PET drugmakers have 3 years to secure approvals

12/4/2012 | AuntMinnie.com (free registration)

The FDA has released guidelines for PET drug manufacturers, establishing a December 2015 deadline for approvals through new drug applications, abbreviated new drug applications or investigational new drug applications for PET drugs being used in the clinical setting. The guidelines include recommendations on the steps companies should take in submitting applications and the required safety data.

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