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I look forward to providing the keynote address at the upcoming Annual Sentinel Initiative Workshop in November. Join the discussion with scientists, industry partners, and patients to promote engagement and collaboration within the public health community.

Thank you to National Organization for Rare Disorders (NORD) for inviting me to speak at the Rare Diseases and Orphan Products Breakthrough Summit to contribute to critical discussions facing the rare disease community and to discuss clinical trial innovation. nordsummit.org

It is FDA’s role to ensure that drugs are safe and effective. Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step to propose removing oral phenylephrine because it is not effective as a nasal decongestant.

Since 2015, 60+ biosimilars have received FDA approval, saving healthcare systems over $36 billion, and improving access to life-changing, quality medicines. These resources can help facilitate conversations between HCPs and patients who can benefit from these treatment options.

CCRI represents a major step forward to unlock the potential of RWD to inform clinical & regulatory decisions. We are creating a focal point within CDER to identify ways we can utilize RWE to streamline the development of effective & safe medicines for conditions with unmet need.

As 2024 concludes, I want to extend a heartfelt thank you to CDER staff for your continued service and dedication to our public health mission, and to the nation for your trust and support. Wishing everyone a safe and joyful holiday season!