Using four decades of FDA orphan drug designations to describe trends in rare disease drug development: substantial growth seen in development of drugs for rare oncologic, neurolog...

by Kathleen L. Miller, Lewis J. Fermaglich, Janet Maynard
Published 2021-06-01

Investigating the landscape of US orphan product approvals

by Kathleen L. Miller, Michael Lanthier
Published 2018-10-01

Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling

by Dionna J. Green, Kyunghun Park, Varsha Bhatt-Mehta, Donna Snyder, Gilbert J. Burckart
Published 2021-07-01

Do investors value the FDA orphan drug designation?

by Kathleen L. Miller
Published 2017-06-01