The U.S. Federal Drug Administration (FDA) is offering the opportunity to stakeholders to submit to the FDA a proposed draft guidance on patient experience data, and has published new draft guidance (December 2018) to guide them. According to FDA Commissioner Scott Gottlieb, “Today’s guidance document is part of our commitment to advance patient focused drug development and is one of several guidances that we’re developing regarding the collection of patient experience data…” (Regulatory Focus)