Whether clinical trials are required for FDA approval of an FoB application under the new 351(k) pathway is at the sole discretion of the FDA. However, I think it’s reasonable to assume that at least one small randomized trial will be needed in all cases.
For FDA approval of an interchangeable FoB, a so-called switching trial will certainly be needed to ensure that patients can be switched from the brand to the FoB without any adverse consequences.
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