DATE: May 12, 0800/1200
LOCATION: Doubletree Hotel, 8120 Wisconsin Ave., Bethesda, Md.
CONTACT: Gail Dapolito or Jane Brown, 301-827-0314
The committee will receive updates and discuss the following topics:
(1) Structure and Activities of the Laboratory of Immunobiochemistry in the Division of Bacterial, Parasitic, and Allergenic Products at the FDA’s Center for Biologics Evaluation and Research
(2) enzyme-linked immunosorbent assay replacement of radial immunodiffusion assays for potency determinations of cat and ragweed pollen allergen extracts by Laboratory of Immunobiochemistry
(3) statistical considerations for the design and interpretation of phase III clinical trials of allergenic products
(4) environmental exposure chambers for phase III studies of allergenic products and
(5) International Organization for Standardization (ISO) 17025 accreditation of the Laboratory of Immunobiochemistry.
NONPRESCRIPTION DRUGS ADVISORY COMMITTEE AND THE PEDIATRIC ADVISORY COMMITTEE
DATE: May 17-18, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Diem-Kieu Ngo, 301-796-9001
The committees will review pertinent pharmacokinetic, safety and efficacy data, and discuss whether new dosing information for oral over-the-counter drug products containing acetaminophen should be added to the label for children less than 2 years of age. In addition, the committees will consider adding a weight-based dosing regimen to the existing age-based dosing regimen for children 2 to 12 years of age. Dosing for children 12 years of age and older will not be discussed. Lastly, the committees will discuss ways that administration by caregivers can be improved so that medication errors can be minimized.
DATE: June 28-29, time TBD
The committee will review issues involved with the FDA’s recommendation that Roche Holding AG ROG.VX Genentech unit’s cancer drug Avastin no longer be marketed for use in breast cancer patients.
MICROBIOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: June 29, 0800/1200
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Shanika Craig, 301-796-6639
The committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)