Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "FDA Oversight of PET Drug Products--Questions and Answers." The draft guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review,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.