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Food and Drug Administration--Press Releases
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Press releases from FDA
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FDA and industry reach agreement in principle on medical device user fees
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.
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FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today?s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
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FDA approves Kalydeco to treat rare form of cystic fibrosis
The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
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FDA takes action against New York cheese manufacturer
The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.
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FDA approves new treatment for most common type of skin cancer
Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).
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