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FDA PET guidance vacated by Federal appeals court; policy required formal rulemaking.

This article was originally published in The Gray Sheet

Executive Summary

FDA's PET GUIDANCE NEEDED PUBLIC NOTICE; AGENCY VIOLATED FEDERAL LAW, Washington, D.C. appeals court determines Oct. 28, reversing a district court summary judgment in Syncor International Corp., et al. v. Donna E. Shalala, et al. The lower court had found that although FDA's February 1995 guidance on positron emission tomography radiopharmaceuticals was not a guidance but an interpretive rule, it was not required to give notice of proposed rulemaking to the public ("The Gray Sheet" March 17, p. 9).

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