Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "FDA Oversight of PET Drug Products--Questions and Answers." This guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.