Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies

Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research Studies 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. 2022-06-07 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentapplications for authorizationauthorization-of-positron-emitting radiopharmaceuticalsbasic clinical research-studies Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research StudiesHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/guidance-document-guide-preparation-applications-authorization-radiopharmaceuticals.html#a1 Guidance Document - Guide for the Preparation of Applications for Authorization of Positron-emitting Radiopharmaceuticals for Use in Basic Clinical Research StudiesHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/guidance-document-guide-preparation-applications-authorization-radiopharmaceuticals.html#a1

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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