Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “FDA Ignores Advamed Requests in Final RWE Device Guidance,” by David Lim.

Following is an excerpt:

FDA’s recently finalized guidance on real-world evidence appears to have not heeded calls from the device industry to provide additional examples of how RWE applies to class II medical devices and in vitro diagnostic devices. …

“I think at least some people wanted a sort of a cookie-cutter approach, with the guidance laying out very specifically what sponsors could accomplish with real-world data from a regulatory decision standpoint. But I’m sympathetic with FDA, because as I think about the incredible variety of uses of RWD, there’s just no way to cover that variety in a single guidance document. Further, frankly it’s early in our experience with RWD to fully appreciate all of the nuances of the use of that data in regulatory decision-making. I actually think FDA has done a relatively good job of laying out a very broad and admittedly high level framework for analyzing data. What impresses me is FDA’s apparent open-mindedness about the wide variety of uses of RWD,” Brad Thompson, attorney at Epstein, Becker & Green, told IHP.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.