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U.S. FDA advisory meetings through May 12
Wed, 10th Mar 2010 18:08
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL ITEMS AFTER MARCH 13 ARE EDT/GMT.
For more information on the FDA's Advisory Committee meetings, see: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Adds April 14 pharmaceutical science meeting)
JOINT MEETING OF THE PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE: March 10-11, 0800/1300
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss the design of medical research studies to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the use of the class of asthma medications known as long acting beta-2 adrenergic agonists in the treatment of asthma in adults, adolescents, and children.
NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: March 12, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Deborah Falls, 301-796-5620
The committee will discuss, make recommendations, and vote on use of Medtronic Inc's Deep Brain Stimulation (DBS) Therapy for as an adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. The device is already approved for use in patients with Parkinson's disease and essential tremor.
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY
DATE: March 17, 0730/1130
LOCATION: Marriott Marquis, 265 Peachtree Center Ave., Atlanta, Ga.
CONTACT: Yvette Waples, 301-827-7001
The committee will discuss and provide comments on the following topics: general scientific issues related to the application of pharmacogenomics in the early stages of drug development; a new patient-centric clinical pharmacology approach to drug safety; the design and analysis of clinical pharmacology studies focusing on how the renal function changes in the way the body absorbs, distributes, metabolizes, and excretes a drug in patients with kidney impairment; and scientific considerations and recent developments in transporter-mediated drug interactions. These interactions are between two or more drugs that either inhibit or enhance the roles of specialized proteins known as transporters and, in turn, the interactions can affect a drug's safety and/or efficacy.
CIRCULATORY SYSTEMS DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: March 18-19, 0800/1200
LOCATION: Holiday Inn, 10000 Baltimore Ave., College Park, Md.
CONTACT: James Swink, 301-796-6313
On March 18, the committee will discuss, make recommendations, and vote on the premarket approval application for Cardiac Resynchronization Therapy Defibrillators (CRTDs) sponsored by Boston Scientific. The sponsor is seeking expanded indications for CRTDs to include patients with low left ventricular ejection fraction and wide QRS who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology).
On March 19, the committee will discuss, make recommendations and vote on a premarket approval application for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard pacing indication) that has been specifically designed to be safe for the MRI environment under certain MR scanning conditions.
Keywords: FDA ADVISORY/DIARY
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
For more information on the FDA's Advisory Committee meetings, see: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Adds April 14 pharmaceutical science meeting)
JOINT MEETING OF THE PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE: March 10-11, 0800/1300
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss the design of medical research studies to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the use of the class of asthma medications known as long acting beta-2 adrenergic agonists in the treatment of asthma in adults, adolescents, and children.
NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: March 12, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Deborah Falls, 301-796-5620
The committee will discuss, make recommendations, and vote on use of Medtronic Inc's Deep Brain Stimulation (DBS) Therapy for as an adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. The device is already approved for use in patients with Parkinson's disease and essential tremor.
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY
DATE: March 17, 0730/1130
LOCATION: Marriott Marquis, 265 Peachtree Center Ave., Atlanta, Ga.
CONTACT: Yvette Waples, 301-827-7001
The committee will discuss and provide comments on the following topics: general scientific issues related to the application of pharmacogenomics in the early stages of drug development; a new patient-centric clinical pharmacology approach to drug safety; the design and analysis of clinical pharmacology studies focusing on how the renal function changes in the way the body absorbs, distributes, metabolizes, and excretes a drug in patients with kidney impairment; and scientific considerations and recent developments in transporter-mediated drug interactions. These interactions are between two or more drugs that either inhibit or enhance the roles of specialized proteins known as transporters and, in turn, the interactions can affect a drug's safety and/or efficacy.
CIRCULATORY SYSTEMS DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: March 18-19, 0800/1200
CONTACT: James Swink, 301-796-6313
On March 18, the committee will discuss, make recommendations, and vote on the premarket approval application for Cardiac Resynchronization Therapy Defibrillators (CRTDs) sponsored by Boston Scientific. The sponsor is seeking expanded indications for CRTDs to include patients with low left ventricular ejection fraction and wide QRS who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology).
On March 19, the committee will discuss, make recommendations and vote on a premarket approval application for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard pacing indication) that has been specifically designed to be safe for the MRI environment under certain MR scanning conditions.
Keywords: FDA ADVISORY/DIARY
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
