FDA Updates Draft Guidance on Promotional Labeling and Advertising Considerations for Biological Reference Products and Biosimilars

On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products – Questions and Answers (hereafter, “Revised Draft Guidance”)....
By: King & Spalding

Array