JD Supra

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

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 ...
JD Supra

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

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 ...
RAPS

FDA Begins Process of Overhauling Off-Label Communications Regulations

FDA Begins Process of Overhauling Off-Label Communications Regulations The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review ...
RAPS

Study calls for proactive surveillance of device AEs

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 ...