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doi: 10.1016/j.phymed.2015.07.009 108 JinSYunHJJeongHYOhYNParkHJYunSGet al

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Why the FDA Position Is What It Is The regulatory reasoning behind peptide category adjustments is typically a combination of: Absence of sufficient human clinical trial data to support inclusion Manufacturing and quality control standardization questions The availability of alternative therapies Pharmacovigilance considerations arising from compounding pharmacy use patterns A physician hearing not approved about a compound that has been clinically useful may understandably feel that the regulatory posture is out of step with clinical experience

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