Product labeling


 OTC Statement of Identity Advice Given in FDA Guidance

The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not surprisingly, addresses the requirements for statements of identity and strength designations on the principal display panels (PDPs) of OTC drug products.  The guidance notes that “[T]he […]

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