CDER SBIA Webinar: An Overview of FDA’s Draft Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification - July 1, 2014

CDER SBIA Webinar on

“An Overview of FDA’s Draft Guidance - Drug Supply Chain Security Act Implementation:

Identification of Suspect Product and Notification.” - July 1, 2014

On Tuesday July 1, 2014, at 1PM (EDT), CDER SBIAwill host a webinar entitled “An Overview of FDA’s Draft Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.”

FDA published a notice in the Federal Register announcing the availability of the draft Guidance for Industry - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The Drug Supply Chain Security Act of 2013 requires FDA to issue draft guidance to help certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) identify suspect products,  and must begin notifying FDA if it suspects it has illegitimate product in its possession on January 15, 2015. This guidance also provides information for supply chain stakeholders about how to notify FDA when they determine that they have an illegitimate product, and how to terminate that notification, consulting with FDA, should it no longer be necessary.

The purpose of this webinar is to provide an introduction and overview of FDA’s recently issued draft guidance, “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.”  This is the first guidance issued under the Drug Supply Chain Security Act.

Additional information is located at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm402366.htm  

To register for this Event, please go the following link: https://collaboration.fda.gov/sbia0701/event/registration.html

(Registration password needs to be 8 characters and alphanumeric)

Note: Your registration acknowledgement will include the webinar access link. 

Audio will broadcast from your computer speakers.

Closed captioning will be provided.

Please note: There is a user capacity limit for this webinar. For those who cannot enter the webinar, please know that it will be recorded and a link will be posted to this page.

Questions/Comments can be submitted live via a Q/A chat window.

- Webinar access link: https://collaboration.fda.gov/sbia0701/event/registration.html

- FR Document: 2014-13544

- Docket ID: FDA-2014-D-0609

- Draft Guidance: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

  

For questions concerning the webinar, please contact CDER SBIA at:  

(866) 405-5367 | (301) 796-6707

  

CDER SBIA webinar series: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm

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The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

• Email: CDERSBIA@fda.hhs.gov
• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/cdersbia

Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation