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1.
Determining Commonalities in the Experiences of Patients with Rare Diseases: A Qualitative Analysis of US Food and Drug Administration Patient Engagement Sessions.
Patient
; 17(1): 25-37, 2024 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-37833521
2.
Analysis of the first ten years of FDA's rare pediatric disease priority review voucher program: designations, diseases, and drug development.
Orphanet J Rare Dis
; 19(1): 86, 2024 Feb 25.
Artículo
en Inglés
| MEDLINE | ID: mdl-38403586
3.
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.
Orphanet J Rare Dis
; 18(1): 163, 2023 Jun 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-37353796
4.
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.
Orphanet J Rare Dis
; 16(1): 265, 2021 06 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-34107994
5.
Trends in drug development for amyotrophic lateral sclerosis.
Nat Rev Drug Discov
; 23(2): 99-100, 2024 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-38086894
6.
Correction to: Analysis of the first ten years of FDA's rare pediatric disease priority review voucher program: designations, diseases, and drug development.
Orphanet J Rare Dis
; 19(1): 131, 2024 Mar 21.
Artículo
en Inglés
| MEDLINE | ID: mdl-38515155
7.
Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies.
Ther Innov Regul Sci
; 53(1): 81-85, 2019 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29719976
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