Nonclinical evaluation of the immunotoxic potential of pharmaceuticals: guidance for industry

Nonclinical evaluation of the immunotoxic potential of pharmaceuticals: guidance for industry

Collection:
Health Policy and Services Research
Contributor(s):
Center for Drug 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):
Drug Evaluation, Preclinical
Drug Industry
Government Regulation
Pharmaceutical Preparations
Toxicity Tests
United States
Genre(s):
Guideline
Technical Report
Abstract:
The purpose of this guidance is to assist sponsors in the nonclinical evaluation of the immunotoxic potential of pharmaceuticals. Immunotoxicity is, for the purposes of this guidance, defined as unintended immunosuppression or stimulation (including hypersensitivity), which can include adverse effects of exaggerated pharmacology of pharmaceuticals that are intended to act as immunomodulators. This guidance applies to drug products, including small molecule drugs and oligonucleotides, as well as certain biological products such as biotechnology-derived therapeutic proteins (referred to herein as biopharmaceuticals). For the purposes of this guidance, the term pharmaceutical will be used as a general term that encompasses all of these product types. Cell and gene therapies, adjuvanted vaccines, and blood products are not within the scope of this guidance. 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 guidances 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 (11 pages))
NLM Unique ID:
9918662583506676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918662583506676