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Home » FDA Offers Advice on Drug-Drug Interaction Assessments for Therapeutic Proteins
FDA Offers Advice on Drug-Drug Interaction Assessments for Therapeutic Proteins
Sponsors of investigational new drug (IND) applications or biologic license applications (BLAs) for a therapeutic protein should take a risk-based approach to assess the need for drug-drug interaction (DDI) studies, the FDA said in a new draft guidance.