ConsortiEX Blog

FDA Issues New Guidance on Suspect and Illegitimate Product

The FDA recently issued guidance on the definition of Suspect and Illegitimate Products, set forth in the Federal Food Drug and Cosmetic Act1. This guidance aims to assist trading partners in putting systems in place to identify and handle suspect and illegitimate products, meeting Drug Supply Chain Security Act[...]

Recent FDA Guidance Sparks Concerns from Industry Leaders

Several key industry players have issued responses to the FDA in regard to the recent draft guidance on the use of Product Identifiers, and the policy on grandfathered product, in compliance with the Drug Supply Chain Security Act (DSCSA).

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