Day: March 16, 2017

This week Dr. Scott Gottlieb was nominated to head the FDA. Dr. Gottlieb has a very interesting resume. He was the Deputy Commissioner at FDA, followed by working at political think-tanks and a very active investor in FDA regulated companies, so obvious questions about conflict of interest may arise at his confirmation. The confirmation of … Read more

This week FDA announced its plans to open a new Office of Patient Affairs (OPA) to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. However, how will this office impact regulatory decisions is not clear. According to the notice in the Federal Register, this idea came about … Read more