Democrats blast FDA labeling proposal
This article was originally published in The Gray Sheet
Executive Summary
Eight Democratic representatives and senators urge FDA Jan. 23 not to finalize a proposed rule in which the agency seeks to "reaffirm" the limited authority drug and device firms have in altering labels without approval (1"The Gray Sheet" Jan. 21, 2008, p. 6). The lawmakers write that the proposal is "part of a pattern of actions in the Bush administration's final months to permanently insulate the drug and device industry from liability [for unsafe products].
You may also be interested in...
Firms Have Little Leeway To Change Labels Without Approval, FDA Asserts
FDA is reiterating that a drug or device manufacturer may amend product labeling without prior agency approval only if it has "newly acquired" safety information about the product. In addition, the agency says companies may strengthen contraindications and warnings "only if there is sufficient evidence of a causal association with the drug, biologic, or device.
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.