Wednesday, January 18, 2017
Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidances on medical product communications
We recognize that there is a high level of interest regarding FDA’s views on communications about medical products. We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency’s thinking on these issues. Today, the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications about medical products.