Lewis J. Fermaglich

Statistics

Publications

Citations

237

H-Index

Active since

2021

Affiliations

United States Food and Drug Administration(Current)

Lewis J. Fermaglich is an author at United States Food and Drug Administration specializing in orphan drug development, orphan drug act, and fda drug regulation.

ORCID

Publications per year

2021–2023

Publications

A comprehensive study of the rare diseases and conditions targeted by orphan drug designations and approvals over the forty years of the Orphan Drug Act

Lewis J. Fermaglich, Kathleen L. Miller · Orphanet Journal of Rare Diseases · 2023 · 125 citations · Full text

Pharmacy, Oncology, Pharmaceutical Policy +16

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, neurologic, and pediatric-onset diseases

Kathleen L. Miller, Lewis J. Fermaglich, Janet W. Maynard · Orphanet Journal of Rare Diseases · 2021 · 93 citations · Full text

Pharmacy, Oncology, Pharmaceutical Policy +16

Drugs and biologics receiving FDA orphan drug designation: an analysis of the most frequently designated products and their repositioning strategies

Kathleen L. Miller, Selma Kraft, Abraham Ipe et al. · Expert Opinion on Orphan Drugs · 2021 · 19 citations · Full text

Pharmacy, Pharmaceutical Policy, Drug Approval Processes +15

1–3 of 3