The Coalition for PET Drug Approval submitted comments to the FDA on the draft guidance entitled “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs”.
The draft guidance document is intended to assist manufacturers of PET drugs in submitting investigational new drug applications (INDs). The draft guidance summarizes the IND process for PET drugs, makes recommendations for how to submit an IND, provides advice on expanded access options for investigational PET drugs, and describes the process for requesting permission to charge for an investigational PET drug.
The Coalition comments focus on the limits to the number of patients and the amount of time that the expanded access IND may be held by the physician investigators. To view the comment letter, CLICK HERE