PET Drug Proposed Rule Clears OMB
This article was originally published in The Pink Sheet Daily
FDA's proposed rule on current good manufacturing practices for positron emission tomography drugs is headed for publication in the Federal Register following clearance by the Office of Management & Budget Aug. 30
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Proposed current good manufacturing practices requirements for positron emission tomography drugs will reflect the “unique characteristics” of radiopharmaceuticals, HHS says. The rule would build upon a draft guidance and preliminary draft proposed cGMP rule, both issued in 2002.
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