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# FDA Moving Toward Emerging Technology Regs: Kopcha
- URL: https://www.fdaweb.com/fda-moving-toward-emerging-technology-regs-kopcha/
- Published: 2022-05-19T12:00:00.000Z
- Updated: 2026-09-14T17:45:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151848

CDER Office of Pharmaceutical Quality (OPQ) director **Michael Kopcha** says the agency is moving toward drafting and implementing regulations on pharmaceutical advanced manufacturing technology. Speaking during a PharmTech *Drug Solutions* [podcast](https://www.pharmtech.com/view/drug-solutions-podcast-fda-weighs-in-on-advancing-the-science-of-pharmaceutical-manufacturing?ref=fdaweb.com), Kopcha said manufacturing advances have been slow to occur in the pharmaceutical industry due to company concerns about regulations.

He said OPQ has been a venue for companies to talk with agency staff about new technologies they would like to apply for products coming to market.

OPQ also has developed the Framework for Advanced Manufacturing Evaluation (FRAME) to move the effort forward and has worked with the National Academy of Sciences to identify possible advanced technologies. With continuing stakeholder input, this will lead to regulations, Kopcha said.

Also appearing on the podcast were OPQ deputy director for science **Sau Lee** and deputy director for operations **Cindy Buhse**.

Other topics the three discussed were quality management maturity ratings; quality of pharmaceuticals and its relatability to other variables, such as economics; continuous vs. batch manufacturing; pandemic pressures and improved communication; keeping up with biotech and emerging therapies; and what manufacturers need to know.