FDA Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications

https://www.gmp-navigator.com/files/guidemgr/Developing Medical Imaging Drug and Biological Products Part2.pdf

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071603.pdf