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# CDER Emerging Technology Program Expanding
- URL: https://www.fdaweb.com/cder-emerging-technology-program-expanding/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150354

CDER director **Patrizia Cavazzoni** and Office of Pharmaceutical Quality director **Michael Kopcha** say the Center’s efforts to promote advanced manufacturing initiatives through its Emerging Technology Program (ETP) have increased to the point that ETP 2.0 is being created to meet workload challenges and enhance communication with companies that would like to adopt advanced manufacturing technologies in the future. Writing in an online *FDA Voices* [post](https://www.fda.gov/news-events/fda-voices/fdas-advanced-manufacturing-initiatives-helping-provide-quality-human-drugs-patients?utm%5Fmedium=email&utm%5Fsource=govdelivery), the two say that under the enhanced ETP, more agency staff will be trained on new technologies to improve FDA’s ability to evaluate them.

The post cites a National Academies of Sciences, Engineering, and Medicine consensus report identifying technologies FDA can expect to see in future regulatory submissions. “We are now addressing any knowledge and experience gaps to form the regulatory framework required for these technologies,” FDA says. The identified technologies are: 

- end-to-end continuous manufacturing, a process that integrates active pharmaceutical ingredient and drug product manufacturing in one process;
- portable and modular distributed manufacturing platforms, also known as pharmacy-on-demand; and
- artificial intelligence and advanced modeling approaches in manufacturing.

Cavazzoni and Kopcha write that to maintain the momentum of advanced manufacturing in the human drug and biologics programs, FDA formally established an internal Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals 6/2021 “to enhance coordination and collaboration of science, regulatory, and policy activities.”