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# Deficiencies in CM and RTRT-D NDA Submissions
- URL: https://www.fdaweb.com/deficiencies-in-cm-and-rtrt-d-nda-submissions/
- Published: 2023-08-16T12:00:00.000Z
- Updated: 2026-09-14T18:50:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155114

CDER researchers have identified several common deficiencies found in regulatory submissions involving the use of continuous manufacturing (CM) and/or real-time release testing for dissolution (RTRT-D). Writing in the *Journal of Pharmaceutical Sciences*, the researchers [say](https://doi.org/10.1016/j.xphs.2023.08.004?ref=fdaweb.com) their intent is to provide recommendations for best practices that will help advance the field by:

- generating greater opportunities for drug applicants to benefit from the implementation of advanced manufacturing approaches;
- improving high-quality regulatory submissions involving CM and RTRT-D and thus
- lessening the regulatory review burden.

“A starting point for developing a robust and credible RTRT-D is an optimal dissolution method whose behavior is plausible and discriminating with respect to as many critical material attributes and critical process parameters as possible,” the researchers write. “In this context, developing a clinically relevant dissolution method would be ideal.”