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In the latest batch of warning letters to GLP manufacturers, the agency cited Prime Sciences, Lovega, Gram Peptides, FormPour, Guangzhou Huli Technology, Mile High Compounds, and PekCura Labs for marketing their products without FDA approval

The second criterion for establishing a device category, at 419.66(c)(2), provides that CMS determines either of the following: (1) that a device to be included in the category has demonstrated that it will substantially improve the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body part compared to the benefits of a device or devices in a previously established category or other available treatment

Importing peptides from international suppliers introduces additional variables

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