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US: FDA guides drug-drug interaction studies for therapeutic proteins

2020/08/11  US FDA

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.

This guidance supplements the final FDA guidances entitled In Vitro Drug Interaction Studies —Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2020).

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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