PET Drugmakers May Need ANDAs in 2015

January 21, 2013
All positron emission tomography (PET) producers must have an approved NDA, ANDA or effective IND application by Dec. 12, 2015, according to an FDA guidance. The document finalizes draft guidance issued earlier in 2012, in which the FDA said it would take action against PET producers that had not submitted an NDA by Dec. 12, 2011.
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