FDA Publishes Guidance on Drug-Drug Interaction Studies for a Therapeutic Protein
The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.
FDA published guidance in August 2020 to assist sponsors of investigational new drug (IND) applications and biologic license applications for therapeutic proteins (TPs) in determining the need for drug-drug interaction (DDI) studies. The guidance focuses on therapeutic biological products as defined under section 351 of the Public Health Service Act but may also apply to other biologic products regulated by the Center for Biologics Evaluation and Research.
FDA states in the guidance that “when evaluating the potential for a DDI between a TP and small molecules or between TPs, sponsors should consider the mechanisms of a potential DDI, taking into account the pharmacology and clearance of the TP as well as any co-administered medications in the patient population.” The document gives examples of situations where a DDI of a TP may be needed and recommends “a systematic, science-driven approach to evaluate the DDI potential of TPs.”
The guidance is a supplement to 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.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
