FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States.

Autor:	Alberto E Paniz-Mondolfi, Juan David Ramírez
Jazyk:	angličtina
Rok vydání:	2024
Předmět:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Zdroj:	PLoS Neglected Tropical Diseases, Vol 18, Iss 5, p e0012116 (2024)
Druh dokumentu:	article
ISSN:	1935-2727 1935-2735
DOI:	10.1371/journal.pntd.0012116&type=printable
Popis:	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.
Databáze:	Directory of Open Access Journals
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