This guidance is intended to help producers of positron emission tomography (PET) drugs meet the requirements for FDA’s drug approval process. This guidance provides questions and answers that address nearly all aspects of the drug regulatory process, including application submission, review, compliance with current good manufacturing practices, inspections, registration and listing, and user fees.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.