M12 Drug Interaction Studies August 2022
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of Regulatory Policy
This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. A consistent approach will reduce uncertainty for pharmaceutical industry to meet the requirement of multiple regulatory agencies and lead to more efficient utilization of resources.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-1527.