Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies (English, HTML)

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Publisher-reported update

2022-06-07

This Guidance document provides information on the interpretation and application of sections C.03.301 to C.03.320 of the Food and Drug Regulations (the Regulations) applicable to positron-emitting radiopharmaceuticals (PERs) used in basic clinical research studies.

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