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Submit biologics ads/promos effortlessly with fda application form FDA-2253. Includes checkboxes for draft/final materials, annotated references, and current labeling copies. Accelerated approval? Submit drafts pre-launch and final versions 30 days pre-dissemination. Avoid penalties by ensuring risk-benefit balance and proper formatting for TV/radio ads (storyboards, timestamps). Electronic submissions accepted via ESG gateway

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