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# Regeneron Urges New Guidances for Precision Medicine
- URL: https://www.fdaweb.com/regeneron-urges-new-guidances-for-precision-medicine/
- Published: 2024-06-25T12:00:00.000Z
- Updated: 2026-09-14T14:34:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157248

Regeneron says FDA should consider developing a late-stage precision medicine guidance focused on common diseases to enable the application of “-omics” in late-stage clinical development (Phase 3). Commenting on an FDA notice soliciting comments on “Promoting Effective Drug Development: Identifying Opportunities and Priorities for FDA’s Office of Clinical Pharmacology,” Regeneron says precision medicine has become the standard of care in oncology, but has not lived up to expectations for non-oncology common diseases.

The letter lists several limitations affecting precision medicine in non-oncology diseases that could be addressed in a new late-stage precision medicine guidance and suggests points to consider in such a guidance. It says FDA also should develop a guidance for complementary diagnostics for common diseases.

“We hope that our comments and proposals will contribute to the creation of guidance and forward-looking policy that focuses on discovering and validating pharmacogenomic, proteomic, and other ‘omic’ study types at the end of late-phase programs,” Regeneron says. “Further, we aim to support the agency’s objective of facilitating progress in the field of pharmacogenomics and proteomics and the use of genomic medicine as part of standard clinical care for patients.”