Description
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.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies | HTML | Open resource | |
| Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies | HTML | Open resource |