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 "Industry Seeks More Clarity Following Combo Product GMP Final Rule."

Following is an excerpt:

The industry Combination Products Coalition generally agrees with the content of FDA's final rule on combination product current good manufacturing practices, but says the rule lacks details on implementation and scope. ...

"It seems as though we're largely in agreement," said Bradley Thompson, an attorney at Epstein Becker Green in Washington, D.C., and chief counsel for the coalition, which represents around 20 different device, drug and biologic firms. "FDA typically seemed to look at our comments and agree with what the interpretation ought to be."

However, he said in an interview, "What they didn't do is say that it was worth editing their rule" to address industry requests for more clarification on various points. "In a sense that's fine, I don't care where the clarification occurs as long as we're all on the same the page and for the most part we see seem to be on the same page."

Thompson says his group is anxiously awaiting the release of a companion guidance document explaining how the rule should be implemented. He says with the release of the rule, he hopes FDA will be more responsive to industry cGMP inquiries. Communication between FDA and industry has been stifled for the past five or six years, he says, because FDA has been in rulemaking mode and couldn't address specific questions on GMP for combo products.

"So now that the rule's final, we're kind of ready to go into overdrive in implementation," Thompson said. "That's why we're really hoping to see a guidance document very soon because we really need our practical questions answered before we can do what FDA wants us to do to implement this rule," Thompson said. ...

Thompson took issue with the fact that the draft guidance did not address changes made to other application types, including 510(k)s or abbreviated new drug applications.

"Basically what we're concerned about is that it really increases the number of submissions for device changes. The reason is very simple: this guidance will treat every device part as though it's a PMA device," he said.

"This guidance tells us to treat every device change as though it's a class III device change. We're very concerned that this up-regulates the device portion of the product and will require many more submissions. No only many more, but of very expensive kind," he added.

His group plans to submit comments on the draft guidance, which are due April 22.

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.