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# New DTC Study on Accelerated Approval Disclosures
- URL: https://www.fdaweb.com/new-dtc-study-on-accelerated-approval-disclosures/
- Published: 2019-05-08T12:00:00.000Z
- Updated: 2026-09-15T01:25:34.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144055

*Federal Register* notice: FDA has submitted to OMB a new information collection entitled “Experimental Study of an Accelerated Approval Disclosure.” The study is intended to examine the presence, wording, and prominence of a disclosure communicating information related to the drug’s accelerated approval in direct-to-consumer promotional materials. This information includes the use of surrogate or intermediate clinical endpoints to support approval, the uncertainty about the relationship of the surrogate or intermediate clinical endpoint to the predicted clinical benefit, and the need for confirmatory trials. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-08/pdf/2019-09418.pdf?ref=fdaweb.com).