Does a State approve a test or FDA? It's unsettling that a gov can set the medical rules or decide what the clinical trials should be. Is he a DR?
The company developing/ producing the pharmaceutical designs the clinical testing protocol to meet the CFR210/211 requirements. Claims of efficacy are made by the people marketing the product and they have to support that with the clinical data.
The FDA will review the information when it is submitted for approval and determine if the regulations have been met. Approve/Deny/Request more information - those are the replies the FDA will give to the company submitting.
Even if it is a hospital/college submitting the study they are doing so as an entity that will then license their work - maybe for free, but usually for a fee or %.
For neither Pharma or devices will the FDA state that a claim is being met by a product. They will only state that the product meets the regulatory submission requirements and that it may be marketed. FDA approved doesn’t mean anything beyond it’s been submitted to the FDA for approval to market and the FDA says it meets the regulatory requirements with the data submitted. Doesn’t mean the FDA supports the claim.