Early Collaboration With FDA For Novel Programs: Maximizing The Emerging Technology Program (ETP)

By Tiffany Leemkuil And Michael Fusakio, Ph.D

In 2014, the Center for Drug Evaluation and Research's Office of Pharmaceutical Quality within the U.S. Food and Drug Administration (FDA) established the Emerging Technology Program (ETP), a collaborative platform where drug developers could interface with the Emerging Technology Team (ETT). Created as a result of the technical and regulatory hurdles that novel formulations and the adoption of innovative manufacturing techniques may pose, the primary objective of the program is to address and resolve potential challenges associated with pioneering technology throughout its development and implementation journey. These interactions commence early in the development phase and continue throughout the investigational lifecycle.

The ETP also serves as a distinctive entry point for technology innovators to engage with the FDA, facilitating regular feedback integration into their development and regulatory strategies. This feature holds significant appeal for program participants. The overarching mission of ETP is to assist sponsors in advancing innovative technologies that can enhance product safety, identity, strength, quality, and purity. Effective communication and collaborative problem-solving between the FDA and developers are integral to this process.

Halloran has witnessed that ETP engagements empower developers to optimize their interactions with the FDA. Meeting enrollment criteria further provides a competitive advantage through this program. In this blog post, the authors explore the ETP, its enrollment requirements, and associated benefits, as well as delve into a recent case study demonstrating how Halloran's client has leveraged this program to their advantage.