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Zdrowie i gospodarka · 25/04/2024

FDA Releases Revised Draft Guidance on Promotional Labeling and Advertising for Biosimilar Products

The US Food and Drug Administration (FDA) has released a revised draft guidance for industry on promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products. The guidance aims to address questions from manufacturers and their representatives on FDA-regulated promotional communications.

Source: Federal Register — Food and Drug AdministrationOpen original release →