FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications
FDA Law Blog
APRIL 25, 2024
By Sarah Wicks & Dara Katcher Levy — On April 24, 2024, the FDA issued a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products – Questions and Answers , (the “Revised Draft Guidance”) which replaces the Agency’s initial draft guidance issued in February 2020 (the “Initial Draft Guidance”).
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