Posted by Michael Wonder on 18 Jan 2017
Statement from FDA Commissioner announcing new draft guidances on medical product communications
18 January 2017 - We recognise 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.
The first draft guidance, “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities,” explains the FDA’s current thinking and recommendations on firms’ communication of health care economic information (HCEI) about approved drugs under section 502(a) of the FD&C Act, which was recently amended by the 21st Century Cures Act. It also answers common questions and provides the FDA’s recommendations regarding firms’ communications to payors about investigational drugs and devices that are not yet approved or cleared for any use.
