FDA Offers Guidance on Developing Biomarkers

The FDA released draft guidance for drug sponsors with some rules of the road for developing biomarkers.

When considering benefits and risks for a proposed biomarker, sponsors “should address the consequences of incorrect decision-making or harm to patients if the correlation between the biomarker and the outcome of interest does not indicated what it is intended to indicate,” the agency said.

Regulators are more likely to tolerate uncertainty if sponsors can show that the benefits of a proposed biomarker far outweigh the risks or if they can demonstrate that they’ve got an effective risk mitigation plan in place.