Regulatory Perspective on Biomarkers and Surrogate Endpoints

As the Director of the Evaluation of Radiopharmaceuticals and Biotherapeutic Products at Health Canada, Dr. Klein gives a brief background on the introduction of the Food and Drug Act in Canada, followed by a full explanation of the regulatory process for biomarkers in Canada. The regulatory body focuses on the quality, safety and efficacy of diagnostic, preventative and therapeutic agents, being constantly evaluated from first discovery through market use to further evolution and all steps between.