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Step 5: FDA Decision The FDA issues one of three decisions: Approval The drug can be marketed and prescribed Complete Response Letter (CRL) The FDA identifies issues that must be resolved before approval Refuse to File The application is incomplete (rare at this stage) How Retatrutide Compares to Similar Drug Approvals Eli Lilly and Novo Nordisk have recently brought several GLP-1 receptor agonist drugs through the FDA process