The US Federal Drug Administration (FDA) with the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) has provided guidance today (8/10) for drug-drug interaction studies of therapeutic proteins. The guidance specifically covers therapeutic proteins (TPs) licensed as therapeutic biological products, as well as the concepts listed in the document potentially can cover other biological products. The FDA advises sponsors to use a “systematic, risk-based” approach to decide if their TP candidates require investigational new drug application (IND) and biologic license applications (BLAs) for drug-drug interaction studies.
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