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Bloomberg: FDA reorganizes to optimize industry oversight
NEW YORK — The Food and Drug Administration is reorganizing its field team within the FDA’s Office of Regulatory Affairs with a new focus on specific product areas vs. oversight of activities based on geographic regions, Bloomberg reported Monday.
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FDA expands approval for Vertex Pharmaceuticals’ cystic fibrosis drug
WASHINGTON — The Food and Drug Administration on Wednesday expanded the approved use of Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for treating cystic fibrosis. According to the FDA, the approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33, adding it based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials.