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FDA: Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs

13.12.2012
This guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug.

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