Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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).



Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts