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Most side effects are mild and tend to decrease over time

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Emerging causes of drug-induced anaphylaxis: a review of anaphylaxis-associated reports in the fda adverse event reporting system (FAERS)

Therefore, we recommend that companies determine their regulatory pathway to market in 2025-2026 and consider pre-subs in 2026 to allow time to take action on any FDA feedback before submitting the premarket submission

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