Summary - Use of Positron-emitting Radiopharmaceuticals in Basic Clinical Research


The purpose of this guidance document is to provide information to sponsors who use positron-emitting radiopharmaceuticals in basic clinical research studies and to assist them in satisfying applicable federal regulatory requirements as set out in Sections C.03.301 to C.03.319 of the Food and Drug Regulations.

Who this guide is for

  • Sponsors who use positron emitting radiopharmaceuticals in basic clinical research studies
  • Persons who intend to become sponsors

In this guide

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Details and history

Published: [Month DD, YYYY]

Updated: May 18, 2015 (see all updates)

Consulted: [Month DD, YYYY] (see all consultations)

Part of topic(s): Guidance on legislation, [other relevant topic or content]

For assistance

Contact the Office of Regulatory Affairs (ORA) if you need assistance:

By phone: 613-957-1722

By e-mail:

By mail:
100 Eglantine Driveway, Tunney's Pasture
Address Locator 0601C
Tunney's Pasture,
Ottawa, Ontario
K1A 0K9

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