Unlock real-world evidence for regulatory decision making

Real-world evidence strengthens regulatory packages and boosts approval odds. Flatiron brings best-in-class data and experience engaging with major health authorities including the FDA, EMA, and PMDA—from initial authorization through post-approval.

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Case Studies

EMA

Pfizer used Flatiron RWD as an external comparator arm for its EMA submission for ELREXFIO®, a breakthrough bispecific antibody for adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies.

FDA

Amgen used Flatiron and Foundation Medicine’s linked Clinico-Genomic Database to find a substantial unmet medical need for aNSCLC patients with KRAS G12C mutation, leading to an accelerated approval for LUMAKRAS® by the FDA

EMA

Large pharma client used Flatiron RWE for EMA post-authorization efficacy study, softening SmPC warning labeling for CDK5/6i therapy

Confident commercial strategies start with real-world clarity

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Regulatory-grade RWD

World-class real-world data and insights that Health Authorities can trust.

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AI-powered insights

Access critical insights via Flatiron Telescope, our intuitive AI platform featuring advanced LLM tools and powerful analytical capabilities.

multi-disciplinary

Expertise

Partner with a team already engaged with global health authorities to support you at every step with deep RWE expertise across the regulatory lifecycle.

by the numbers

10+

years collaborating with the FDA

45+

global regulatory decisions supported by Flatiron since 2018

40+

briefing packages and FDA information requests supported

14

health authority meetings contributed to by Flatiron

17

unique FDA/EMA post-approval studies

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Flatiron at the heart of regulatory innovation

— Case study

Since 2016, we’ve partnered with the FDA’s Oncology Center of Excellence to help define the role of RWE in the regulatory process. Together, we’ve pioneered innovative RWD study designs and methodologies that have elevated the credibility of RWE and helped streamline regulatory pathways. These efforts are already delivering meaningful breakthroughs for our life sciences partners.

Learn more about RWE for regulatory decision making

How do we typically engage with your team?

  • Fit-for-purpose assessments

  • Strategy-focused workshops

  • Roadmap development

  • Risk analysis 

  • Post-marketing requirements and commitments

  • Briefing book development

  • Information request responses

  • Health Authority meeting preparation

  • Meeting prep and attendance


“Beyond knowledge of our own data, Flatiron leverages industry intelligence gathered from regulatory decisions involving RWE in oncology—whether using Flatiron data or not—to continually refine our strategies. This industry intelligence, combined with direct commentary received from regulators on Flatiron’s data, enables Flatiron to secure regulatory buy-in early, and ultimately, regulatory success.”

Lockwood Taylor

Head of Regulatory Strategy, Flatiron Health

Flatiron’s regulatory strategy in action

Connect with Flatiron’s Regulatory Experts

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