14 February 2012

FDA Guidance: IND Applications for PET Drugs

FDA's draft guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to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.  Read the guidance at www.fda.gov:  Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (PDF - 461KB)

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