Monday October 26, 08:06 PM
U.S. FDA advisory meetings through Dec. 15
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES ON OR BEFORE OCT. 31 ARE EDT/GMT, ALL TIMES ON OR AFTER NOV. 1 ARE EST/GMT.
For more information on the FDA's Advisory Committee meetings, see: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Adds Dec 9-10 anti-infectives meeting, Dec 15 endocrinologic and oncology meetings)
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: Oct 27, 0800/1200
LOCATION: Hilton, 8727 Colesville Rd., Silver Spring, Md.
CONTACT: Minh Doan, 301-827-7001
The committee will discuss Human Genome Sciences Inc's raxibacumab injection, known as ABthrax, to treat anthrax infection.
ANESTHESIOLOGY AND RESPIRATORY THERAPY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Oct 28, 0800/1200
LOCATION: Hilton, 620 Perry Pkwy., Gaithersburg, Md.
CONTACT: Neel Patel, 301-796-5580
The committee will discuss, make recommendations, and vote on a Asthmatx Inc's Alair Bronchial Thermoplasty System for the treatment of severe persistent asthma in adults.
**POSTPONED*
NATIONAL MAMMOGRAPHY QUALITY ASSURANCE ADVISORY COMMITTEE
DATE: Nov 2, 0900/1400
LOCATION: Holiday Inn, Two Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Normica Facey, 301-796-5914
The committee will discuss guidance documents issued since the last meeting. It will also receive updates on: Interventional mammography accreditation programs, recently approved alternative standards, facility inspection findings, the status of current inspection followup actions, and the radiological health program.
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.
Keywords: FDA ADVISORY/DIARY
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. Keywords: FDA ADVISORY/DIARY
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.
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.
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).
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; Schering-Plough Corp's Zemuron; Merck & Co's Cancidas; Lantheus Medical Imaging's Cardiolite; 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's Zetia and Vytorin.
The committee also will receive a brief update on atypical antipsychotic drugs as requested by the Pediatric Advisory Committee meeting on November (Frankfurt: A0Z24E - news) 18, 2008. 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.
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.
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 (LSE: AZN.L - news) 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.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn) Keywords: FDA ADVISORY/DIARY
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