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background package

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05:54 Feb 10, 2009
This question was closed without grading. Reason: Answer found elsewhere

English to Spanish translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: background package
En las pautas para presentar una solicitud de nombre comercial a la FDA:
"As with all documentation provided to the FDA, the quality of a background package is greatly improved with adequate review from all necessary functional areas as well as outside experts. The success of an FDA meeting is dependent on the FDA's ability to read and understand the background package."

Gracias por sus sugerencias.
Spring Moon
Local time: 08:01
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Summary of answers provided
4 +1antecedentes
Libe de las Fuentes
4paquete de antecedentes
Darío Orlando Fernández
4datos/documentos de trasfondo
TransRight
3informe
Marina Menendez
3documentos de información básica / documentos con los antecedentes
Margarita Ezquerra (Smart Translators, S.L.)


Discussion entries: 1





  

Answers


54 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
datos/documentos de trasfondo


Explanation:
Al igual que toda documentación provista a la FDA, se puede mejorar mucho la calidad de los datos/documentos de trasfondo por...

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Note added at 55 mins (2009-02-10 06:50:02 GMT)
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http://www.allbusiness.com/legal/health-care-law-drug-medica...

TransRight
Local time: 06:01
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57 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
informe


Explanation:
No estoy segura de la traducción al español pero al menos puedo ayudarte con el significado.



Following receipt of a fast-track designation from the FDA in July 2005, .... Briefing document (background package) from Merck for FDA Antiviral Drugs ...
econnect.uspharmacist.com/econnect/Default.aspx?tabid=53&page=publish/content/8_2139.htm - 89k


...This study will be discussed at the meeting itself and the report as published is contained in this background package...
http://www.fda.gov/ohrms/dockets/AC/07/briefing/2007-4308b1-...



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Note added at 1 hr (2009-02-10 06:58:11 GMT)
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Estuve investigando y parece que la traducción es simplemente "informe". En el sig link hay un modelo:


RITUXIMAB
en artritis reumatoide
Informe para el Comité de Actualización de la
Guía Farmacoterapéutica de Hospitales de Andalucía
16/12/2006
http://www.juntadeandalucia.es/servicioandaluzdesalud/conten...

Marina Menendez
Argentina
Local time: 10:01
Native speaker of: Native in SpanishSpanish
PRO pts in category: 120
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2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
antecedentes


Explanation:
El contenido en inglés se comprende bien, pero encontrar el término descriptivo en castellano es más complicado. Y se debe al término "background" que en lo que respecta a información significa antecedentes, datos previos, etc. El término "de fondo" se emplea más para música, ambiente, etc.


Example sentence(s):
  • What is ‘background information’? It’s reading up on the subject before you make too many decisions about how you’re going to approach your research. It introduces you to a topic before you dive in, pretending to be an expert.
Libe de las Fuentes
Local time: 15:01
Works in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 8

Peer comments on this answer (and responses from the answerer)
agree  Laura_Fazio : Concise. I like it.
7 hrs
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2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
documentos de información básica / documentos con los antecedentes


Explanation:
Suerte

Margarita Ezquerra (Smart Translators, S.L.)
Spain
Local time: 15:01
Native speaker of: Native in SpanishSpanish
PRO pts in category: 274
Login to enter a peer comment (or grade)

3 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
paquete de antecedentes


Explanation:
Parece que la duda reside en la palabra "package". Pues bien, se trata simplemente de "paquete" y se utiliza cuando se presentan antecedentes, propuestas, planes de acción, etc (eg.: "paquete de medidas económicas para paliar la crisis económica") de diversa índole y referidas a distintas áreas de incumbencia.

Darío Orlando Fernández
Argentina
Local time: 10:01
Native speaker of: Native in SpanishSpanish
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