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Developing Medical Imaging Drug and Biological Products, Part 1: Conducting Safety Assessments - PharmaFacts
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Developing Medical Imaging Drug and Biological Products, Part 1: Conducting Safety Assessments

Guidances - FDA Guidances

UCM078930.pdfalt
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078930.pdf