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For the regulatory side, read our GHK-Cu FDA approval status guide

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In March 2024, CMS issued new guidance stating that anti-obesity medications (AOMs) that receive FDA approval for an additional medically accepted indication can be considered a Part D drug for that specific use

Presented for research literature review only Bhles H et al

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12 On the day the H-WA took effect, regulatory affairs members from Bolar Pharmaceuticals drove to the FDA headquarters and hand-delivered 40 ANDAs in an effort to secure the 180-day market exclusivity granted to the first successful generic drug applicant