Supply chain


FDA Publishes Four Guidances on Supply Chain Security Issues

The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements. The draft and final guidances are as follows: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This […]

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Chinese people wearing surgical mask sitting in subway

Coronavirus and Drug Shortage – A Tale of Two Crises

  On February 4, 2020, FDA issued a press release regarding the issuance of an emergency use authorization (EUA) (here) to allow for emergency use of a Coronavirus diagnostic panel by Centers for Disease Control and Prevention (CDC)-qualified labs across the country.  Previously, the panel’s use was limited to only CDC laboratories.  This additional step […]

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