What is the difference between FDA cleared vs. FDA approved?
FDA approval is a more rigorous process and is required for any prescription medication brought to the market for use in the US. For example: for a new acute medication for the treatment of migraine (examples Ubrelvy, Nurtec, and Reyvow)-efficacy that is statistically significant over placebo has to be demonstrated. Safety also has to be proven in long-term safety trials. In comparison, devices such as Cefaly and Nerivio only need FDA clearance to be available for use in the US. The standards for getting FDA clearance are not as rigorous. These devices have to demonstrate a good safety profile but the requirements for efficacy over placebo are not as strict.
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