STUDIES

Our Commitment to Innovative Care:

The Wellness Institute is committed to facilitating access to advanced and alternative treatments that fall under the provisions of the Right to Try (RTT) Laws. These laws, enacted to help patients who have exhausted conventional treatment options, empower patients and their doctors to utilize:

- Pharmaceuticals off-label, and

- Biological-based treatments that have not yet received full FDA approval, with protection from liability for physicians and manufacturers.

FDA Guidance on Right to Try Annual Reporting:

The FDA has published a final rule titled Annual Summary Reporting Requirements Under the Right to Try Act, which outlines the content and deadlines for annual reports submitted by manufacturers or sponsors who provide investigational drugs under the Right to Try Act.

- CDER-Regulated Products: Manufacturers or sponsors of CDER-regulated drugs or biological products must submit their annual summary using Form FDA 5023, which is uploaded via the CDER NextGen Portal (the Portal). Registration and login are required before submission. After registering, sponsors will gain access to resources such as the CDER NextGen Portal Registration Instructions Video and the FDA Alternate Submission for Right to Try Quick Reference Guide.

- CBER-Regulated Products: Manufacturers and sponsors of CBER-regulated biological products should continue submitting annual summaries using Form FDA 5023 by emailing [email protected].

Examples of Relevant Cases:

The following video links provide examples of the types of cases that demonstrate the potential impact of these alternative treatments: