FDA Archives - Page 10 of 17

ICYMI: FDA Approved Almost All Medical Devices in the Last Year

“The Food and Drug Administration says it approved 98 percent of all high-risk medical devices submitted during the most recent fiscal year, the highest rate in at least 15 years. The list includes heart valves, cancer tests, gastric balloons, spinal implants...

Press Release: Proposed USDA, FDA Label Changes to be Addressed at 2nd Annual Food Labeling Conference

Nestle USA, Federal Trade Commission, Chobani Among Presenting Organizations (Chicago) – Food labeling professionals will have the opportunity to discuss the most top-of-mind issues, regulations and changes at the 2nd Annual Food Labeling: Evolving...

FDA Opens Door For 23andMe To Market Some Direct-To-Consumer Genome Tests

According to Fast Company, “An FDA decision summary released today allows DNA-testing company 23andMe to market a genome test that screens for Bloom syndrome, a rare disorder that leads to a predisposition in carriers toward the development of cancer. While, on...

FDA Approves Expanded Indication for Medical Device to Treat a Form of Brain Cancer

In a press release from FDA.gov, “The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with...

ICYMI: FDA to Establish Patient Advisory Committee on Medical Devices

According to Star Tribune, “The U.S. Food and Drug Administration on Friday announced the establishment of its first-ever patient advisory committee on medical devices. The new 11-member group will include nine voting members ‘knowledgeable in areas such...

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