> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CDER Program Helping Companies Innovate: Post
- URL: https://www.fdaweb.com/cder-program-helping-companies-innovate-post/
- Published: 2020-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:57:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145797

A *Genetic Engineering and Biotechnology* online post says that the CDER Emerging Technology Program is helping biotechnology and pharmaceutical companies innovate and still negotiate any regulatory steps as easily as possible. CDER Emerging Technology Team (ETT) director **Sau Lee** is quoted in the [post](https://www.genengnews.com/topics/bioprocessing/engaging-the-fda-on-innovation-in-biomanufacturing/?ref=fdaweb.com) as saying that the program employs a combination of early engagement, face-to-face meetings, FDA site visits, integrated quality assessments, and pre-approval inspections. “The same ETT representatives that engage with the company will likely be involved in the entire process,” he said.

Companies that are accepted in the program can get early agency feedback about their emerging technology even before a drug or product candidate has been associated with the technology, Lee said.

Technologies that companies have inquired about, Lee said, include controlled ice nucleation for lyophilization processes; comprehensive product testing using a single multi-attribute assay; continuous manufacturing for a downstream process; end-to-end integrated bioprocess; and small manufacturing platforms for continuous bioprocesses, such as pharmacy on demand.

“A company gets a forum for early dialog with FDA to support innovation; identification of potential roadblocks relating to existing guidance, standards, policy, or practice; and consistency and continuity in assessment and inspection,” Lee said.