GlobalData tracks 40 years of innovation in FDA review designations

Regulatory authorities, particularly the US Food and Drug Administration (FDA), have played a crucial role in accelerating and incentivizing the development of innovative treatments through review designations.

Since the first designation in 1984, the FDA has seen a substantial rise in the number of designations granted, reaching 694 in 2020. This surge reflects key pharmaceutical milestones, including the biotech boom and the advent of ground-breaking scientific advancements over the past four decades, observes pharma analytics company GlobalData.

Jasper Morley, pharma analyst at GlobalData, commented: “To date, the FDA has implemented seven different types of review designations, which accelerate and incentivize drug development. Each designation offers specific benefits to the drugmakers. For example, the orphan drug designation (ODD) is granted to drugs intended to treat a rare condition providing tax credits for qualified clinical trials, exemptions from user fees, and a potential of seven years market exclusivity following approval.”