FDA ready to start adding biomarker safety tests

The San Francisco Chronicle is reporting that the FDA is prepared to back a new safety standard on preclinical drugs that could--at some point--significantly reduce the time and expense of testing a new therapy. The new standard would rely on seven biomarkers that indicate kidney injury. And the FDA wants to adopt a series of such biomarker tests that could flag heart damage, liver damage and cancerous side effects.

"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, tells the Chronicle. Woosley is working with the FDA to safely speed drug development.

For now, though, the FDA says it will only accept the new biomarker test in addition to the animal safety studies the researchers already rely on. So any savings that a developer can look forward to will have to follow a period of added costs.

- read the article [1] in the San Francisco Chronicle