Five Minutes in Healthcare is where I discuss current events with some of the industry's most influential leaders.

Today I am joined by Sue Bunning, managing director of Positron Emission Tomography for the MITA PET Group, for a talk about possible changes to the way stability testing is performed on PET radiopharmaceuticals in the U.S.

Currently, these agents undergo annual stability testing at a single manufacturing facility because results are considered representative of batches produced at other facilities in the approved applications. This is known as the “one stability, one facility” approach.

However, during a workshop on regulatory and compliance issues in November 2023, the FDA adopted a different position on stability testing, highlighting the need for PET manufacturers to perform stability testing at every manufacturing facility on an annual basis — despite the absence of any regulations or written guidelines specifying a change in the agency’s expectations.

Sue has a long history in radiopharmaceutical policy-making and does a nice job articulating what these proposed changes could mean for PET stakeholders. We also discuss what the next steps look like toward clarification on the issue.


We hope you enjoy the conversation.

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