Renata Solis-Vega

Misaligned safety labels and promotional materials create compliance and patient safety risks.

Successful post-patent strategy depends on tailored approaches, not uniform cost cuts.

Parallel workstreams and governance structures prevent common day-one launch failures.

ISPOR and ICER standards now jointly determine what budget impact analyses payers will accept.

Pharma booth panels face the same FDA promotional rules as ads, and enforcement is accelerating.

Comparative claims demand rigorous proof, not marketing intuition.

Manufacturers must verify requests are unsolicited before sharing off-label drug information.

Spot the bottleneck before the FDA does by breaking cycle time into its four failing parts.

Sorting MLR reviews by actual risk accelerates approval while catching violations that matter.

Slow MLR review stems from poor submissions, not reviewer shortage.