How to Participate in ETP

Criteria to Participate in the Emerging Technology Program

To qualify for participation in the Emerging Technology Program, technologies need to:

Have the potential to improve product safety, identity, strength, quality, and purity
Include one or more elements subject to quality assessment for which the Agency has limited review or inspection experience, including an innovative or novel:
1. Product technology (e.g., dosage form or packaging such as a container and closure system)
2. Manufacturing process (e.g., design, scale-up or lifecycle approaches)
3. Control strategy (e.g., testing technology or process controls)

Interested industry representatives and sponsors who meet the above qualifications should submit a written request to participate in the program along with a five-page proposal as outlined in Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization.

The five-page proposal must include:

A brief description of the proposed emerging technology
A brief explanation why the proposed emerging technology is substantially novel and unique and should be considered under this program
A description of how the proposed emerging technology could potentially improve product safety, identity, strength, quality, or purity
A summary of the development plan and any perceived roadblocks to implementation (e.g., technical or regulatory)
A timeline for a submission of an Investigational New Drug Application (IND), original or supplemental Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), or New Drug Application (NDA), or Drug Master File (DMF) and its associated application

Requests and proposals may be sent by email to: CDER-ETT@fda.hhs.gov

Note: This program only affects the quality section of applications to FDA (CMC and facility-related information).