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This alert explains FDAs concerns, the misbranding theories at issue, and key compliance considerations for telehealth, compounding, and life sciences companies.

Practical takeaway Until stronger evidence exists, the review argues the path forward is collaborative pregnancy registries + better real-world data, so inadvertent exposures can be counselled with confidenceand so we can finally test whether pharmacotherapy could ever play a role in carefully selected high-risk cases

For manufacturers looking for optimal uptake of their brands, knowing the potential areas for increased utilization management and anticipating them ahead of time can ensure broad and sustainable adoption

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