Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Combination Products Coalition Zeroes in on Autoinjectors and Personalized Medicine."

Following is an excerpt:

The Combination Products Coalition has launched an effort to obtain regulatory clarity in two specific areas: autoinjectors and personalized medicine. ...

"Our objective is to at least make sure that the FDA understands what the questions are that need to be answered," said Thompson, a partner with EBG and general counsel for the coalition.

"That might help the agency. Sometimes when they're just trying to respond to general confusion, they're not sure truly where we're struggling, the questions that we're struggling with, and I think it helps the agency to at least know where industry's struggling for a lack of clarity." ...

"One of our important motivations in this regard is that whenever we talk with FDA, it gets really tough, unless you get a little bit more specific about the products, to get clarity from the agency because combination products cover such a diverse range of products," Thompson said. ...

Thompson is hoping that the coalition's input will help provide a starting point for FDA's policymaking on the two product types. The guidance process works best, Thompson said, "when FDA starts from a clear understanding of where the industry is struggling, and I don't think industry takes the time often enough to really articulate where they're unsure of what the law is."

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.