The US Food and Drug Administration (FDA) on Friday issued a final guidance to assist sponsors in determining whether to conduct drug-drug interaction studies for therapeutic proteins for investigational new drug applications (INDs) and biologics license applications (BLAs).
The guidance, which was jointly issued by the Center for Drug Evaluation and Resarch (CDER) and the Center for Biologics Evaluation and Research (CBER), contains minor revisions from an earlier draft issued in August 2020. (RELATED: FDA guides drug-drug interaction studies for therapeutic proteins, Regulatory Focus 10 August 2020).
The agency announced that “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.”…
