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# FDA Ends Clinical Data Summary Pilot
- URL: https://www.fdaweb.com/fda-ends-clinical-data-summary-pilot/
- Published: 2020-03-26T12:00:00.000Z
- Updated: 2026-09-14T16:08:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146426

CDER director **Janet Woodcock** says FDA has decided to end the Clinical Data Summary Pilot Program that evaluated whether disclosing certain information included in clinical study reports following approval of an NDA improves public access to drug approval information. In an online [statement](http://www.fdaweb.com/download.php?file=6483570-0--15371.pdf), Woodcock says the pilot tested a new process for selecting, redacting, and posting on the FDA public Web site summaries of the information that the agency used in making marketing approval decisions.

“After receiving useful internal and external knowledge and feedback as part of the pilot program,” Woodcock writes, “we have decided to conclude the pilot. In the interest of increasing transparency in the drug approval process, the agency has learned many best practices through the pilot that we intend to apply to future efforts.”

Woodcock says the pilot identified a potential approach that could facilitate a harmonized system for disclosing study reports based on these principles: international library, on-demand, standardized, and voluntary.

She says that as the pilot concludes, FDA’s harmonization and transparency efforts will continue.