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Caveat #1: Reports can be made by anyone Reports to FAERS can be made by consumers (i.e., the general public) and healthcare professionals alike

The FDA approval process means these medications have been studied in large clinical trial populations, their manufacturing facilities are inspected by the FDA, and their labeling (including dosing instructions, warnings, and side effects) has been reviewed and approved by federal regulators

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The decision point is financial

39 For these high-risk candidates, the 503B should pre-emptively establish relationships with API suppliers, develop and validate compounding and testing protocols, and prepare the necessary documentation