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FDA Issues Draft Guidance on Biosimilar Interchangeability

Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” - On January 18, 2017, the US Food and Drug Administration (FDA or...more

FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages

Two new FDA guidance documents can assist both conventional beverage and liquid dietary supplement manufacturers to avoid costly mischaracterization and enforcement action. The US Food and Drug Administration (FDA or...more

The Regulation of Follow-on Biologics

What is new in the world of follow-on biologics? Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more

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