FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications By Sarah Wicks & Dara Katcher Levy —

https://www.thefdalawblog.com/2024/04/fdas-revised-draft-guidance-on-biological-product-promotion-provides-additional-recommendations-clarifications/?utm_source=rss&utm_medium=rss&utm_campaign=fdas-revised-draft-guidance-on-biological-product-promotion-provides-additional-recommendations-clarifications On April 24, 2024, the FDA issued a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products – Questions and Answers, (the “Revised Draft Guidance”) which replaces the Agency’s initial draft guidance issued in February 2020 (the “Initial Draft Guidance”). https://www.fda.gov/media/134862/download