U.S. FDA advisory meetings through Aug 13

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

For more information on the FDA's Advisory Committee meetings, see: here

ONCOLOGIC DRUGS ADVISORY COMMITTEE

DATE: July 15, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Nicole Vesely, 301-827-6793

The committee will discuss a new drug application from Johnson & Johnson (JNJ.N) for trabectedin intravenous infusion in combination with Doxil for the treatment of patients with relapsed ovarian cancer. The proposed trade name for trabectedin is Yondelis.

The committee also will discuss a supplemental new drug application from Johnson & Johnson for intravenous infusion of Doxil in combination with docetaxel for the treatment of patients with locally advanced or metastatic breast cancer who have received prior anthracycline treatment.

HEMATOLOGY AND PATHOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: July 17, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Louise Magruder, 240-276-1248

The committee will discuss and make recommendations on a Clinical Laboratory Improvement Amendment Waiver application for the HemoCue WBC Analyzer, sponsored by HemoCue Inc, a unit of Quest Diagnostics (DGX.N). The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) counts in capillary or venous whole blood and can be used in clinical laboratories and at point-of-care settings.

BLOOD PRODUCTS ADVISORY COMMITTEE

DATE: July 20, 0800/1200 and July 21, 0900/1300