early communication about an ongoing safety review
- Guideline or reference source
- FDADST An FDA Guide to Drug Safety Terms
- Definition
- This type of communication is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA shares information in the interest of informing doctors and patients about the issues that are under review and when FDA experts anticipate completing their review.
- Broader Term
- safety announcement
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