FDA Needs Better Postmarket Data, Not More Postmarket Authority – Schultz
This article was originally published in The Gray Sheet
Executive Summary
FDA should establish a permanent network of hospitals to collect device postmarket data while lowering the evidence standard for market approval, Harvard Clinical Research Institute Chief Scientific Officer Richard Kuntz, MD, suggests
You may also be interested in...
CMS-Supported Clinical Data Collection Worth The Cost – Tunis
CMS will seek public comments early this year on criteria for deciding which national coverage policies should include data collection requirements
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.