Proyecto europeo de introducción rápida de fármacos + OCAT
European project for flexible drug approvals moves up a gear
The European Medicines Agency (EMA) is going a step further with its "adaptive pathways" initiative, which foresees early approval of drugs for restricted patient populations based on small initial clinical trials. Approval would then be expanded progressively, based on additional studies. Alternatively, the medicine could be pulled from the market if new data throws up unexpected problems.
Fifty eight experimental drugs have been submitted as candidates for the EMA's adaptive pathways pilot project, first unveiled a year ago, and eight have been selected for the second stage.
This involves face-to-face meetings to examine the evidence needed for individual projects and includes input from health technology assessment bodies, such as Britain's National Institute for Health and Care Excellence (NICE), which decide if new drugs offer value for money.
The EMA declined to identify specific drugs or companies involved but an official said the first stage II meeting on April 7 would concern an advanced therapy product, meaning it is a medicine based on genes, cells or tissue engineering.
No tengo prácticamente duda de que es OCAT.
http://mobile.reuters.com/article/idUSL6N0WX50Q20150401?irpc=932
Sobre el adaptative pathway:
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/12/WC500179560.pdf
«Después de nada, o después de todo/ supe que todo no era más que nada.»