US regulator provides final guidance for ADC developers

1 March 2024

New regulatory guidance will be of interest for the increasing number of drugmakers investing ever more R&D capital into antibody-drug conjugates (ADC).

The US Food and Drug Administration has issued the final guidance document for industry to help ADC developers to design effective research programs.

The document provides clinical pharmacology considerations and recommendations, including in relation to bioanalytical methods, dose selection and adjustment, immunogenicity and drug-drug interactions.

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