> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Comments Sought on Therapeutic Protein Drug-Drug Interactions
- URL: https://www.fdaweb.com/comments-sought-on-therapeutic-protein-drug-drug-interactions/
- Published: 2018-05-09T12:00:00.000Z
- Updated: 2026-09-15T00:03:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141396

*Federal Register* notice: FDA has established a public docket to assist with its development of a policy/guidance document on assessing drug-drug interactions (DDIs) for therapeutic proteins (TPs). The agency split a 2012 DDI draft guidance into two documents published 10/2017: “In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies” and “Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications.” These two focus on enzyme- and transporter-based DDIs and do not include a discussion on TPs, which was originally included in the 2012 guidance. The agency now is revisiting the framework for assessment of DDIs for TPs and is seeking public input to assist in updating or creating a new framework. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-09931.pdf?ref=fdaweb.com).