Every technology begins with an idea – how to make something better or create something brand new. The Emerging Technology Program - or ETP - at FDA helps industry earn regulatory approval for drug applications with innovative technologies and use them to make high-quality, safe, and effective medicines.
Companies request participation in the ETP by proposing manufacturing technologies that are novel or designed to meet specific needs that benefit patients.
Since its beginning in 2014, the program has led to the approval of regulatory applications using innovative manufacturing methods for drugs and biologics, including advanced analytical tools and modeling approaches, new dosage forms, and drug delivery systems.
Early engagement is the hallmark of our program. Once selected, companies begin work with the Emerging Technology Team—or ETT—a cross functional group with members representing all the relevant offices that are responsible for quality assessment and inspection within CDER and the Office of Regulatory Affairs. Other subject matter experts within FDA may be added when needed.
Through meetings and site visits, we work together to identify and resolve roadblocks to technology implementation and regulatory approval of associated drug applications.
As milestones are met in the technology’s development, companies continually engage with the ETT to get feedback and comments as they relate to product quality and manufacturing.
Graduation of the technology is the ultimate goal of the program, which occurs when the ETT has determined that FDA and industry have sufficient experience with the technology. Future applications that include this technology then follow the standard quality assessment process.
Response to the program has been overwhelmingly positive, and FDA is working to streamline processes and enhance communication as it grows.
We invite you to visit the FDA website to learn more about the Emerging Technology Program and the application process. We look forward to working with you.
For more details about the Emerging Technology Program, visit the FDA website.
