Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet in “CDRH Sets Performance Goals to Reduce Draft Guidance Ambiguity,” by David Filmore. (Read the full version — subscription required.)

Following is an excerpt:

Bradley Merrill Thompson, an attorney with Epstein, Becker & Green who represents device, drug and health IT companies, said the creation of metrics "is a step in the right direction," but that the goals announced Jan. 8 are not aggressive enough. "Now we just need them to make bolder commitments." …

Overall, Attorney Thompson calls the reforms "incremental improvements." The Combination Products Coalition, an industry group overseen by Thompson, has been pressing for reforms to the guidance process, including in a 2012 citizen petition. Quicker resolution of draft guidances and more routine communication about guidance topics even before a draft is released are central components of the coalition's proposals, but FDA's new policies don't go far enough. Thompson says.

"We've been saying that a substantial overhaul of the guidance development process is in order," he said. "It's time to move away from a guidance development process that has fallen hopelessly behind in communicating regulatory expectations with regard to new technology.

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.