The Center for Drug Evaluation (CDE) has released the “New Drug Benefit-Risk Assessment Technical Guidelines,” which are open for public feedback for a one-month period. These guidelines are designed to determine whether a drug’s expected benefit outweighs the potential risks for the proposed indication.
Draft Proposal Background
The draft proposal is based on several key documents, including the US FDA’s “Benefit-Risk Assessment for New Drug and Biological Products,” the revision of the “M4e Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH,” and the “ICH E2C(R2) Periodic Benefit-Risk Evaluation Report.” These references provide a comprehensive framework for the assessment process.
Guidelines Overview
The document clarifies the regulatory background and overall considerations for benefit-risk assessment. It outlines how to present the benefit and risk information of drugs in marketing applications, the framework and important considerations for benefit-risk assessment, and how applicants can provide information for benefit-risk assessment through the design and implementation of drug research and development. These guidelines are applicable to the benefit-risk assessment of clinical research and development and marketing applications for both chemical drugs and biological products.-Fineline Info & Tech
