Monday November 2, 06:34 PM
U.S. FDA advisory meetings through Dec. 18
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EST/GMT.
For more information on the FDA's Advisory Committee meetings, see: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Adds Dec 11 urology devices meeting, Dec. 18 hearing device meeting, postponement of Nov. 20 meeting; Amends Dec. 8 pediatric drugs meeting)
ORTHOPAEDIC AND REHABILITATION DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Nov 4, 0800/1300
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg Md.
CONTACT: Ronald Jean, 301-796-5650
The committee will discuss, make recommendations and vote on a premarket approval application for the Dynesys Spinal System, sponsored by Zimmer Holdings Inc. The Dynesys Spinal System is indicated to provide spinal alignment and stabilization in skeletally mature patients at one or two contiguous levels from L1S1.
BLOOD PRODUCTS ADVISORY COMMITTEE
DATE: Nov 16 and 17, 0800/1300
LOCATION: Marriott, 5151 Pooks Hill Rd., Bethesda, Md.
CONTACT: William Freas or Pearline Muckelvene, 301-827-0314
On Nov, 16, the committee will hear updates on the HHS Advisory Committee on Blood Safety and Availability, Dengue virus outbreak, 2009 A/H1N1 Pandemic and the impact on blood safety and availability, and blood donor deferral for malaria risk associated with travel to Mexico. In the afternoon, the committee will discuss the design of a new phase III study of pathogen inactivation of human platelets using the Cerus Corp's INTERCEPT Blood System.
On Nov. 17, the committee will discuss blood pressure and pulse as blood donor eligibility criteria, followed by an afternoon discussion on the public health need and performance characteristics of over-the-counter home-use HIV test kits.
RADIOLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Nov 17-18, 0800/1300
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Toby Lowe, 301-796-6512
On Nov. 17, the committee will discuss and make recommendations regarding the agency's regulatory strategy for Full Field Digital Mammography Devices. The committee will discuss the public comments received in response to the publication of the draft guidance document titled Class II Special Controls Guidance Document: Full Field Digital Mammography System.
On Nov. 18, the committee will discuss and make recommendations regarding the agency's regulatory strategy for computer-assisted detection (CADe) devices for radiological devices. CADe devices are devices intended to identify, mark, highlight or in any other manner direct attention to potential abnormalities revealed in radiological data of the human body or imaging device data during interpretation of patient images or patient imaging data by a physician or other healthcare professional. The committee will discuss two draft guidance documents titled Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data Premarket Notification Submissions and Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device DataPremarket Approval (PMA) and Premarket Notification Submissions.
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE
DATE: Nov 18, 0800/1300
LOCATION: Hilton, 8727 Colesville Rd., Silver Spring, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss Genentech (NYSE: DNA - news) and Novartis Pharmaceuticals Corp.'s Xolair, also known as omalizumab, to treat moderate to severe persistent asthma in children ages six to 11 whose symptoms are not controlled with inhaled steroid medications. Patients would have to have a positive skin test reaction to pollen or other common substances that can cause allergies and asthma or blood test results that confirm the presence of certain proteins linked to allergies and asthma. Genentech is a unit of Roche (Virt-X: ROG.VX - news) .
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
DATE: Nov 18, 0800/1300 and Nov 19, 0800/1300
LOCATION: Marriott, 5151 Pooks Hill Rd., Bethesda, Md.
CONTACT: Christine Walsh or Denise Royster, 301-827-0314
On Nov 18, the committee will discuss and make recommendations on the safety and effectiveness of a Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein). It will also hear an update on FDA's Influenza A (H1N1) 2009 monovalent vaccine activities.
On Nov 19, the committee will discuss and make recommendations on the safety and effectiveness of an influenza vaccine known as purified recombinant influenza hemagglutinin.
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE
DATE: Nov 19, 0800/1300
LOCATION: Hilton, 8727 Colesville Rd., Silver Spring, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss the efficacy supplement for Boehringer Ingelheim and Pfizer Inc's already-approved Spiriva HandiHaler, a tiotropium inhalation powder, to help prevent symptoms from getting worse in patients with chronic obstructive pulmonary disease, or COPD. Keywords: FDA ADVISORY/DIARY
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE
DATE: Nov 20, 0800/1300
LOCATION: Hilton, 8727 Colesville Rd., Silver Spring, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss Pharmaxis Ltd's Aridol lung test for use in assessing airway irritability in the lungs, also known as bronchial hyperresponsiveness. The product aims to help diagnose patients at least 6-years-old of age who have symptoms of asthma or symptoms that are suggestive of asthma.
POSTPONED
NEUROLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Nov 20, 0800/1300
LOCATION: Holiday Inn, Two Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Deborah Falls, 301-796-6459
The committee will discuss potential approval of Medtronic Inc's Deep Brain Stimulation System as an adjunctive therapy for reducing the frequency of seizures in epilepsy patients.
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
DATE: Dec 7, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Elaine Ferguson, 301-827-7001
The committee will discuss new drug application from Novartis Pharmaceuticals for everolimus oral tablets to be used in patients with kidney transplants to prevent rejection of the transplanted kidney.
JOINT MEETING OF THE CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE: Dec 8, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Elaine Ferguson, 301-827-7001
The committee will discuss safety considerations related to FDA-approved gadolinium-based contrast agents used with magnetic resonance imaging (MRI) scans. Contrast agents are substances injected into the body before MRI scans, helping doctors to better see and interpret MRI findings. FDA approved gadolinium-based contrast agents include Bracco Diagnostics' Multihance (gadobenate dimeglumine) and Prohance (gadoteridol), GE Healthcare's Omniscan (gadodiamide), Bayer AG (Xetra: 575200 - news) 's Magnevist (gadopentetate dimeglumine) and Eovist (gadoxetate disodium), Covidien (Frankfurt: A0RNL3 - news) 's Optimark (MLOPM.NX - news) (gadoversetamide), and Lantheus Medical Imaging's Ablavar (gadofosveset, formerly known as Vasovist).
ADDS DETAILS ON ANTIPSYCHOTIC DRUGS, REMOVES 2 OTHERS
PEDIATRIC ADVISORY COMMITTEE
DATE: Dec 8, 0800/1300
LOCATION: Hilton, 1750 Rockville Pike, Rockville, Md.
CONTACT: Doreen Kezer, 301-827-1249
The committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Bristol-Myers Squibb Co's Abilify, Orencia and Reyataz; GlaxoSmithKline's Argatroban and Ventolin HFA; Abbott Laboratories Inc's Humira and Kaletra; Merck & Co's Cancidas; Johnson & Johnson's Evicel fibrin sealant (human), Baxter International Inc's Artiss fibrin sealant (human), Fresenius (Xetra: 578560 - news) ' Voluven 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection; Boehringer Ingelheim's Aptivus; and Merck (MERK.JK - news) and Schering-Plough Corp's Zetia and Vytorin.
An update to address some of the committee's questions from the Pediatric Advisory Committee meeting of Nov. 18, 2008, on atypical antipsychotic drugs will be provided. Abilify, Johnson & Johnson's Risperdal, Eli Lilly's Zyprexa, Pfizer (NYSE: PFE - news) 's Geodon and AstraZeneca (LSE: AZN.L - news) 's Seroquel will be included.
Two products previously planned for presentation at this meeting, Schering-Plough's Zemuron and Lantheus Medical Imaging's Cardiolite, are rescheduled for a later date.
Keywords: FDA ADVISORY/DIARY
ANTI-INFECTIVES DRUGS ADVISORY COMMITTEE
DATE: Dec 9, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Minh Doan, 301-827-7001
The committee will discuss endpoints and other clinical trial design issues in the development of antibacterial products for the treatment of community-acquired bacterial pneumonia.
ANTI-INFECTIVES DRUGS ADVISORY COMMITTEE
DATE: Dec 10, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
The committee will discuss a new drug application from Gilead Sciences Inc for inhaled aztreonam for improvement of respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa, a bacterial infection.
GASTROENTEROLOGY AND UROLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Dec 11, 0800/1300
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Megan Mickal, 301-796-5590
The committee will discuss and make recommendations on the study designs and endpoints of clinical investigations intended to support approval or clearance of devices indicated for the primary treatment of localized prostate cancer.
PEDIATRIC ONCOLOGY SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE:
DATE: Dec 15, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Diem-Kieu Ngo, 301-827-7001
The subcommittee will consider and discuss FDA expectations regarding the development of pediatric formulations for cancer drugs, and the development of dosing regimens in infants and toddlers with cancer. Keywords: FDA ADVISORY/DIARY
ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE
DATE: Dec 15, 0800/1300
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Paul Tran, 301-827-7001
The committee will discuss a supplemental new drug application from AstraZeneca for Crestor. The proposed use of Crestor in this application is primary prevention of cardiovascular disease based on the results of JUPITER. JUPITER was a clinical trial that studied individuals who did not have obvious or overt cardiovascular disease but did have the following characteristics: Low or normal levels of LDL cholesterol; elevated levels of C-reactive protein and at least one of the conventional risk factors for cardiovascular disease. In these individuals, JUPITER evaluated the reduction of risk with Crestor therapy on the study's combined objectives, which included death from heart attack or stroke, non-fatal heart attacks and strokes, unstable angina and heart or blood vessel disease that necessitates bypass surgery.
EAR, NOSE AND THROAT DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Dec 18, 0800/1300
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
CONTACT: James Kane, 301-796-6477
The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by privately held Envoy Medical Corporation, for the Esteem Totally Implantable Hearing System. The Esteem is a totally implantable hearing device that is implanted in the middle ear to help hearing in patients suffering from mild to severe hearing loss that is sensorineural in origin. The Esteem System consists of three implantable components (sound processor, sensor and driver), two external programmers (Esteem Programmer and Personal Programmer), an external Intraoperative System Analyzer and accessories. The intended use of the Esteem is to alleviate hearing loss in adults by replicating the ossicular chain and providing additional gain.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn) Keywords: FDA ADVISORY/DIARY
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