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PET imaging agent manufacturers can file for certain GMP exemptions, agency guidance states.

Executive Summary

PET AGENTS MANUFACTURERS CAN FILE FOR GMP REGS EXEMPTIONS in certain conditions under an FDA proposed rule pertaining to radiopharmaceuticals used in positron emission tomography published in the Feb. 27 Federal Register. The rule is "intended to relieve PET manufacturers, nearly all of whom are small entities, from regulations that might result in unsafe handling of PET radiopharmaceuticals...or otherwise do not enhance the safety or quality" of the drug products. Because of their short half-lives, some only minutes long, the radiotracers are generally made to fill daily demands and are not commercially distributed. The agents are often made at the same facility in which they are used.

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