Articles tagged with “medical-affairs”

Learn the compliant process for answering off-label HCP inquiries. This guide details FDA guidance, medical information SOPs, and software for case management.

Learn how Generative AI (GenAI) applies to Medical Affairs in pharma. This guide covers key use cases, compliance guardrails, and the risks of using LLMs.

Learn why MSLs can discuss off-label data via scientific exchange while sales reps cannot, including FDA's 2023 SIUU guidance on firm-initiated scientific communications.

Updated 2026 guide to FDA off-label promotion regulations for MSL teams, covering the January 2025 SIUU guidance, September 2025 OPDP enforcement surge, USPI boundaries, and compliance best practices

Learn the complete KOL/HCP mapping process for pharma. This playbook covers data-driven methods for KOL identification, segmentation, and network analysis.

Practical guide for Market Access teams and field representatives on handling common payer objections in oncology, including strategies for verbal and written communications, real-world examples, and response frameworks.

A comprehensive guide to Key Opinion Leader (KOL) tiering in pharmaceutical marketing, covering definition, strategic importance, tiering criteria, engagement strategies, AI-powered platforms, and compliance considerations for U.S. pharma companies. Updated for 2026.