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The FDA has to require how to use these drugs safely."

Step 6: Staff hiring and training This step, which would require 1 to 2 months and could ideally occur at the same time as Step 5, would involve hiring skilled personnel, especially quality assurance, quality control, and production experts

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Some coverage has suggested FDA approval could come as early as summer 2026, but that remains conditional until trials finish and regulators formally approve it

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