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