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).
You may also be interested in...
Israel's Gamida Cell Survives By Selling To Lender
Having finally secured US approval for Omisirge, Gamida was hoping to bag a strategic partner for the cell therapy. A year on, no suitable partner has been identified and the firm is delisting from the NASDAQ and going private.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.