Zobrazeno 1 - 7 of 7 pro vyhledávání: '"Lewis J. Fermaglich"'
1
Akademický článek
Analysis of the first ten years of FDA’s rare pediatric disease priority review voucher program: designations, diseases, and drug development
Autor: Catherine Mease, Kathleen L. Miller, Lewis J. Fermaglich, Jeanine Best, Gumei Liu, Erika Torjusen
Publikováno v: Orphanet Journal of Rare Diseases, Vol 19, Iss 1, Pp 1-9 (2024)
Abstract Background The Rare Pediatric Disease (RPD) Priority Review Voucher (PRV) Program was enacted in 2012 to support the development of new products for children. Prior to requesting a voucher, applicants can request RPD designation, which confi
Externí odkaz: https://doaj.org/article/aca57dc24c7544cd812cf6066282b494
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2
Akademický článek
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
Autor: Lewis J. Fermaglich, Kathleen L. Miller
Publikováno v: Orphanet Journal of Rare Diseases, Vol 18, Iss 1, Pp 1-8 (2023)
Abstract Background Rare diseases affect more than 30 million Americans. The passage of the Orphan Drug Act (ODA) in the United States in 1983 represented a launching point for a rare disease drug development revolution for these patients. Financial
Externí odkaz: https://doaj.org/article/59aaeb22405849489c5cffc34bad6ba8
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4
Akademický článek
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
Autor: Kathleen L. Miller, Lewis J. Fermaglich, Janet Maynard
Publikováno v: Orphanet Journal of Rare Diseases, Vol 16, Iss 1, Pp 1-10 (2021)
Abstract Background Orphan drug designations are a useful proxy to investigate trends in rare disease drug development. Drug developers must receive a designation before they are eligible for the economic incentives of the Orphan Drug Act in the Unit
Externí odkaz: https://doaj.org/article/f738e0c4f7b64ba48415aa6d9b1aac59
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5
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
Autor: Janet W. Maynard, Kathleen L. Miller, Lewis J. Fermaglich
Publikováno v: Orphanet Journal of Rare Diseases, Vol 16, Iss 1, Pp 1-10 (2021)
Orphanet Journal of Rare Diseases
Background Orphan drug designations are a useful proxy to investigate trends in rare disease drug development. Drug developers must receive a designation before they are eligible for the economic incentives of the Orphan Drug Act in the United States
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::514f4e09c141754c69f19bff6618dd67
https://doi.org/10.1186/s13023-021-01901-6
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6
Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies
Autor: Lewis J. Fermaglich, Johnny Young, Eunjung Esther Chuh, Ru Chen, Julia Lee, Carol Y. Kim, Daiva Shetty, Teena Thomas, Ying Fan
Publikováno v: Therapeutic innovationregulatory science. 53(1)
The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) stud
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::11678c7bb6742766d421e45f09e91046
https://pubmed.ncbi.nlm.nih.gov/29719976
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