Emerging Technology Program

FDA’s Emerging Technology Program is intended to encourage technology for use in product design and pharmaceutical manufacturing. The program is open to companies that intend to include the technology as part of a regulatory submission including: investigational new drug applications (IND), original or supplemental new drug applications (NDA), abbreviated new drug applications (ANDA) or biologic license applications (BLA), or application-associated Drug Master Files (DMF) reviewed by the Center for Drug Evaluation and Research (CDER) and where that technology meets other criteria described in the Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization, Guidance for Industry. Through the Emerging Technology Program, industry representatives can meet with Emerging Technology Team (ETT) members and other relevant FDA staff to discuss, identify and resolve potential concerns regarding the development and implementation of a novel technology prior to filing a regulatory submission. 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. Emerging Technology Program: www.fda.gov/ab...