FDA
SPI-1005 finished Phase 3 clinical trials with positive results In 2021, I wrote a blog about an investigational new oral drug for treating Ménière’s Disease. Known as SPI-1005, it contains ebselen, a new chemical with antioxidant and anti-inflammatory activity. At the time, participants with a definite history of Ménière’s Disease were recruited for SPI-1005 Phase 3…
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OTC hearing aids will be “self-fitting,” non-prescription devices. They will be regulated by the Food and Drug Administration (FDA) but people can buy them Over-the-Counter without a prescription or the input of any professional help. Would-be users will be on their own when it comes to deciding if they qualify for these devices because they are…
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