This post was written by Erin Janssen.

On August 4, 2011, the FDA issued final guidance for small businesses entitled “PET Drugs – Current Good Manufacturing Practice (cGMP); Small Entity Compliance Guide.” The guidance helps clarify resources, procedures, and documentation for all PET drug production facilities. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the cGMP requirements. Although this is a final guidance, FDA continues to accept comments at any time.