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Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry Draft Guidance for Industry August 2020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Not for implementation.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.

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.

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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