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ALLERGENIC PRODUCTS ADVISORY COMMITTEE
DATE: March 18, 8:00 a.m.
LOCATION: Food and Drug Administration, Center for Drug Evaluation and Research, Advisory Committee Conference Room, Room 1066, 5630 Fishers Lane, Rockville, MD
CONTACT: Gail Dapolito,
301-827-0314. On March 18, 2009, the committee will discuss 1) a proposed change of potency assay for short ragweed pollen and cat allergen extracts from radial immunodiffusion assay to an enzyme-linked immunosorbent assay and 2) structured product labeling. The committee will also receive an update on research programs in the Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. More Information
CIRCULATORY SYSTEM DEVICES PANEL
DATE: March 18, 8:00 a.m.
LOCATION: Hilton Washington DC North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy.,
Gaithersburg , MD
CONTACT: James Swink, 240-276-4050. The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by TherOx, Inc., for the TherOx Aqueous Oxygen System (AO System). The system is intended for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization less than or equal to 6 hours from symptom onset. These patients are then randomized to AO Therapy or not. The endpoint is reduction in the final size of the infarct. The system draws blood from the patient, hyperoxygenates it with the AO cartridge component of the system, and reinfuses the blood via the infusion catheter directly to the infarction site of the heart. This therapy is intended to be performed for 90 minutes post percutaneous coronary intervention/stenting. 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
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
DATE: March 19, 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) 22-406, rivaroxaban oral tablets (10 milligrams) Johnson & Johnson Pharmaceutical Research & Development, L.L.C., for the proposed indication for use in prophylaxis of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery or knee replacement surgery. 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
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
DATE: April 7-8, 8:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring,
The Ballrooms,
8727 Colesville Road,
Silver Spring, Maryland
CONTACT: Yvette Waples,
Center for Drug Evaluation and Research, 301-827-7001. On April 7, 2009, the committee will discuss safety and efficacy issues with new drug application (NDA) 20-644, Serdolect (sertindole) tablets, Lundbeck USA, proposed for the treatment of schizophrenia. On April 8, 2009, the committee will discuss safety and efficacy issues of supplemental new drug applications (sNDAs) 22-047/S-010/S-011/S-012, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of major depressive disorder and sNDA 22-047/S-014/S-015, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of generalized anxiety disorder. Particular safety issues for discussion on April 8, 2009, regarding the Seroquel XR applications are concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia. More Information
FDA SMALL PHARMACEUTICAL BUSINESS ASSISTANCE EDUCATIONAL FORUM PUBLIC WORKSHOP
DATE: April 23, 8:00 a.m.
LOCATION: Food and Drug Administration, Atrium Conference Room, 158-15 Liberty Ave. Jamaica, NY 11433
CONTACT: Ms. Odinga Charles (718) 662-5622 or the Small Business Representative, Marilyn Rodriguez-Bohorquez (718) 662-5618. The workshop is to provide information to small pharmaceutical businesses about FDA's premarket requirements; good manufacturing practices; OTC and generic drug issues. More Information
RISK COMMUNICATION ADVISORY COMMITTEE
DATE: April 30-May 1, 8:00 a.m.
LOCATION: Food and Drug Administration,
Center for Drug Evaluation and Research Advisory Committee Conference Room,
Rm. 1066,
5630 Fishers Lane, Rockville, MD.
CONTACT: Lee Zwanziger,
Office of Commissioner,
Office of Policy Planning and Preparedness,
Office of Planning, (301) 827-2895. On both days the Committee will discuss the Agency's draft risk communication strategic plan and will be asked for comment and further advice, for example, on strategic priorities for research on effective risk communication. 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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