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# FDA Explains Surrogate Endpoint Table
- URL: https://www.fdaweb.com/fda-explains-surrogate-endpoint-table/
- Published: 2020-12-14T12:00:00.000Z
- Updated: 2026-09-14T16:40:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148291

A new [FDA Web site posting](https://www.fda.gov/drugs/regulatory-science-action/public-posting-comprehensive-surrogate-endpoint-table-cder-and-cber-regulated-products?ref=fdaweb.com) discusses the agency’s [surrogate endpoint (SE) table](https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure?ref=fdaweb.com) that was mandated by the 21st Century Cures Act of 2016\. The table is intended to increase transparency by informing stakeholders about the development of novel SEs. “It also provides consistency in the application of existing endpoints to drug development programs, thus expediting drug development according to comprehensive criteria,” the posting says. The listing can also assist in identifying potential case studies for developing scientific policy around the acceptability of novel SEs, it says.

While the Cures Act called for a list of those SEs used in traditional and accelerated approvals, FDA staff expanded the listing to include SEs indentified in meeting minutes from 2,444 end-of-phase-2 meetings, 219 special protocol assessment meetings, and from guidance documents. “We also relied on previous SE compilation efforts and divisional knowledge, especially for SEs in disease categories for which no new drug had been developed for some time (e.g., conditions related to thyroid disease ),” the agency says.

In providing the listing, FDA also says it focused on providing consistency across review division areas of expertise. “This consideration, along with the goal of providing data as efficiently as possible, resulted in five column headings: disease/use, patient population, surrogate endpoint, type of approval appropriate for (accelerated or traditional), and drug mechanism of action,” it says. “For each entry (i.e., row), the disease/use and patient population columns combined represent the indication in general terms. For the sake of conciseness, detailed qualifiers, such as time points for measurement, rates, and population characteristics were excluded whenever appropriate. Enough flexibility was nevertheless built into the table to allow for important details to be captured as appropriate for the given disease area.”