
The FDA is urged to collaborate with relevant payers to reclassify transdermal dietary supplement patches as unapproved drug products, prompting potential recalls for noncompliant items. This shift is crucial as it addresses the significant regulatory risks associated with 24 patch products and GLP-1 patches that currently fall outside legal supplement channels, exposing both manufacturers and users to safety liabilities. As the demand for alternative obesity therapies grows, ongoing legal ambiguities complicate the landscape, necessitating immediate guidance and action.

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“Their development, from the early identification of exendin-4 in Gila-monster venom to the creation of long-acting analogues and the first oral peptide, marks a significant step in translational drug design.”

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“This review integrates molecular evolution, formulation advances, and biopharmaceutics modeling, including physiologically based biopharmaceutics modeling (PBBM), to illustrate emerging strategies shaping next-generation oral peptide therapeutics.”