dimarts, 22 de juliol del 2014

A hole in the FDA's approval process for pediatric drugs




Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.






By Tom Ulrich


You'd think drugs meant to be taken by children for years would be studied in children for a long time to measure their long-term safety.


You'd think drugs for a condition affecting millions of children would be tested in many, many children to catch any rare side effects.


You'd think all this would happen before the Food and Drug Administration, an agency known for its strict criteria, approved them for marketing.




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