We’ve covered the LDT regulation evolution for some time now. To give some perspective we’ve created the following infographic showing the history of LDT regulation. To use it in your own content check out the code snippet below the infographic. We only...
For a long time now I have been pushing FDA to provide evidence to back up its claim that LDTs have introduced risk to patient populations. That evidence has now been provided, and it is compelling. FDA has just published a case for LDT regulation based on 20 case...
The U.S. House of Representatives Committee on Energy and Commerce is holding a hearing entitled “Examining the Regulation of Diagnostic Tests and Laboratory Operations” on November 17 at 2pm ET (note that the date was re-scheduled from an earlier date)....
An FDA official recently stated that the final version of the draft guidance regarding regulation of laboratory-developed tests (LDTs) is not likely to be released before the end of this year. Elizabeth Mansfield, director of personalized medicine at the FDA’s...
FDA and CMS have just announced that the agencies are forming a joint task force to explore “areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories.” This is a laudable...
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