRM AdComm

Meeting Date: 5/5/08-5/6/08

Meeting Details:

On May 5, 2008, the committees will discuss new drug application (NDA) 22–272, OXYCONTIN (oxycodone hydrochloride controlled-release) Tablets, Purdue Pharma L.P., and its safety for the proposed indication of management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The sustained-release characteristics of this formulation are purportedly less easily defeated than other formulations of OXYCONTIN. On May 6, 2008, the committees will discuss supplemental new drug application (sNDA) 21–947/ s-005, FENTORA (fentanyl buccal tablet), Cephalon, Inc., and its safety for the proposed indication of breakthrough pain in opioid tolerant non-cancer patients with chronic pain.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 3/11/08-3/11/08

Meeting Details:

The committee will discuss the new drug application [NDA) 22-225, sugammadex sodium injection (proposed tradename BRIDION), Organon USA Inc., for the proposed indication of routine reversal of shallow and profound neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at three minutes after administration of rocuronium.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs AdComm

Meeting Date: 3/29/07-3/29/07

Meeting Details:

The committee will do the following: (1) Receive presentations regarding neurodegenerative findings in juvenile animals exposed to anesthetic drugs (e.g., ketamine); and (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 11/18/03-11/19/03

Meeting Details:

On November 18, 2003: the committee will discuss the assessment and management of risk related to QTc prolongation by Droperidol (Inapsine) Akorn, Inc., indicated for nausea and vomiting in surgical and diagnostic procedures, premedication, and neuroleptanalgesia.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 9/9/03-9/10/03

Meeting Details:

On September 9, 2003, the committee will discuss Risk Management Plans for opiate analgesic drug products with particular attention to modified-release products. On September 10, 2003, the committee will discuss the abuse liability of and Risk Management Plans for Palladone, a modified-release hydromorphone drug product indicated for the treatment of moderate to severe pain in opioid tolerant patients.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs Advisory Committee

Meeting Date: 5/16/02-5/16/02

Meeting Details:

The committee will discuss Specific Issues in development of pharmaceuticals for the treatment of neuropathy and neuropathic pain. Other area's of discussion include Duration of clinical trials, Evaluation of nerve function, Electrophysiological endpoints and general / specific claims.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 1/30/02-1/31/02

Meeting Details:

On both days, the committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk to benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory

Meeting Date: 9/13/01-9/14/01

Meeting Details:

On both days, the committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk to benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory

Meeting Date: 6/14/01-6/15/01

Meeting Details:

On both days the committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk to benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs

Meeting Date: 1/12/99-1/12/99

Meeting Details:

The committee will hear presentations and discuss the cardiovascular safety data submitted regarding new drug application (NDA) 20-997, Chirocaine (levobupivacaine injection), Darwin Discovery Ltd., a local anesthetic agent indicated for surgical anesthesia and pain management.

 

       
Location: FDA Building Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs

Meeting Date: 2/5/98-2/5/98

Meeting Details:

Organon Inc. - Orgaran (danaparioid sodium) Injection Pharmacia & Upjohn - Prevention of Perioperative Thromboembolic Complications with Low Molecular Weight Heparins in Patients Receiving Epidural/Spinal Anesthesia: Risk/Benefit Considerations - Experience with Fragmin Rhone-Polenc Rorer - Lovenox (enoxaparin sodium) Injection Wyeth Laboratories - Normiflo (adreparin sodium) Injection

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 9/17/97-9/17/97

Meeting Details:

The committee will hear presentations and discuss data submitted regarding new drug application (NDA) 20-747, ActiqTM (oral transmucosal fentanyl citrate, drug matrix on a handle), Anesta Corp., for the management of chronic pain, particularly breakthrough pain, in patients who are already receiving and are tolerant to opioid therapy.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 12/18/96-12/18/96

Meeting Details:

The committee will discuss labeling for NDA 18-654, Versed (midazolam HC1), Hoffmann La-Roche, for pediatric sedation.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Life Support Drugs Advisory Committee

Meeting Date: 4/29/96-4/30/96

Meeting Details:

The committee will discuss the new drug application (NDA) 20-630, Remifentanyl, Glaxo Welcome, for use as a general anesthetic, and a report of the post-market experience and phase IV commitments of NDA 20-478, Ultane (sevoflurane), Abbott Laboratories.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs Advisory Committee

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

Meeting Details:

The committee will discuss the new drug application (NDA) 20-533, Naropin , Astra Laboratories, for use as a local anesthetic and a report of the postmarket surveillance of NDA 27-428, Oralet, Anesta.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs

Meeting Date: 1/17/95-1/17/95

Meeting Details:

Sevorane

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Life Support Drugs

Meeting Date: 6/9/94-6/9/94

Meeting Details:

On June 9, 1994, the committee will discuss: (1) The labeling of succinylcholine chloride injection (neuromuscular blocking agent) new drug applications (NDA's) 8-453, Burroughs Wellcome and Co.; 8-845, Abbott Laboratories; 8-847, Bristol- Myers Squibb Co.; and 80-997, Organon, Inc.; and (2) adverse experience associated with the administration of 5 percent lidocaine for spinal anesthesia, NDA 20-098/S-04, Astra Pharmaceutical Products, Inc. On June 10, 1994, the committee will hear a progress report on the metabolism of lidocaine by human liver tissues.

 

       
Location: 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 OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 4/24/14-4/24/14

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Meeting Details:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).

 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 5/2/14-5/2/14

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Meeting Details:

The committee will discuss data submitted by MSD Consumer Care, Inc., to support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. Efficacy and safety data, as well as results of consumer studies, will be discussed. The committee will be asked to consider whether the data support an acceptable risk/benefit profile for the nonprescription use of montelukast tablets by OTC consumers.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 5/5/14-5/6/14

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Meeting Details:

On May 5-6, 2014, the Committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates (http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm disclaimer icon ) are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. The discussion will also assess whether the communications are having the intended impact on knowledge, behaviors and/or outcomes.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/6/14-5/7/14

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Meeting Details:

On May 6, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during manual cardiopulmonary resuscitation (CPR) in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest. Advanced Circulatory Systems, Inc. has proposed the following indications for use: the RESQCPR System is intended for use in the performance of CPR to increase survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest. On May 7, 2014, during session I, the committee will discuss and make recommendations regarding the classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendment Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is currently used for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/13/14-5/13/14

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Meeting Details:

On May 13, 2014, the committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories.

 

       
Location: Holiday Inn Germantown, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 6/17/14-6/17/14

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Meeting Details:

On June 17, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the Maestro® Rechargeable System sponsored by Enteromedics, Inc. The Maestro® Rechargeable System provides VBLOC Therapy. The implantable device is a neuromodulator, which delivers high frequency (5000 Hertz), controllable electrical pulses to the intra-abdominal vagus nerve trunks. The effect of VBLOC therapy is reported to suppress neural signals carried by the vagus nerve trunks, resulting in decreased hunger pangs, decreased digestive enzyme secretion and calorie absorption, and increased satiety. The device consists of implantable electronic device components that deliver VBLOC therapy, and external components that regulate device performance. The proposed indication for use for the Maestro® Rechargeable System, as stated in the PMA, is as follows: The Maestro® Rechargeable System is indicated for use in weight reduction in adult patients with obesity that have a Body Mass Index (BMI) of at least 40 kilograms per square meter (kg/m2), or a BMI of at least 35 kg/m2 with one or more obesity related comorbid conditions, and have failed a more conservative weight reduction alternative.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Adcomm

Meeting Date: 6/25/14-6/25/14

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Meeting Details:

he committee will discuss new drug application (NDA) 206162, olaparib capsules, application submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drugs AdComm

Meeting Date: 4/22/14-4/22/14

Meeting Details:

The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/21/14-4/21/14

Meeting Details:

On April 21, 2014, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107–109) and the Pediatric Research Equity Act (Pub. L. 108–155). The PAC will meet to discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor (recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), and VIREAD (tenofovir disoproxil fumarate).

 

       
Location: Bethesda Marriott 5151 Pooks Hill Road Bethesda, MD 20814 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: 4/1/14-4/1/14

Meeting Details:

The committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/31/14-3/31/14

Meeting Details:

During the morning session, the committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections. During the afternoon session, the committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 3/27/14-3/27/14

Meeting Details:

The committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMolecular and Clinical Genetics Panel

Meeting Date: 3/26/14-3/27/14

Meeting Details:

On March 26, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application sponsored by Epigenomics, Inc. for the Epi proColon. The Epi proColon test is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens. Methylation of the target Septin 9 DNA sequence has been associated with the occurrence of colorectal cancer (CRC). The test is indicated to screen patients for CRC who are defined as average risk for CRC by current screening guidelines. The Epi proColon test is not intended to replace colorectal screening by colonoscopy. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results are intended to be used in conjunction with the physician's assessment of history, other risk factors, and professional guidelines. On March 27, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Cologuard device, sponsored by Exact Sciences. Cologuard is an in vitro diagnostic device designed to analyze patients' stool for detection of hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA. Cologuard is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer or premalignant colorectal neoplasia. Cologuard is not intended as a replacement for colonoscopy. Cologuard is intended to be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Past Meetings

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

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