Artikel ; Online: FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States.
PLoS neglected tropical diseases
2024 Band 18, Heft 5, Seite(n) e0012116
Abstract: Diagnosing infectious diseases significantly influences patient care, aiding in outbreak identification, response, and public health monitoring. However, the range of FDA-approved molecular tests remains notably limited, especially concerning neglected ... ...
Abstract | Diagnosing infectious diseases significantly influences patient care, aiding in outbreak identification, response, and public health monitoring. However, the range of FDA-approved molecular tests remains notably limited, especially concerning neglected tropical diseases (NTDs). Drawing upon our experience as one of the largest healthcare networks in the greater New York metropolitan area, this viewpoint manuscript aims to spotlight the existing diagnostic landscape and unmet clinical needs for 4 emerging NTDs increasingly prevalent in the United States, additionally, it delves into the possible adverse effects of the FDA's Proposed Rule on Laboratory-Developed Tests for these clinical conditions and the broader spectrum of NTDs. |
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Mesh-Begriff(e) | United States/epidemiology ; Neglected Diseases/epidemiology ; Humans ; United States Food and Drug Administration/legislation & jurisprudence ; Communicable Diseases, Emerging/epidemiology ; Tropical Medicine |
Sprache | Englisch |
Erscheinungsdatum | 2024-05-09 |
Erscheinungsland | United States |
Dokumenttyp | Journal Article ; Review |
ZDB-ID | 2429704-5 |
ISSN | 1935-2735 ; 1935-2735 |
ISSN (online) | 1935-2735 |
ISSN | 1935-2735 |
DOI | 10.1371/journal.pntd.0012116 |
Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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