FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States.
PLoS Negl Trop Dis
; 18(5): e0012116, 2024 May.
Article
in En
| MEDLINE
| ID: mdl-38722919
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
United States Food and Drug Administration
/
Communicable Diseases, Emerging
/
Neglected Diseases
Limits:
Humans
Country/Region as subject:
America do norte
Language:
En
Journal:
PLoS Negl Trop Dis
Journal subject:
MEDICINA TROPICAL
Year:
2024
Document type:
Article
Affiliation country: