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Posted 27 February 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) released new draft guidance 27 February on Positron Emission Tomography (PET) drug products.
FDA notes that Guidance: FDA Oversight of PET Drug Products Questions and Answers "provides  questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees."
Comments on the draft guidance are due by 29 May 2012.
Guidance: FDA Oversight of PET Drug Products Questions and Answers
Federal Register - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability
Tags: Answers, Questions, Positron Emission Tomography, PET, Pharmaceuticals, Q&A, Latest News, draft guidance, guidance, drug
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