FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications
FDA Law Blog: Biosimilars
APRIL 25, 2024
This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.
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