Traduction de «product labeling and risk evaluation mitigation » (Néerlandais → Français) :

The FDA discussions focus on product labeling and Risk Evaluation Mitigation Strategy (REMS) as well as a safety update, but no request for more clinical studies.
Les discussions de la FDA portent sur la notice du produit et sur la stratégie de la gestion des risques (Risk Evaluation Mitigation Strategy ou REMS) ainsi que sur la mise à jour des données sur son innocuité, mais ne requiert pas plus d’études cliniques.

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.
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 European regulation that has entered into force on 1 July 2004 stipulates that, in order to inform the consumer of possible health risks, the labelling of beverages that contain caffeine in a proportion in excess of 150 mg/l should contain the mention “high caffeine content” followed by the caffeine content expressed in mg/100 ml in the same field of vision as the name under which the product is sold (Directive 2002/67/EC).
Enfin, une réglementation européenne, entrée en vigueur au 1er juillet 2004, stipule que l’étiquetage de boissons contenant plus de 150 mg de caféine par litre doit comporter la mention « teneur élevée en caféine » et la mention de sa quantité (en mg/100 ml) dans le même champ de vision du produit afin d’avertir le consommateur des risques possibles pour la santé (Directive 2002/67/CE).