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, including applications submissions, review, and compliance with good manufacturing practices, inspections, registrations/listing and user fees.

For the complete Federal Register notice, please click on the following:

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