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# FDA to Publish Surrogate Endpoints List
- URL: https://www.fdaweb.com/fda-to-publish-surrogate-endpoints-list/
- Published: 2018-06-26T12:00:00.000Z
- Updated: 2026-09-15T00:16:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141769

FDA commissioner **Scott Gottlieb** says the agency will publish on its Web site in the coming weeks a list of surrogate endpoints that were the primary basis of approval or licensure of a drug or biological for both accelerated and traditional approvals. In a 6/25 [speech](https://www.fda.gov/NewsEvents/Speeches/ucm611623.htm?ref=fdaweb.com) to the National Comprehensive Cancer Network Policy Summit, Gottlieb said agency executives believe the list will help address some of the questions that have been raised about how the agency applies surrogates to make a given regulatory decision.

“We’ll also be taking steps to provide more guidance to drug developers on these novel approaches,” he said. “This includes how to design trials based on a biomarker as a novel surrogate endpoint. As one part of these efforts, we’ll be accepting requests for meetings with sponsors — called Type C meetings — earlier in the drug development process. The aim is to give sponsors explicit advice on how to design rigorous development programs under these approaches. Innovators can use these meetings to discuss the use of a biomarker as a surrogate endpoint in clinical contexts where that marker was never used as the primary basis for approval.”

Gottlieb also reported that the agency’s 2019 budget request includes $23 million to establish a new medical data enterprise for real-world data and advanced analytics, giving FDA the ability to conduct near-real-time evidence evaluation down to the level of individual electronic health records for at least 10 million individuals. He said the data would come from a broad range of healthcare settings in the U.S. for a wide range of medical products. He said the healthcare settings would be carefully selected to cover data gaps in current FDA systems. “In addition to accessing more detailed clinical data,” Gottlieb went on, “we’d also develop and apply modern computational techniques, such as natural language processing and machine learning, to more efficiently cull real time trends in the safety and effectiveness of marketed medical products.

The four major themes of Gottlieb’s address were **(1)** some of the steps FDA is taking to modernize the clinical trial process and ensure that development programs are well-suited to evaluate the more targeted therapies that increasingly form the backbone of cancer care; **(2)** how FDA is harnessing real-world data and advanced analytics to better support the regulatory approaches; **(3)** how FDA is taking new steps to enable payors and providers to leverage some of these same kinds of information and approaches to deliver more value to their patients; and **(4)** the role that payors can play in providing more open access to the significant amount of data that they have.

The common theme that links the agency initiatives, he said, is the need to modernize drug development to harness the full medical potential of this rapidly advancing science, while ensuring that innovation remains affordable for patients.