[Regulatory Practices and Implications of FDA Approving New Drug Indication under the Medical Device Pathway].

Zusammenfassung

Under the U.S. medical product regulatory framework, innovative medical devices used in conjunction with approved drugs for new usage will often raise regulatory issues. To address these regulatory challenges and foster industry innovation, the FDA has proposed a new regulatory pathway. This paper traces the regulatory journey and risk analysis of the FDA in approving new uses of optical imaging agents and contrast agents through the medical device regulatory pathway. On this basis, it discusses