Regulatory Affairs Professionals Society

FDA plans rules to rein in drug ads, enable proactive release of CRLs, and more

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...
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 ...
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 ...