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# DTC Accelerated Approval Disclosure Study
- URL: https://www.fdaweb.com/dtc-accelerated-approval-disclosure-study/
- Published: 2019-05-07T12:00:00.000Z
- Updated: 2026-09-15T01:25:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144047

The CDER Office of Prescription Drug Promotion (OPDP) is proposing to research the presence, wording, and prominence of a disclosure communicating information related to a drug’s accelerated approval in direct-to-consumer promotional materials. A 5/8 *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-09418.pdf?ref=fdaweb.com#page=5&zoom=auto,-265,720) says FDA requires that the Indications and Usage section of approved labeling for prescription drugs include a succinct description of the limitations of usefulness in the drug and any uncertainty about anticipated clinical benefits. The labeling for accelerated approval products typically meets that requirement by including a statement in the Indications and Usage section about the product’s approval under the accelerated approval pathway, the notice says.

Because the labeling is intended for healthcare professionals, the accelerated approval information generally includes complex concepts and sophisticated wording, FDA says. Since companies often use the same language in consumer promotional materials, or don’t communicate at all the unique considerations and potential limitations in the accelerated approval process, OPDP wants to research direct-to-consumer promotional information disclosure formats on accelerated approval for a non-existent oncology product.