Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Drug-Drug Interaction Assessment for Therapeutic Proteins." With the continued market growth and increased clinical use of therapeutic proteins, it is important to understand the nature of and the potential for drug-drug interactions (DDIs) with these products. The purpose of this guidance is to help sponsors of investigational new drug applications (INDs) and applicants of biologics license applications (BLAs) determine the need for DDI studies for a therapeutic protein by providing a systematic, risk-based approach. This guidance finalizes the draft guidance of the same title issued on August 10, 2020.