Monthly Archives: December 2012

FDA announces Q&A guidance on Oversight of PET Drug Products

On Tuesday, December 4, 2012, the Food and Drug Administration announced the availability of a guidance entitled, “FDA Oversight of PET Drug Products- Questions and Answers.” The Q &A’s cover almost all areas of the FDA approval and surveillance processes, … Continue reading

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FDA announces availability of IND applications for PET Drugs

On Tuesday, December 4, 2012, the Food and Drug Administration announced the availability of a guidance entitled, “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.” This guidance will support manufacturers of PET drugs in submitting investigational new drug … Continue reading

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