CBER's All-Day Voyage into Slippery Science Ends in 18-6 Vote against Bladder Therapy

One might surmise that by the time FDA asks an advisory committee to vet an application, the questions would deal primarily with clinical utility.

By that stage in the game, advisors would be asked to discuss the outcomes, as opposed to the biological mechanisms for achieving them.

This was even before the agency’s reorganization of its oncology units more than a decade ago. In those days, small-molecule compounds went to one bureaucratic unit of the FDA Center for Drugs Evaluation and Research—while biologics, including monoclonal antibodies and growth factors, went to the Center for Biologics Evaluation and Research.

Capitol Hill

FDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health

Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.

The case studies included LDTs such as the Target Now cancer biomarker test, developed by Caris Life Sciences Inc.; the Oncotype DX HER2 RT-PCR breast cancer test; and the Duke University Chemotherapy Assessment genetic tumor assay.

NCI Announces Winners of Outstanding Investigator Awards

NCI named the inaugural 43 recipients of its Outstanding Investigator Awards.

Developed last year, the grant program provides funding to investigators with outstanding records of productivity in cancer research to support projects of unusual potential in cancer research.

The award provides funding of up to $600,000 in direct costs each year for seven years. One goal of the award is to provide investigators with substantial time to break new ground or extend previous discoveries to advance biomedical, behavioral or clinical cancer research.