Food and Drug Administration Activities for Patient Participation in Medical Product Discussions; Establishment of a Public Docket

摘要

The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments on FDA activities performed under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. This notice announces FDA's intent to gather input from stakeholders on strategies to obtain the views of patients during the medical product development process and ways to consider patients' perspectives during regulatory discussions. This notice provides background on ongoing patient engagement activities, so that stakeholders can consider both current and new activities that involve patient participation and perspectives during medical product regulatory discussions.