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Jihad Kudsi, MD, MBA, DABOM, FACS | Bariatric Surgeon & Obesity Medicine Physician 430 Pennsylvania Ave

We conducted experiments according to the regulations covering animal experimentation within the European Union (European Communities Council Directive 86/609/EEC) and within the German Animal Welfare Act, and were approved by the German animal welfare authorities (Regierungsprsidium Karlsruhe)

The Phase 3 program spans several distinct populations and endpoints, a design strategy that reflects both the breadth of retatrutide's potential indications and the regulatory necessity of demonstrating efficacy and safety in each intended use population separately

However, GMP certification covers manufacturing process rather than product efficacy