REGULATORY CONSIDERATIONS IN PRECISION MEDICINE: NAVIGATING THE APPROVAL PROCESS

Abstract

Precision medicine represents a paradigm shift in healthcare, offering tailored interventions based on individual patient characteristics. Navigating the regulatory landscape for the approval of precision medicine products presents unique challenges, requiring careful consideration of factors such as biomarker qualification, companion diagnostics, real-world evidence, and regulatory pathways. This review examines the regulatory considerations involved in the approval process for precision medicine, highlighting key challenges and opportunities. By understanding and addressing these considerations, stakeholders can streamline the approval process and accelerate the translation of precision medicine innovations into clinical practice.