CDER SBIA to hold webinar on US FDA’s draft guidance on Drug Supply Chain Security Act

CDER SBIA will host a webinar entitled ‘An Overview of FDA’s Draft Guidance – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification’ on July 1, 2014, at 1PM (EDT).

FDA published a notice in the Federal Register announcing the availability of the draft Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The Drug Supply Chain Security Act of 2013 requires FDA to issue draft guidance to help certain trading partners (manufacturers, re-packagers, wholesale distributors, and dispensers) identify suspect products, and must begin notifying FDA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The purpose of this webinar is to provide an introduction and overview of FDA’s recently issued draft guidance, ‘Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.”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.

EP News Bureau-Mumbai