U.S. FDA advisory meetings through Aug 4

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.

PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE

DATE: June 9-10, 0800/1200

LOCATION: Marriott Conference Centers, UMUC Inn and Conference Center, 3501 University Blvd. East, Adelphi, MD.

CONTACT: Diem-Kieu Ngo, 301-827-7001

On both days, the committee will discuss the following drugs and vote on whether they have been shown to be effective and acceptably safe for children and teenagers:

* AstraZeneca PLC's (AZN.L) (AZN.N) Seroquel, or quetiapine fumarate, for the acute treatment of schizophrenia in patients 13 to 17 years old, and the acute treatment of bipolar mania in those ages 10 to 17.

* Pfizer Inc's (PFE.N) Geodon, or ziprasidone hydrochloride, for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in patients 10 to 17 years old.

* Eli Lilly and Co's (LLY.N) Zyprexa, or olanzapine, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents.

GASTROENTEROLOGY AND UROLOGY DEVICES PANEL OF THE MEDICAL DEVICES

DATE: June 10, 0800/1200

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Megan Mickal, 240-276-4151

The committee will discuss and make recommendations regarding general issues related to the use of ultrafiltration devices in the treatment of extracellular body fluid overload in heart failure patients. Specifically, the committee will discuss: Identifying the most appropriate heart failure patients for such treatments, determining where these treatments fit within the spectrum of treatment options, and defining what level of clinical evidence is necessary to adequately evaluate and provide labeling for these devices.

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE