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# CDER Outlines Internal Research on 3D-printed Drug Products
- URL: https://www.fdaweb.com/cder-outlines-internal-research-on-3d-printed-drug-products/
- Published: 2017-12-11T12:00:00.000Z
- Updated: 2026-09-14T23:06:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140316

CDER’s Office of Testing and Research is conducting research to better understand 3D or additive manufacturing’s use in making drug products. “3D printing can offer a tantalizing step toward changing the manufacturing processes to offer personalized medicines,” a new [blog post](http://webmail.fdaweb.com/a/webmail.php?wsid=00b7391049126f53a8a6a8571115d175448c9440&ref=fdaweb.com) says. “For example, we are working to understand the effects of material attributes, 3D geometric designs and 3D printing process parameters on the performance of 3D-printed solid dosage forms. In addition, we are trying to develop mechanistic models for 3D printing processes that can predict a drug’s performance in different patients.”

The research, the Center says, will give the agency answers to key regulatory questions, such as what are the critical parameters affecting the printability of various materials into drug products? What are the critical process parameters for each 3D printing technology? How to assess the performance of 3D printed drug products? Can traditional *in vitro* testing methods for 3D printed drug products be used?

CDER’s 3D printing facility is also studying excipient behavior of the conventional dosage forms during the 3D-printing processes, and discovering ways to manage or control their behavior, the post says. The functions of commonly used inactive ingredients may not be applicable for 3D printing processes, it explains. “We are looking to better understand these differences, and developing a ‘risk map’ that can describe how the variations in material attributes and how they are processed may impact the quality, safety and efficacy of a drug product. We are analyzing these potential risks and determining the best way to mitigate them.”

CDER is also evaluating regulatory challenges associated with 3D-printed drug products, and to what extent the 3D-printing process may be controlled to ensure the quality of 3D-printed drug products. CDER says it is working with CDRH staff on the best ways to approach these and other questions.