U.S. Food and Drug Administration
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Upcoming Meetings

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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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