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Category Archives: Guidance

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Biological/Biosimilar Nonproprietary Naming Guidance and Proposed Rule for Certain Proposed Nonproprietary Names for Previously-Approved Biological Product Names Published

Posted in Biological Products, Biosimilars, Guidance

ThinkstockPhotos-457742249On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products – both those previously approved and those … Continue Reading

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished Prescription Drugs: How to Exchange Product Tracing Information

Posted in Drug Supply Chain Security Act, Guidance

On December 8, 2014, FDA issued new guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.  As the title suggests, the Guidance is part of FDA’s implementation of the Drug Supply Chain Continue Reading