மருந்து ஒழுங்குமுறை விவகாரங்கள்: திறந்த அணுகல்

Regulatory Challenges of Brain Delivered Therapies: A Combination Product Perspective

Abstract

Catherine Gauthier-Campbell* and Thomas Lester and Victoria Sluzky

Delivery of therapeutic agents directly to the central nervous system can be critical to address a number of diseases. Intraventricular administration of drugs has been used for over 50 years. Despite a substantial number of drugs routinely administered to the central nervous system in the course of medical practice, very few medical devices are appropriately cleared in the US for this route of administration. This review explores the regulatory challenges, the supplementary testing and more stringent acceptance criteria required for combination products and medical devices intended for CNS therapies. A case study of the recent Brineura^® combination product approval is also presented.