There are many benefits to participating in the Emerging Technology Program. Participants in the program can expect:
- Pre-submission face-to-face interactions with ETT members and review staff to answer technical and regulatory questions during the development and adoption of a proposed technology. Such early interactions can focus on the technology and its general applicability and do not need to be product or molecule specific.
- Regulatory and scientific input regarding what should be addressed in the Chemistry, Manufacturing, and Control (CMC) and quality sections of a regulatory submission
- Assessment of emerging technology based on quality standards and policies that consider latest scientific advancement
- Partnering with relevant FDA offices involved in pharmaceutical quality, including the Office of Compliance (OC) and Office of Regulatory Affairs (ORA), as appropriate, to review, assess, and make recommendations on the approval of a regulatory submission