JD Supra

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products ...
JD Supra

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

The 2023 SIUU Communication Draft Guidance (or “2023 Draft Guidance”) provides FDA’s interpretation of how unapproved uses of approved or cleared medical products can be communicated by firms in a ...