The most experienced test developers get their tests through the process of FDA approval or clearance 70 days faster on average and 90 days faster on median. The first quartile (bottom of box) Third quartile (top of box) The median (horizontal line within box) The...
The FDA review process has a major impact on the time-to-market for tests and, therefore, on diagnostic companies’ willingness to invest in developing innovative tests for submission. The development of innovative diagnostic tests is critical to delivering on...
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)....
President Obama is pushing the term “Precision Medicine.” I was already pretty comfortable with the existing name for the movement, “Personalized Medicine,” but for a brief time bought into using the President’s term instead. Precision Medicine does...
This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Cookie settingsACCEPT
Privacy & Cookies Policy
Privacy Overview
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
