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# FDA Wants Feedback on Drug Approval Transparency
- URL: https://www.fdaweb.com/fda-wants-feedback-on-drug-approval-transparency/
- Published: 2019-06-26T12:00:00.000Z
- Updated: 2026-09-15T01:35:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144425

FDA will receive feedback for 60 days on its Clinical Data Summary Report pilot program that is part of an effort to increase the transparency of the clinical data used in the regulatory decision-making process. A *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-13751.pdf?ref=fdaweb.com) says the agency also wants public feedback on a new integrated review template for documentation of new drug marketing applications as part of the new drugs regulatory program modernization.

Currently, the notice says, CDER provides access to action packages that include all discipline reviews for all newly-approved original NDAs and BLAs by posting the packages on the agency Web site. It notes that the packages can contain hundreds of pages and some stakeholders have difficulty navigating the documents to better understand the basis for FDA drug approvals.

To address that problem, FDA has launched a Clinical Data Summary pilot program through which parts of a sponsor’s clinical study reports are to be posted, and a new integrated template that will be used to document FDA review of NDAs and efficacy supplements. Comment is being sought on both of the efforts.