Handling Unsolicited Requests for Off-Label Drug Information
Manufacturers must verify requests are unsolicited before sharing off-label drug information.
Renata Solis-Vega
Section
MLR and promotional review
8 stories in MLR and promotional review.
Social Media Promotional Content Under FDA Off-Label Oversight
FDA targets off-label drug promotion on social media after a decade of regulatory neglect.
David Osei-Bonsu
Veeva Vault PromoMats Configuration for MLR Cycle Management
Configuration choices in lifecycle, workflow, and roles determine if MLR review takes days or weeks.
Marcus Thibodeau
FDA Draft Guidance on Directional Risk Information in Promotional Labeling
Sixteen-year-old draft rules now guide how FDA polices drug risk disclosures.
Priya Nambiar
MLR Review Metrics That Signal Process Breakdown
FDA enforcement letters in 2025 signal urgent need to catch MLR process failures early.
Renata Solis-Vega
Parallel Review Workflows in Pharma Promotional Development
Marcus Thibodeau
Annotated Promotional Piece Requirements for MLR Submissions
Every claim in a drug ad must trace back to documented sources before FDA review.
Priya Nambiar
Risk-Based MLR Review Triage for Branded Drug Content
MLR teams need triage logic to stop reviewing low-risk content like high-stakes claims.
Renata Solis-Vega