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USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity

Last week (02 June 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research released two (final) guidances "Drug-Drug Interaction Assessment for Therapeutic Proteins" and "Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals".


A therapeutic protein refers to a protein that is under development for licensure, or that has been licensed, as a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262).


These proteins are typically derived from living organisms, such as humans, animals, or microorganisms, and are designed to mimic or enhance natural proteins in the body that have therapeutic effects. Therapeutic proteins include purified monoclonal antibodies, cytokines, enzymes, and other novel proteins for in vivo use.


This guidance provides recommendations for a systematic, risk-based approach to drug-drug interaction (DDI) studies for therapeutic proteins in order to assist sponsors of investigational new drug (IND) applications and biologic license applicants (BLAs) in determining whether drug-drug interactions are necessary.



This guidance aims to guide sponsors in evaluating the immunotoxic potential of pharmaceuticals in nonclinical conditions.


Immunotoxicity is defined as unintended immunosuppression or stimulation (including hypersensitivity), which can result from pharmaceuticals that are intended to modulate the immune system, as well as adverse effects from exaggerated pharmacology.


This guidance applies to drug products, including small molecule drugs and oligonucleotides, as well as certain biological products, including biotechnology-derived therapeutic proteins (referred to herein as biopharmaceuticals). The term pharmaceutical is used as a general term to encompass all of these product types; however, cell and gene therapies, adjuvanted vaccines, and blood products are excluded from the scope of this guidance.


Also, USFDA two released Drug Development guidance last week, click the respective LINKs to know more in detail

This guidance is meant to assist sponsors in the clinical development of migraine prevention drugs, and it also contains a summary of the current FDA (Food and Drug Administration) thinking on the overall development program and clinical trial designs to support the approval of migraine prevention drugs.


In this draft guidance, recommendations are provided for drug development programs aimed at treating patients suffering from interstitial cystitis/bladder pain syndrome (IC/BPS).

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