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:
http://www.gpo.gov/fdsys/pkg/FR-2012-12-04/html/2012-29157.htm
coalitionforpetdrugs.org 