FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States
El diagnóstico de enfermedades infecciosas influye significativamente en la atención al paciente, ayudando en la identificación de brotes, la respuesta y el seguimiento de la salud pública. Sin embargo, la variedad de pruebas moleculares aprobadas por la FDA sigue siendo notablemente limitada, espec...
- Autores:
- Tipo de recurso:
- Fecha de publicación:
- 2024
- Institución:
- Universidad del Rosario
- Repositorio:
- Repositorio EdocUR - U. Rosario
- Idioma:
- eng
- OAI Identifier:
- oai:repository.urosario.edu.co:10336/42967
- Acceso en línea:
- https://doi.org/10.1371/journal.pntd.0012116
https://repository.urosario.edu.co/handle/10336/42967
- Palabra clave:
- Infectious diseases
FDA
Tropical diseases
Infectious diseases
FDA
Tropical diseases
- Rights
- License
- Attribution-NonCommercial-NoDerivatives 4.0 International
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96080ef7-0c0b-4919-b028-1f0fb8fe7b4c10117161186002024-07-08T18:58:59Z2024-07-08T18:58:59Z1/05/20241/05/2024El diagnóstico de enfermedades infecciosas influye significativamente en la atención al paciente, ayudando en la identificación de brotes, la respuesta y el seguimiento de la salud pública. Sin embargo, la variedad de pruebas moleculares aprobadas por la FDA sigue siendo notablemente limitada, especialmente en lo que respecta a las enfermedades tropicales desatendidas (ETD). Basándose en nuestra experiencia como una de las redes de atención médica más grandes en el área metropolitana de Nueva York, este manuscrito de punto de vista tiene como objetivo resaltar el panorama de diagnóstico existente y las necesidades clínicas insatisfechas para 4 enfermedades del tubo neural emergentes y cada vez más prevalentes en los Estados Unidos; además, profundiza en la posibles efectos adversos de la norma propuesta por la FDA sobre pruebas desarrolladas en laboratorio para estas afecciones clínicas y el espectro más amplio de enfermedades del tubo neural.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.application/pdfhttps://doi.org/10.1371/journal.pntd.0012116https://repository.urosario.edu.co/handle/10336/42967engManuel Schibler, University of Geneva Hospitals, SWITZERLANDPLoS Neglected Tropical DiseasesAttribution-NonCommercial-NoDerivatives 4.0 InternationalAbierto (Texto Completo)http://creativecommons.org/licenses/by-nc-sa/4.0/http://purl.org/coar/access_right/c_abf2PLoS Neglected Tropical Diseasesinstname:Universidad del Rosarioreponame:Repositorio Institucional EdocURInfectious diseasesFDATropical diseasesInfectious diseasesFDATropical diseasesFDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United StatesarticleArtículo de revisiónhttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_6501Paniz-Mondolfi A.E.Ramírez González, Juan DavidORIGINALFDAs proposed rule and its regulatory impact on emerging.pdfapplication/pdf499349https://repository.urosario.edu.co/bitstreams/2b56b7f7-4861-43bf-aafd-8635794c3c8c/download6d7f2de09fa28b0f58db14199506d2beMD51TEXTFDAs proposed rule and its regulatory impact on emerging.pdf.txtFDAs proposed rule and its regulatory impact on emerging.pdf.txtExtracted texttext/plain51704https://repository.urosario.edu.co/bitstreams/cc5d6e7d-4c66-46f8-8e7f-ad53be79f11d/download405abecf907854a65ad3a434e1c8d495MD52THUMBNAILFDAs proposed rule and its regulatory impact on emerging.pdf.jpgFDAs proposed rule and its regulatory impact on emerging.pdf.jpgGenerated Thumbnailimage/jpeg4058https://repository.urosario.edu.co/bitstreams/ca701b7f-f46b-4273-848a-ccb86a8057ac/download128f44f8cfc6f47f7b26502cd0c1483cMD5310336/42967oai:repository.urosario.edu.co:10336/429672024-07-09 03:07:29.35http://creativecommons.org/licenses/by-nc-sa/4.0/Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttps://repository.urosario.edu.coRepositorio institucional EdocURedocur@urosario.edu.co |
| dc.title.spa.fl_str_mv |
FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States |
| title |
FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States |
| spellingShingle |
FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States Infectious diseases FDA Tropical diseases Infectious diseases FDA Tropical diseases |
| title_short |
FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States |
| title_full |
FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States |
| title_fullStr |
FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States |
| title_full_unstemmed |
FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States |
| title_sort |
FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States |
| dc.subject.spa.fl_str_mv |
Infectious diseases FDA Tropical diseases |
| topic |
Infectious diseases FDA Tropical diseases Infectious diseases FDA Tropical diseases |
| dc.subject.keyword.eng.fl_str_mv |
Infectious diseases FDA Tropical diseases |
| description |
El diagnóstico de enfermedades infecciosas influye significativamente en la atención al paciente, ayudando en la identificación de brotes, la respuesta y el seguimiento de la salud pública. Sin embargo, la variedad de pruebas moleculares aprobadas por la FDA sigue siendo notablemente limitada, especialmente en lo que respecta a las enfermedades tropicales desatendidas (ETD). Basándose en nuestra experiencia como una de las redes de atención médica más grandes en el área metropolitana de Nueva York, este manuscrito de punto de vista tiene como objetivo resaltar el panorama de diagnóstico existente y las necesidades clínicas insatisfechas para 4 enfermedades del tubo neural emergentes y cada vez más prevalentes en los Estados Unidos; además, profundiza en la posibles efectos adversos de la norma propuesta por la FDA sobre pruebas desarrolladas en laboratorio para estas afecciones clínicas y el espectro más amplio de enfermedades del tubo neural. |
| publishDate |
2024 |
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1/05/2024 |
| dc.date.issued.spa.fl_str_mv |
1/05/2024 |
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2024-07-08T18:58:59Z |
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2024-07-08T18:58:59Z |
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article |
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http://purl.org/coar/version/c_970fb48d4fbd8a85 |
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Artículo de revisión |
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https://doi.org/10.1371/journal.pntd.0012116 |
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https://repository.urosario.edu.co/handle/10336/42967 |
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https://doi.org/10.1371/journal.pntd.0012116 https://repository.urosario.edu.co/handle/10336/42967 |
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eng |
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eng |
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PLoS Neglected Tropical Diseases |
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Attribution-NonCommercial-NoDerivatives 4.0 International |
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http://purl.org/coar/access_right/c_abf2 |
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Abierto (Texto Completo) |
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http://creativecommons.org/licenses/by-nc-sa/4.0/ |
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Attribution-NonCommercial-NoDerivatives 4.0 International Abierto (Texto Completo) http://creativecommons.org/licenses/by-nc-sa/4.0/ http://purl.org/coar/access_right/c_abf2 |
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application/pdf |
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Manuel Schibler, University of Geneva Hospitals, SWITZERLAND |
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PLoS Neglected Tropical Diseases |
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Universidad del Rosario |
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