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Who gives Information to FDA?

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If we want low dose Naltrexone (fast-acting) to get FDA approval who

sends the information to them? I am sure my doctor is keeping

records of my usage, but how does this get to back to the Federal

Drug Administration? Or does the studies have to promoted by FDA?

Does anyone have any idea of when it will be ready to be prescribed

like most other drugs? Many people are not willing to try the drug

because of this glitch, this drug, not being FDA approved.

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