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  3. Medical: Pharmaceuticals

post-approval commitment to the FDA

French translation: étude post-commercialisation (pour la FDA)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:post-approval commitment to the FDA
French translation:étude post-commercialisation (pour la FDA)
Entered by: colette siorat

18:55 Jan 15, 2008
English to French translations [PRO]
Medical - Medical: Pharmaceuticals / Compte-rendu d'études cliniques
English term or phrase: post-approval commitment to the FDA
The comparison of the two combination therapy doses was conducted as a post-approval commitment to the U.S. Food and Drug Administration.

D'avance merci pour votre aide.
stefd (X)
Local time: 08:43
étude post-commercialisation (pour la FDA)
Explanation:
Dans certain cas, la FDA valide un produit à condition qu'une étude post-commercialisation soit entreprise. Cette question a déjà été posée...geo.proz.com/kudoz/1666818
Selected response from:

colette siorat
France
Local time: 08:43
Grading comment
c'est ce qui correspond le plus à mon texte et vous indiquez le même type question avait déjà été posée
Merci
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2engagement post-approbation de la FDA
Catherine Antheunissens
4étude post-commercialisation (pour la FDA)
colette siorat
4étude (de dosage en association) post amm ou post agrément FDA
Drmanu49


Discussion entries: 1





  

Answers


10 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
post-approval commitment to the fda
engagement post-approbation de la FDA


Explanation:
La FDA est l'institution américaine qui autorise ou non le lancement de nouveaux produits pharmaceutiques sur le marché. En phase 4, tout nouveau produitt doit être soumis à l'approbation de la FDA avant d'être commercialisé.

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Note added at 11 mins (2008-01-15 19:07:23 GMT)
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"produit" avec un seul "t" bien sûr..


    Reference: http://www.ic.gc.ca/epic/site/p-pp.nsf/fr/ph01712f.html
Catherine Antheunissens
Spain
Local time: 08:43
Specializes in field
Native speaker of: French

Peer comments on this answer (and responses from the answerer)
agree  Christiane Bujold
1 hr
agree  GILLES MEUNIER
18 hrs
neutral  Drmanu49: engagement ???
2 days 1 hr
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
post-approval commitment to the fda
étude post-commercialisation (pour la FDA)


Explanation:
Dans certain cas, la FDA valide un produit à condition qu'une étude post-commercialisation soit entreprise. Cette question a déjà été posée...geo.proz.com/kudoz/1666818

colette siorat
France
Local time: 08:43
Specializes in field
Native speaker of: Native in FrenchFrench
PRO pts in category: 28
Grading comment
c'est ce qui correspond le plus à mon texte et vous indiquez le même type question avait déjà été posée
Merci
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
post-approval commitment to the fda
étude (de dosage en association) post amm ou post agrément FDA


Explanation:
Il a considéré que le développement des études post-AMM doit être encouragé. ... M. François Autain a cité une étude de l'association américaine Public ...
www.senat.fr/commission/soc/medicament051202.html - 25k -

Drmanu49
France
Local time: 08:43
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 1923
Login to enter a peer comment (or grade)



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