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FDA Drug Safety Communication: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR
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FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use
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FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children
Safety Announcement [05-06-2013]  The U.S. Food and Drug Administration (FDA) is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence…
Drug Safety Communication: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)
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FAERS Quarterly Data Files Documentation
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FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death
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Funding and Support
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4th Annual FDA/DIA Statistics Forum: Integrating Knowledge in Clinical Development: Meta-analysis, Non-Inferiority, and Related Topics
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Small Business Education Series
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