FDA’s Center for Tobacco Products published the actions it plans to take in response to an external evaluation commissioned last year from an independent panel of evaluators working through the Reagan-Udall Foundation.
As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments. Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were...
