Pre-approval Information Exchange White Paper

Pre-approval Information Exchange (PIE)

The goal of the PIE Act is to facilitate the exchange of product-related information between manufacturers and health care decision makers (HCDMs) prior to U.S. Food and Drug Administration (FDA) approval to advance patient access to new medical products. While closely aligned with FDA guidance on communications between manufacturers and HCDMs, there are some differences.

This paper outlines where the two align, including communications for appropriate audiences, information on proactive information sharing and suggested timelines for communication and where they differ, such as the types of information that can be shared and additional information each document provides.