CDRH Industry: Reminder: FDA Webinar “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product”

On August 18, 2016, the FDA will host a webinar to share information and answer questions about the draft guidance, "Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product."

Released on July 14, this draft guidance is a “how-to” guide to supplement previously released final guidance “In Vitro Companion Diagnostic Devices,” which defined in vitro companion diagnostic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.

More information about the webinar is available at http://www.fda.gov/CDRHwebinar.

Webinar Details

Date: August 18, 2016 Time: 1:00 PM Eastern Time (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar).

NOTE: You must dial-in to hear the presentation and ask questions: Dial: 877-917-9491 passcode: 5995433 International: 1-212-287-1619 passcode: 5995433

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9340376&p=5995433&t=c   Conference number: PWXW9340376 Audience passcode: 5995433

More information about the webinar is available at http://www.fda.gov/CDRHwebinar.

Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

If you have general questions about this guidance, please contact CDRH’s Division of Industry and Consumer Education (DICE) atdice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health