Similar to Goldilocks searching for porridge that is neither too hot nor too cold in the classic 19th-century fairytale, Goldilocks and the Three Bears, the Food and Drug Administration is looking for an approach to rare disease drug development that is just right. The agency recently launched the Rare Disease Framework Initiative to create a fit-for-purpose process for developing and reviewing rare disease drugs and biologics, recognizing the unique challenges associated with small patient…
By: Arnall Golden Gregory LLP
By: Arnall Golden Gregory LLP
