FDA partners with the medical community, it is medical professionals who sit on the adcom committees to advise FDA whether to approve a new product or not based on the risk/reward analysis shared by FDA and the sponsoring company.
Peer review is a time honored process which has been used to vet medical science advances within and throughout the medical community, providing FDA the knowledge that it is not solely the sponsoring company making such claims, but that the claims are agreed upon within the medical community.
Of course peer reviewed publication does not by itself accomplish approval, but it is a concrete step to show medical community support.
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