jueves, 14 de julio de 2016

FDA Releases the Draft Guidance Document, "Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product"

Today, the U.S. Food and Drug Administration released a draft guidance document, "Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product." This draft guidance is a “how-to” guide to supplement previously released final guidance “In Vitro Companion Diagnostic Devices,” which defined in vitro companion diagnostic devices (IVD companion diagnostics) and set the expectation that IVD companion diagnostics and corresponding therapeutic products should be approved or cleared by the FDA at the same time.
This draft guidance provides general principles for addressing issues that may arise when codeveloping a therapeutic product and a corresponding IVD companion diagnostic. It also provides considerations for planning and executing clinical trials and successfully fulfilling FDA regulatory requirements.
This guidance is part of the FDA’s efforts to facilitate innovation in precision medicine by assisting with the codevelopment of therapeutic products and companion diagnostics. We welcome comments regarding this draft guidance. The notice of availability published in the Federal Register and will be open for 90 days from that date.
In addition, on August 18, the FDA will host a webinar to share information and answer questions about the draft guidance. More information about the webinar is available at http://www.fda.gov/CDRHwebinar.
If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

No hay comentarios: