FDA issued a final guidance in early August regarding cGMPs for positron emission tomography (PET) drugs. The document covers resources, procedures, and documentation for PET drug-production facilities. The 1997 Food and Drug Administration Modernization Act called for these cGMPs to be established, and they are now part of 21 CFR Part 212. This guidance complements those requirements by providing information for small entities working on these drugs, such as academic and nonprofit facilities.
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