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Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry Guidance for Industry June 2023

Final Level 1 Guidance
Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

The purpose of this guidance is to help sponsors of investigational new drug (IND) applications and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach.

For this guidance, a therapeutic protein refers to a protein that is being developed for licensure, or is licensed, as a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262). Therapeutic proteins include purified monoclonal antibodies, cytokines, enzymes, and other novel proteins for in vivo use. Therapeutic proteins do not include proteins intended to act as vaccines or allergenic products, cellular and gene therapy products, and/or human cells, tissues, and cellular and tissue-based products.5 Although this guidance applies to therapeutic proteins, many of the general principles may be applicable to other biological products, such as novel products regulated by CBER (e.g., cellular and gene therapies).

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1480.

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