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Archive for July, 2013

CBER’s Direct Recall Classification Program Webinar: Materials Available

July 30, 2013 11 comments

Thank you to all who were able to participate in FDA’s July 25th webinar that explained the Direct Recall Classification (DRC) program and its importance to consumers.  Laura Hieronymus, Senior Recall Coordinator with the Office of Compliance and Biologics Quality in FDA’s Center for Biologics Evaluation and Research, discussed the importance of timely recall information for consumers and the impact DRC has had on speeding up the information flow between industry and FDA.

For those unable to attend, presentation slides and an archived version of the presentation is available on the FDA Basics website.

Thank you again and we hope you are able to join us for the next FDA Basics webinar!

Upcoming Webinar Thursday, July 25 – CBER’s Direct Recall Classification Program

July 22, 2013 11 comments

Do you know the vital role that FDA plays in product recalls and how the Direct Recall Classification program gets recall information to consumers in a more timely manner?

Consumers are impacted by FDA-regulated products every day. Conducting a recall is an effective way for a firm to remove or correct a violative, and possibly dangerous, product from the market. FDA advises firms on their recall strategies and monitors their recall to determine whether it is effective. FDA also publicizes recalls so consumers and health professionals can find out what types of products are being recalled.

On Thursday, July 25th, FDA will host a webinar that explains the Direct Recall Classification (DRC) program and its importance to consumers. Laura Hieronymus, Senior Recall Coordinator with the Office of Compliance and Biologics Quality in FDA’s Center for Biologics Evaluation and Research, will discuss the importance of timely recall information for consumers and the impact DRC has had on speeding up the information flow between industry and FDA.

After the presentation, there will an opportunity to ask questions.

To join the meeting July 25th:

Click the following URL – https://collaboration.fda.gov/r92694857/1
(or cut and paste it into your internet browser).
Click the “Enter as a Guest” button, fill in your name, then click “Enter Room.”
You will need computer speakers to listen to the webinar. Closed captioning will be available.

There are a limited number of spots available for the webinar. Materials from the webinar will also be available on the FDA web site.

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