Drug-drug interaction assessment for therapeutic proteins: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Cytokines Drug Industry Drug Interactions Government Regulation United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- The purpose of this guidance is to help sponsors of investigational new drug (IND) applications and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach. For this guidance, a therapeutic protein refers to a protein that is being developed for licensure, or is licensed, as a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262). Therapeutic proteins include purified monoclonal antibodies, cytokines, enzymes, and other novel proteins for in vivo use. Therapeutic proteins do not include proteins intended to act as vaccines or allergenic products, cellular and gene therapy products, and/or human cells, tissues, and cellular and tissue-based products. Although this guidance applies to therapeutic proteins, many of the general principles may be applicable to other biological products, such as novel products regulated by CBER (e.g., cellular and gene therapies). Due to the evolving knowledge of novel products, sponsors should consult corresponding review divisions for detailed information regarding a specific DDI assessment. This guidance supplements the FDA guidances entitled In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (January 2020). In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 8 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918662584006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662584006676