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# Draft Guide on Drug Interaction Assessments
- URL: https://www.fdaweb.com/draft-guide-on-drug-interaction-assessments/
- Published: 2020-08-07T12:00:00.000Z
- Updated: 2026-09-14T16:24:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147384

FDA has made available a [draft guidance](https://www.fda.gov/media/140909/download?ref=fdaweb.com) entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to help sponsors determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing a systematic, risk-based approach.

When evaluating the potential for a DDI, FDA says “sponsors should consider the mechanisms of a potential DDI, taking into account the pharmacology and clearance of the therapeutic protein as well as any co-administered medications in the patient population.” The guidance also provides examples of the types of situations in which an assessment of the DDI potential of a therapeutic protein can be warranted.