> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Modernizing Regulation Approach: Gottlieb
- URL: https://www.fdaweb.com/fda-modernizing-regulation-approach-gottlieb/
- Published: 2018-08-30T12:00:00.000Z
- Updated: 2026-09-15T00:29:03.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5142238

FDA is modernizing its overall approach to regulation to effectively advance the kinds of medical innovations that are becoming available, according to FDA commissioner **Scott Gottlieb**. In a lengthy *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2018/08/fdas-comprehensive-effort-to-advance-new-innovations-initiatives-to-modernize-for-innovation/?ref=fdaweb.com), Gottlieb says the changes, including modernizing organization of the medical product review programs, are part of the agency’s comprehensive Medical Innovation Access Plan.

Using new authorities and resources from the 21st Century Cures Act, reauthorization of user fee agreements, and the agency’s FY 2019 budget, the efforts “will enable FDA to fund creation of a cross-cutting data enterprise for the generation of evidence, and a more modern and integrated approach to the evaluation of the information, to make sure that our regulatory decisions are as flexible and sophisticated as the science driving these advances,” Gottlieb writes.

He uses the post to reflect on how the agency is creating a new operating system for innovation by modernizing clinical trials, streamlining FDA’s organization and processes to advance regulatory science, and expanding FDA’s capacity to analyze complex real-world data streams to detect early safety and efficacy signals, and to describe new policies to be announced to meet the goals. “These mutually reinforcing efforts will help FDA meet its mission of promoting and protecting public health, and they will help unlock the full public health potential of America’s public and private investments in medical research,” Gottlieb concludes.