FDA Update: Week Of June 28, 2010

By Lori Clapper, Web Editor

New Hepatitis C Test
The FDA has approved a blood test to detect the hepatitis C virus. The OraQuick HCV Rapid Antibody Test is a test strip and does not require an instrument for diagnosis. The test detects the virus in only 20 minutes.

"Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Getting faster treatment is an important public health step to control this dangerous disease."

The U.S. Centers for Disease Control and Prevention reports approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

Flu Season — Already?
Even though flu season is still months away for most of us, the FDA is already thinking about it. You can view the FDA recommendations for U.S. influenza vaccines for the 2010-2011 season here.

Safety Reporting
Last month, the FDA and the NIH launched an online tool for reporting premarket and postmarket safety data to the U.S. government. Currently, you can report problems with veterinary drugs and other animal products, as well as human gene transfer trials.

In the future, the system will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies. The goal is a common electronic reporting system that will allow an individual to file a single report to multiple agencies that may have an interest in the event.