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Lewis Fermaglich
Lewis Fermaglich
在 fda.hhs.gov 的电子邮件经过验证
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引用次数
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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 …
KL Miller, LJ Fermaglich, J Maynard
Orphanet Journal of Rare Diseases 16, 265, 2021
682021
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
LJ Fermaglich, KL Miller
Orphanet Journal of Rare Diseases 18 (1), 163, 2023
352023
Drugs and biologics receiving FDA orphan drug designation: an analysis of the most frequently designated products and their repositioning strategies
KL Miller, S Kraft, A Ipe, L Fermaglich
Expert opinion on orphan drugs 9 (11-12), 265-272, 2021
162021
Salmonella cervical lymphadenitis in an immunocompetent child exposed to a Snake at an educational exhibit: a case report
LJ Fermaglich, JM Routes, PS Lye, SC Kehl, PL Havens
Infectious Diseases in Clinical Practice 20 (4), 289-290, 2012
52012
Determining commonalities in the experiences of patients with rare diseases: A qualitative analysis of us food and drug administration patient engagement sessions
C Mease, LJ Fermaglich, K Jackler, S Shermer, KL Miller
The Patient-Patient-Centered Outcomes Research 17 (1), 25-37, 2024
22024
Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies
LJ Fermaglich, R Chen, CY Kim, EE Chuh, T Thomas, D Shetty, J Lee, ...
Therapeutic Innovation & Regulatory Science 53 (1), 81-85, 2019
12019
The Orphan Drug Act and rare cancers: a retrospective analysis of oncologic orphan drug designations and associated approvals from 1983-2022
AV Ipe, LJ Fermaglich, S Kraft, C Mease, T Le, KL Miller
Expert Opinion on Orphan Drugs 12 (1), 12-18, 2024
2024
Analysis of the first ten years of FDA’s rare pediatric disease priority review voucher program: designations, diseases, and drug development
C Mease, KL Miller, LJ Fermaglich, J Best, G Liu, E Torjusen
Orphanet journal of rare diseases 19 (1), 86, 2024
2024
Trends in drug development for amyotrophic lateral sclerosis
S Kraft, C Mease, D Jillapalli, LJ Fermaglich, KL Miller
Nature Reviews Drug Discovery 23 (2), 99-100, 2024
2024
Ready or Not?
A BIOTERRORISM
2004
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