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Proactive compliance reviews of promotional materials may help reduce regulatory risk as FDA continues to monitor this evolving market. Rebecca Zadaka, Associate Attorney, Gardner Law How Gardner Law Can Help FDAs recent warning letters underscore the regulatory risk associated with compounded GLP-1 marketing, particularly where promotional claims overstate product status, safety, effectiveness, or comparability to approved drugs

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Regarding thyroid effects: animal studies with GLP-1 receptor agonists have identified C-cell changes in rodents, but the clinical relevance of these findings in humans has not been established

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