Gottlieb: FDA To Unveil Policy Roadmap, Update Pre-Clinical Science Policies

Friday, September 8, 2017

FDA plans to unveil a new Strategic Policy Roadmap outlining the agency's policy priorities, one of which will be rolling out new pre-clinical science policies aimed at streamlining the investigational new drug and biologics license application filing processes, Commissioner Scott Gottlieb told a diverse group of patient advocates, members of the drug and device industry, medical experts and other stakeholders during Research!America’s 2017 National Health Research Forum on Thursday (Sept. 7).

Gottlieb said the roadmap “will serve as an organizing framework -- a strategic plan for unveiling and advancing the major policy efforts we plan to undertake across all of our centers.”

The FDA chief said FDA will encourage drug developers to hold early meetings with the agency so that reviewers can provide early feedback on applications, as part of the agency’s Medical Innovation Access Plan and upcoming strategic roadmap's goal of improving the agency's engagement with product developers.

“It’s been FDA’s experience that some sponsors sometimes overestimate the amount of information needed to file an IND, and that too many of the costs of development therefore get front-loaded, increasing the cost of initiating new science. Ideally, it would be easier to get products into development, with more of the costs pushed further out, after some of the initial pre-clinical work is already done, and there’s a better understanding of whether a new product has clinical promise,” Gottlieb said.

Gottlieb added that FDA’s Center for Biologics Evaluation and Research (CBER) will be creating educational materials about its approach to pre-clinical engagement.

“CBER, under the leadership of Dr. Peter Marks, will be further clarifying to academic and industrial developers how we will foster the development of innovative products through the kinds of early substantive interactions that I described earlier. These new approaches to pre-clinical scientific engagement will also be featured in educational materials that we’ll be making available to sponsors. Our drug center has been implementing similar approaches to the pre-clinical process,” the agency head said. (subscription required)

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