Some PET Drugs May be Exempt From NDA Requirement, Guidance Says

The FDA may allow use of an expanded access IND in place of an NDA for certain positron emission tomography (PET) drugs currently in clinical use, according to a draft guidance. Recognizing the commercial development difficulties for some products, the agency will permit some exemptions from a new regulation that required PET drug manufacturers to submit an NDA or ANDA by Dec. 12, 2011, and be operating under an approved application by Dec. 12, 2015.
Washington Drug Letter