While news about U.S. LDT regulation pops up almost weekly - there's an FDA hearing, or a legislative proposal - lab test regulation is also on the charts in Europe.
Below, the European Society for Human Genetics (ESHG) and "a range of organisations" raise concerns about in likely changes in European diagnostic test regulation.
Showing posts with label fda ldt. Show all posts
Showing posts with label fda ldt. Show all posts
Wednesday, December 9, 2015
Monday, November 16, 2015
FDA Tells World (And Hill) It Needs to Regulate LDTs
On November 16, 2015, the FDA released a detailed white paper on why LDTs need to be more stringently regulated.
The FDA Blog introduces the topic, authored by Peter Lurie (here). The FDA's homepage for the report on LDT safety and problems is here. The FDA's 39 page white paper is here and assesses potential risks and harms associated with twenty different LDT tests.
The report went up the day before FDA will testify at a Hill hearing on the need to regulate LDTs.
The FDA Blog introduces the topic, authored by Peter Lurie (here). The FDA's homepage for the report on LDT safety and problems is here. The FDA's 39 page white paper is here and assesses potential risks and harms associated with twenty different LDT tests.
The report went up the day before FDA will testify at a Hill hearing on the need to regulate LDTs.
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