Enforcement Date Rolled Back One Year for Elements of Drug Supply Chain Security Act

BOB POLLOCK | July 2, 2017

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FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers the guidance explains what a product identifier is and how enforcement discretion will be applied. FDA addresses the fundamental issue of what a product identifier is and why some firms will likely not be able to meet the initial full implementation date for having this information on the individual product labels.

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Elixeon Pharmaceuticals is a speciality oncology company focused on the development and commercialization of targeted cancer therapies for adult and pediatric patients.

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