Traduction de «une new drug application » (Français → Néerlandais) :

Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments.
This release contains forward-looking information about an agreement by Pfizer to acquire FoldRx, and about FoldRx’s product candidate tafamidis, its other clinical and preclinical development programs and its technology platform, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development; whether and when a new drug application for tafamidis will be filed with the FDA; decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for tafamidis and that may be filed for any other product candidates that may be generated by FoldRx’s technology platform as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of tafamidis and such other product candidates; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

États-Unis, une New Drug Application (NDA) est introduite auprès de la Food and Drug Administration (FDA) américaine.
te mogen brengen. In de VS wordt er een New Drug Application (NDA) ingediend bij de Amerikaanse Food and Drug Administration (FDA).

Aux Etats-Unis, la FDA a prolongé du quatrième trimestre 2010 au premier trimestre 2011 son examen d’une autorisation supplémentaire de mise sur le marché (New Drug Application NDA) pour Zometa en conjonction avec un traitement hormonal chez les femmes préménopausées atteinte d’un cancer du sein à un stade précoce.
The US FDA has extended its review of the supplemental New Drug Application for Zometa in the adjuvant (postsurgery) treatment of premenopausal women with early breast cancer in conjunction with hormonal therapy from the fourth quarter of 2010 to the first quarter of 2011.

Alors forcément, au regard de ces considérations, de ce marché qui croit à une vitesse folle et des craintes qui l'accompagnent, la toute puissante Food and Drug Administration aux Etats-Unis commence à sérieusement s'intéresser au cas des applications de santé sur les terminaux mobiles.
In het licht van deze overwegingen, van deze markt die in een razend tempo groeit en van de schrik die daarmee gepaard gaat, is het dus onvermijdelijk dat de almachtige Amerikaanse Food and Drug Administration een groeiende interesse toont voor de gezondheidstoepassingen op mobiele terminals.

[La Revue Prescrire 1999; 19:518-9; New Engl J Med 2006; 354:158-65; Drug Safety 2001; 24:921- 7; Drugs 2004; 64:2503-14; Fiche de transparence «Antimigraineux», janvier 2003 avec mises à jour; le «Projet Information Orale Indépendante sur le Médicament» (SSMG/SSPF) a publié, sous l’égide du CBIP, le document intitulé «Les médicaments anti-céphalalgiques»]
[La Revue Prescrire 1999; 19:518-9 ; New Engl J Med 2006; 354:158-65 ; Drug Safety 2001; 24:921- 7 ; Drugs 2004; 64:2503-14 ; Transparantiefiche «Geneesmiddelen bij migraine», januari 2003 met updates); het «Projet Information Orale Indépendante sur le Médicament» (SSMG/SSPF) publiceerde, onder de auspiciën van het BCFI, het document «Les médicaments anti-céphalalgiques»]

Leukotriene antagonists: new drugs for astma.
Leukotriene antagonists new drugs for astma .

Pendant 59 ans, il sera membre du New York Drug and Chemical Club.
Zijn lidmaatschap van de New York Drug and Chemical Club overspant een periode van maar liefst 59 jaar.

“Pfizer’s commitments build on our ongoing efforts to fight neglected tropical diseases, which includes the work done through our support of the International Trachoma Initiative, by our colleagues who participate in our Global Health Fellows program, and through our participation in WIPO Re: Search -- a publicprivate consortium for sharing intellectual property and expertise with the global health research community to promote the development of new drugs, vaccines and diagnostics for the treatment of neglected tropical diseases, malaria and tuberculosis.
“Pfizer’s commitments build on our ongoing efforts to fight neglected tropical diseases, which includes the work done through our support of the International Trachoma Initiative, by our colleagues who participate in our Global Health Fellows program, and through our participation in WIPO Re: Search -- a publicprivate consortium for sharing intellectual property and expertise with the global health research community to promote the development of new drugs, vaccines and diagnostics for the treatment of neglected tropical diseases, malaria and tuberculosis. “We are proud to be a part of this innovative effort to support a healthier world”.

Therapeutics Letter, June-September 2002 (via [http ...]
Therapeutics letter, june-september 2002 (via [http ...]