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JOINT MEETING OF THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY
COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY
COMMITTEE
DATE: January 30, 8:00 a.m.
LOCATION: Hilton, Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Parkway,
Gaithersburg, MD
CONTACT: Kalyani Bhatt, Center for Drug Evaluation
and Research, Phone: 301-827-7001. The committee will discuss
the available safety and efficacy data for all propoxyphene-containing
products (including hydrochloric acid (HCl), napsylate salts,
and combination drugs) and whether any regulatory action is
appropriate. More
Information
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
DATE: February 3, 8:00 a.m.
LOCATION: Hilton, Washington DC/Silver Spring,
Ballroom,
8727 Colesville Road,
Silver Spring, Maryland
CONTACT: Elaine Ferguson,
Center for Drug Evaluation and Research,
Phone: 301-827-7001. The committee will discuss new drug application
(NDA) 22-307, prasugrel hydrochloride film coated oral tablets,
5 milligrams (mg) and 10 mg, Eli Lilly and Company, for the
proposed indication for use in acute coronary syndrome. More
Information
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
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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