FDA’s final SIUU guidance loosens some off-label communication rules, but drugmakers still face strict compliance demands to ...
On January 7, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance document titled "Communications From Firms to Health Care Providers Regarding Scientific Information on ...
On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved / Cleared Medical Products ...
The US Food and Drug Administration (FDA) relies mainly on direct reports and regulator-initiated surveillance to flag safety concerns around medical devices, a system that may delay detection of ...
There is a significant reliance on manual workarounds. When a drug becomes unavailable, pharmacy teams may need to compound ...
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