- December 12, 2023
- 1:00 PM - 2:00 PM ET
On December 12, 2023, the FDA held a webinar for industry and other interested stakeholders to:
- explain the scope and goals of the new voluntary pilot program for certain oncology drugs used with certain in vitro diagnostic tests, and
- describe how to complete the Center for Devices and Radiological Health’s (CDRH) templates for collecting and providing performance characteristics and validation information for clinical trial assays under the pilot program.
In June 2023, the FDA issued the final guidance, Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program, which is intended to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers, used with certain oncology drug products, should meet.
The pilot program is a new voluntary program for certain oncology drug products used with corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. Through the pilot program, the FDA will request, from drug manufacturers, performance information for the tests used to enroll patients into the clinical trials that support drug approval. Based on an assessment of that information, the FDA will post to the FDA website the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug. Through this transparency, the FDA seeks to support better and more consistent performance of certain laboratory developed tests (LDTs), with the goal of better drug selection and improved care for patients with cancer.
The FDA also launched a new web page with a series of templates that oncology drug sponsors may use to provide the data and information that should be submitted to FDA, when requested by the FDA, regarding the tests used to enroll patients into the clinical trials under the pilot program.
For additional information on this pilot program, visit Oncology Drug Products Used with Certain In Vitro Diagnostics Pilot Program.
The presentation, printable slides, and transcript are available at CDRH Learn under “In Vitro Diagnostics.”
For questions about the pilot program regarding CDRH-regulated devices and the templates, contact the Office of In Vitro Diagnostics at OncologyPilotCDRH@fda.hhs.gov.
If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org, 1-800-638-2041, or 301-796-7100.