Pedro Franco
Senior Director & Head of Europe Global Regulatory & Scientific Policy, Merck KGaA
Seminars
Tuesday 20th October 2026
Responding to New FDA Expanded Access Guidance & MFN Pricing: What Has Changed & What Access Teams Must Do Now
2:00 pm
- Interpreting recent FDA expanded access guidance on broader eligibility, sponsor responsibility, and proactive access planning – and what this changes in practice
- Understanding how MFN pricing dynamics are extending time to launch and increasing reliance on early and managed access pathways
- Aligning expanded access planning with pricing driven launch uncertainty without creating open ended access commitments
- Evaluating whether existing access governance, resourcing, and supply models are fit for increased regulatory expectation and prolonged pre commercial access
