The pharmaceutical industry would like to get more clarity on the timing of drug-drug interaction (DDI) studies and the scope of these DDI studies in their comments to regulators on the proposed International Council for Harmonization’s (ICH) M12 guideline, said a regulator at an ICH regional meeting sponsored by the US Food and Drug Administration (FDA) and Health Canada on 24 February.
Rajanikanth Madabushi, associate director for guidance and scientific policy at FDA’s Office of Pharmacology, and a member of the M12 working group, provided an update on the status of the revision at the meeting.
The objective of the guideline, which was released last year for public comment, is to promote a consistent approach in designing and conducting DDI studies during the development of a new therapeutic product, said Madabushi. (RELATED: EMA consults on ICH M12 guideline for drug-drug interaction studies, Regulatory Focus 25 July 2022)…
