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RISK COMMUNICATION ADVISORY COMMITTEE
DATE: February 26-27, 8:00 a.m.
LOCATION: National Transportation Safety Board (NTSB) Conference Center,
429 L'Enfant Plaza SW,
Washington, DC 20594
CONTACT: Lee L. Zwanziger, 301-827-2895. On both days there will
be a discussion of different types of prescription drug information
currently available to patients in the form of Medicating Guides,
Patient Package Inserts (PPIs), and Consumer Medication Information
(CMI). More Information
ARTHRITIS ADVISORY COMMITTEE
DATE: March 5, 8:30 a.m.
LOCATION: Hilton Washington DC/Silver Spring,
The Ballrooms,
8727 Colesville Road
Silver Spring, Maryland
CONTACT: Nicole Vesely, Pharm.D., 301-827-7001. The committee
will discuss biologics license application (BLA) 125293, pegloticase,
Savient Pharmaceuticals, Inc., as a therapy for patients with
treatment failure gout. More Information
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
DATE: March 18, 8:00 a.m.
LOCATION: Marriott Conference Centers,
UMUC Inn and Conference Center by Marriott
3501 University Blvd., East,
Adelphi, Maryland
CONTACT: Elaine Ferguson, 301-827-7001. The committee will
discuss new drug application (NDA) 22-425, dronedarone 400
milligrams oral tablets, Sanofi Aventis, for the proposed indication
in patients with a history of, or current atrial fibrillation
or atrial flutter, for the reduction of the risk of cardiovascular
hospitalization or death. More Information
PUBLIC MEETING: CYTOKINE THERAPIES: NOVEL APPROACHES FOR CLINICAL
INDICATIONS
DATE: March 26-27, 8:00 a.m.
LOCATION: NYAS Conference Center, 7 World Trade Center, 250 Greenwich
St. at Barclay St., New York City, NY
CONTACT: Raymond Donnelly,
FDA CDER, 301 827-1776, Email: Raymond.Donnelly@fda.hhs.gov;
Kristy Kilpin, NYAS, 212 298-8639, Email: kkilpin@nyas.org.
This event is a public, two-day forum that will focus on the
clinical use of cytokines and cytokines antagonists as therapeutic
agents for the treatment of human diseases, including cancer
and autoimmune disorders such as rheumatoid arthritis, multiple
sclerosis and inflammatory bowel disease. More
Information
HIGH-THROUGHPUT METHODS FOR DETECTING
FOODBORNE PATHOGENS
DATE: May 6-8, 2009
LOCATION: FDA Northeast Regional Laboratory
at York College, 158-15 Liberty Avenue, Jamaica, NY 11433
CONTACT: www.yorkfdaworkshops.org or
call 718-262-2790. This three-day workshop will feature in-depth presentations
and hands-on laboratory sessions on the detection of foodborne pathogens. Experts
from FDA, CDC, USDA, AOAC and industry will present case studies and the latest
information on a variety of analytical approaches. This workshop is sponsored
by the U.S. Food and Drug Administration, the Centers for Disease Control and
Prevention, the U.S. Department Agriculture, AOAC International, York College
of the City University of New York, and the Greater Jamaica Development Corporation. More
Information
2009 PDA/FDA ASIA-PACIFIC PHARMACEUTICAL INGREDIENT
SUPPLY CHAIN CONFERENCE
DATE: June 15-19, 2009
LOCATION: Shanghai, China
CONTACT: Wanda Neal, Vice President, Programs
and Registration Services, neal@pda.org or
+1 (301) 656-5900 ext. 111. The 2009 PDA/FDA Asia Pacific
Pharmaceutical Ingredient Supply Chain Conference is
jointly sponsored by PDA and the Shanghai Municipal FDA (SHFDA)
as a result of a memorandum of understanding signed in September
2008. Conference sessions will be led by regulatory speakers
from the US FDA and the SHFDA, and industry speakers from
the United States and China. Topics of discussion will include
the global regulatory environment and the integrity of the
Pharmaceutical Ingredient Supply Chain. More information
2009 PDA/FDA JOINT REGULATORY CONFERENCE
DATE: September 14-18, 2009
LOCATION: Renaissance Hotel, 999 9th Street
NW, Washington, D.C. 20001
CONTACT: Wanda Neal, Vice President, Programs
and Registration Services, neal@pda.org or
+1 (301) 656-5900 ext. 111. The PDA/FDA Joint Regulatory
Conference offers the unique opportunity for you to
join FDA representatives and industry experts in face-to-face
dialogues. Each year, FDA speakers provide updates on the
current state of efforts impacting the development of global
regulatory strategies; while industry professionals from
some of today’s leading pharmaceutical companies present
case studies on how they employ global strategies in their
daily processes. Hear directly from FDA experts and representatives
of global regulatory authorities, and take home best practices
for compliance. More
Information
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