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Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry Draft Guidance for Industry August 2020

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

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 applications (INDs) and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein (TP) by providing a systematic, risk-based approach.

For the purpose of this guidance, a TP refers to a protein, licensed as a therapeutic biological product under section 351 of the Public Health Service Act (42 U.S.C. 262). , Although this guidance applies to therapeutic proteins, the general concepts could be applicable to other biological products, including biological products regulated by CBER such as cellular and gene therapies.

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