Outside Publication

Questions Surround FDA Orphan Drug Exclusivity Approach, Law360

February 02, 2023

Partner Jacqueline Berman and associate Nikita Bhojani wrote a Law360 Expert Analysis article on how a new US Food and Drug Administration notice—which contrasts with an Eleventh Circuit ruling on orphan drug exclusivity—makes the scope of orphan drug exclusivity periods appear uncertain.

They note that companies may want to reconsider their strategies for requesting designations.

Read the full Law360 article >>