2020 FDA Draft Guidance, "Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry"

Published on August 25, 2020
Biologics & Oligonucleotides
Drug Drug Interactions (DDI)
Regulatory Guidance
Regulatory Documents

In August 2020, the FDA released the draft guidance for industry to evaluate therapeutic proteins for drug-drug interaction (DDI) potential using a risk-based approach.

“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. ”

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2020 FDA Draft Guidance, “Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry”