The recent turn of events has literally put the FDA on somewhat of a hot seat...for an agency that minimally invested in technology, compared to other government entities, it is finding itself in a position of having to play "catch up" in a hurry...as evidenced with the recent turn of events allowing the Medicare files to be data mined to create a faster turn around on adverse and positive effects of pharmaceuticals instead of having to rely completely on older methodologies...it's always a question of 
when to invest and move forward, but sometimes if one waits too long, the chore to update can be a pretty monumental task versus growing one step at a time, there's a learning curve involved for all with new procedures and policies that will also rapidly change...BD
INSTITUTE OF Medicine president Harvey Fmeberg said in March that the future of personalized medicine requires "a stronger Food and Drug Administration, not a weaker Food and Drug Administration, to enhance the speed and effectiveness of personalized medicine. We need to put enough resources in the agency so that it can do its increasingly challenging and difficult assignment." He made this assessment at a meeting of the Personalized Medicine Coalition. The coalition is a group of agencies, pharma and diagnostic companies, research institutions, venture capitol groups and others focusing on genetic testing and other aspects of the up-and-coming personalized medicine arena.
Without such strengthening measures, Fineberg said, the agency may never reach the point where it can deal adequately, for example, with combinations of diagnostic and therapeutic innovations which can be part of personalized medicine.
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