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PREPARATION FOR INTERNATIONAL CONFERENCE ON HARMONIZATION MEETINGS IN BRUSSELS, BELGIUM
DATE: October 21, 3:00 p.m.
LOCATION: 5600 Fishers Lane, 3rd Floor, Conference Rooms D and E, Rockville, MD.
CONTACT: Tammie Jo Bell, Office of the Commissioner, 301-827-0003. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Brussels, Belgium, November 10 to 13, at which discussion of the topics underway and the future of ICH will continue. More Information
ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE
DATE: October 21, 8:00 a.m.
LOCATION: Crowne Plaza Hotel,
Washington DC-Silver Spring,
8777 Georgia Ave.,
Silver Spring, MD,
(301) 589-0800
CONTACT: Paul Tran, R.Ph., 301-827-7001. On October 21, 2008, the committee will begin with a closed session from 8 a.m. to 11 a.m. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. The committee will discuss the safety and efficacy of biologic license application (BLA) 125291, MYOZYME (algucosidase alfa) Genzyme Corporation, for the treatment of late onset Pompe disease. More Information
PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE
DATE: October 23, 8:00 a.m.
LOCATION: Hilton Washington DC, Silver Spring,
The Ballrooms,
8727 Colesville Road,
Silver Spring, MD
CONTACT: Diem-Kieu Ngo, 301–827–7001.
The Committee will discuss the clinical development of radionuclide
imaging products for the detection of amyloid to assist in the
diagnosis of Alzheimer's Disease. More
Information
JOINT MEETING OF THE ANTIVIRAL DRUGS ADVISORY COMMITTEE AND THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE
DATE: October 29, 8:00 a.m.
LOCATION: Hilton The Ballrooms, 1750 Rockville Pike, Rockville, MD.
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827-6793. The committee will provide advice on types of studies and trial designs needed for an influenza antiviral MedKit for the treatment or prophylaxis of pandemic influenza and discuss publicly the proposed development program that would support an application for such a MedKit. Issues such as the role of personal MedKits, home stockpiling, non-prescription availability of influenza medications, and interfaces of home readiness with public health systems, will be raised in the course of the discussions. More Information
ANTIVIRAL DRUGS ADVISORY COMMITTEE
DATE AND TIME: October 30, 9:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring, The Ballrooms, 1750 Rockville Pike, Rockville, MD
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827-6793. The meeting will be open to the public from 8 a.m. to 9 a.m., unless public participation does not last that long. From 9 a.m. to 1 p.m., the meeting will be closed to permit discussion of current and future advances on antiviral drugs which will include the review of trade secret and/or confidential information. More Information
SCIENCE WRITERS SYMPOSIUM
DATE: November 10, 8:15 a.m.
LOCATION: FDA White Oak campus, 10903 New Hampshire Ave, Silver Spring, Maryland
CONTACT: sciencewriters@fda.hhs.gov; Registration:
301-827-9775. Science is the foundation for the FDA’s daily decisions on a wide range of products that affect human and animal health—from the most common food ingredients, to complex medical and surgical devices, to lifesaving drugs. The upcoming Science Writers Symposium and lab tour on November 10, 2008, will highlight how the FDA employs novel scientific approaches to critical medical issues. The event will offer science writers a useful starting point for exploring the wealth of scientific topics at the FDA.
More Information
STRUCTURED PRODUCT LABELING CONTENT OF LABELING AND ELECTRONIC DRUG ESTABLISHMENT REGISTRATION AND DRUG LISTING FOR THE BIOLOGICS INDUSTRY
DATE: November 17, 8:30 a.m.
LOCATION: Universities at Shady Grove, Multipurposes Room, Building II, 9630 Gudelsky Dr., Rockville, MD.
CONTACT: Donna Lipscomb, Center for Biologics Evaluation and Research, 301-827-2000. The purpose of the public workshop is to provide the biologics industry with guidance on submitting to FDA content of labeling in SPL format, present an overview of FDA’s voluntary pilot program for electronic submission of drug establishment registration and drug listing information under the regulations, and exhibit vendor SPL authoring tools that may be used in the creation and manipulation of SPL content of labeling. More Information
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