Friday, April 22, 2011

U.S. FDA advisory meetings through June 29

Tue Apr 19, 2011 2:12pm EDT

CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE

DATE: May 31, 1430/1830

LOCATION: National Institutes of Health, 29 Lincoln Drive, Building 29B, Bethesda, Md.

CONTACT: Gail Dapolito or Sheryl Clark, 301-827-0314

The committee will meet in open session to hear brief overviews of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, Center for Drug Evaluation and Research; and the Laboratory of Cell Biology, the Laboratory of Molecular and Developmental Immunology, the Laboratory of Molecular Oncology, Division of Monoclonal Antibodies, Center for Drug Evaluation and Research.

NOTE: The public is welcome to attend the meeting at NIH, where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room.

ONCOLOGIC DRUGS ADVISORY COMMITTEE

DATE: June 28-29, time TBD

LOCATION: TBD

CONTACT: TBD

The committee will review issues involved with the FDA's recommendation that Roche AG's Genentech unit's cancer drug Avastin no longer be marketed for use in breast cancer patients.

MICROBIOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: June 29, 0800/1200

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

CONTACT: Shanika Craig, 301-796-6639

The committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex.

http://www.reuters.com/article/2011/04/19/fda-advisory-diary-idUSN1929943220110419?feedType=RSS&feedName=companyNews&rpc=43

No comments:

Post a Comment