Drug-Drug Interaction Assessment for Therapeutic Proteins

On 12 August 2020 the FDA announced the availability of the draft guidance for industry.

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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